Featured Study
A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries

Protocol #UCH12-1142, No Longer Enrolling: 5/20/2020

Displaying 1608 Active Studies, No Longer Enrolling
My Transgender Brain Study (MyT "Mighty" Brain) - Colorado


Protocol #18-1740, No Longer Enrolling: 8/24/2021
Locations: Anschutz Health and Wellness, Outpatient CTRC, UCD Anschutz Health & Wellness Center, University of Colorado Hospital

Neurocognitive Targets of Hostile Interpretation Bias Training to Treat Irritability

This trial lays the foundation for a preliminary test of efficacy of IBT on irritability by establishing IBT's neurocognitive treatment targets: hostile interpretation bias and response in the neural threat-learning system. The design will test whether active relative to sham IBT shifts the indifference point towards more benign judgments. Neural response to active versus sham IBT will be measured in half the sample. Hostile interpretation bias may be a feature of severe, chronic irritability in children, one of the most common psychiatric symptoms of childhood. Interpretation bias training (IBT) is a computer-based training program that may reduce irritability in youths. This trial lays the groundwork for a test IBT on irritability. This trial lays the foundation for a preliminary test of efficacy of IBT on irritability by establishing IBT's neurocognitive treatment targets: hostile interpretation bias and response in the neural threat-learning system. The design is a single-blinded, randomized controlled trial of IBT on its targets. The study will have four arms, with 25 participants in each arm for all four conditions of training (active versus sham) and scanning (in MRI or out of MRI scanner). During IBT, participants judge as happy or angry facial expressions which are on a continuum between happy and angry. The point at which judgments shift from predominantly happy to angry on this continuum is the indifference point. During training feedback encourages no change in the indifference point or a change in the indifference point towards more happy judgments of ambiguous faces. A shift in indifference point towards more benign judgments is interpreted as a reduction in hostile interpretation. The design will test whether active relative to sham IBT shifts the indifference point towards more benign judgments. Neural response to active versus sham IBT will be measured in half the sample.
Protocol #17-0464, No Longer Enrolling: 4/15/2023
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03592368

Relationship of hair cortisol to diurnal salivary cortisol and psychological distress measures

The purpose of this research is to demonstrate a relationship between cortisol measured in hair, cortisol measured in saliva, and the results of self-reported psychological measures (questionnaires).
Protocol #20-0025, No Longer Enrolling: 1/21/2021
Locations: Department Specific Free Standing Clinic

The role of biological sex in perceived stress and negative affect in the context of 2 systemic societal stressors

This study is completed online at your convenience. Participants will complete online surveys (the study takes about 25 minutes to complete).
Protocol #20-1583, No Longer Enrolling: 10/14/2020
Locations: Department Specific Free Standing Clinic

Improving sleep in healthcare providers: effects of Bose noise-masking Sleepbuds(tm)

Study participants will: 1. Participate in 2 study sessions, done online or in-person, over the course of 2 weeks 2. Wear sleep study devices for 10 nights (at home) 3. Complete interviews and questionnaires
Protocol #21-2676, No Longer Enrolling: 8/6/2022
Locations: University of Colorado Hospital

Human Laboratory Study of ASP8062 for Alcohol Use Disorder

For more information, please email the research team at alcoholstudy@ucdenver.edu or use the link to fill out the study contact information form: https://redcap.link/TrAIL_Lab For participating in the research study, you will be paid up to a total of $595.00. Payments will be pro-rated if you don't complete all parts of the study. The primary objective of this study is to evaluate the effects of ASP8062, 25 mg once a day and matched placebo, on alcohol cue-elicited alcohol craving during a human laboratory paradigm after 2 weeks of daily dosing among subjects with moderate to severe alcohol use disorder (AUD).
Protocol #21-4460, No Longer Enrolling: 4/27/2022
Locations: Department Specific Free Standing Clinic, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05096117

A Pilot Feasibility Test of a Digital Solution for Remote Mental Health Monitoring and Care

If you join the study, you will first complete an initial baseline questionnaire about your mental health, general health, your experience with mental health care services, and demographic information (e.g., gender, age) about you. You will be emailed instructions on how to install the HR system on your smartphone via an app called Cue. The first time you launch the app, you will go through an onboarding training on how to use the system and how to complete study activities. The study has two phases. The first phase will last 3 weeks and looks at the functionality of the HR system. It will evaluate whether things like whether the system is properly uploading your information into your medical record or if it’s sending alerts about your mental health to your provider and/or the study team in an accurate and timely fashion. The second phase will last 6 weeks and looks at the feasibility of using the app to help with mental health care. We will be learning about how user-friendly the system is and whether or not it is a good way to monitor people’s mental health as well as provide and facilitate mental health care. You may be able to participate in one or both phases.
Protocol #21-4903, No Longer Enrolling: 11/12/2022
Locations: University of Colorado Hospital

Feasibility of Reducing Cardiovascular Disease Risk Factors in Hispanics through a Family-Based Community Intervention


Protocol #21-4605, No Longer Enrolling: 3/14/2023
Locations: Medical Center of the Rockies
More information available at ClinicalTrials.gov: NCT05322876

A double-blind, placebo-controlled crossover study comparing the analgesic efficacy of cannabis versus oxycodone

PRIMARY AIMS: (1) To compare the effects of cannabis versus oxycodone versus placebo on spontaneous chronic spine pain relief, as measured by change in score on the 10-point Numeric Rating Scale (NRS); (2) To compare the effects of cannabis versus oxycodone versus placebo on experimental pain analgesia, as measured by change in Experimental Pain Threshold (EPTh), in both patients with chronic spine pain and healthy controls. SECONDARY AIMS: (1) To compare the effects of cannabis versus oxycodone versus placebo on chronic spine pain, as measured by the Patient Global Impression of Change (PGIC) scale; (2) To compare the effects of cannabis versus oxycodone versus placebo on subjective reports of drug effects, psychoactive effects, and mood; (3) To compare the effects of cannabis versus oxycodone versus placebo on tests of neurocognitive functioning (Wechsler Adult Intelligence Scale (WAIS-III) Digit Symbol Test, the Hopkins Verbal Learning Test Revised (HVLT), and the Grooved Pegboard Test); (4) To compare the effects of cannabis versus oxycodone versus placebo on Standardized Field Sobriety Tests (SFST).
Protocol #14-1909, No Longer Enrolling: 8/1/2023
Locations: CTRC-adult, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02892591

The SUN Clinical Trial: Safety Utilizing NUsurface Meniscus Implant. A multi-center, single-arm, prospective, open label, non-randomized, observational clinical study


Protocol #15-1356, No Longer Enrolling: 10/1/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02483988

A Clinical Study to Assess the Safety and Effectiveness of the Premia Spine TOPS System


Protocol #17-0054, No Longer Enrolling: 3/11/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03012776

Analysis of Discarded Spinal Tissues from Individuals with Spinal Conditions


Protocol #17-0687, No Longer Enrolling: 4/14/2022
Locations: University of Colorado Hospital

Study of bone growth in the Sacroiliac Joint after minimally invasive surgery with titanium implants


Protocol #17-0371, No Longer Enrolling: 1/8/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03122899

DHEA Augmentation of Musculoskeletal Adaptations to Exercise in Older Women

If you join the study, you will be placed by chance into one of two research groups: 1) exercise and a study pill or 2) no exercise and a study pill. The study pill could be DHEA (50 mg/day) or a placebo. A placebo is a pill that looks like medicine but is not real. DHEA is a naturally occurring hormone that declines with age. In postmenopausal women, nearly all estrogen and most testosterone comes from DHEA. DHEA is considered a food supplement.
Protocol #16-2427, No Longer Enrolling: 9/20/2023
Locations: Brain Imaging Center - BIC, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03227458

A Multi-Center, Open-Label, Prospective Study of CervicalStim device as Adjunctive Care following Cervical Fusion


Protocol #17-1013, No Longer Enrolling: 8/25/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03177473

SMART: A prospective, multi-center registry assessing the embolization of neurovascular lesions using the Penumbra SMART COIL? System

This is a prospective, multi-center registry of patients treated in accordance with the cleared indications for the Smart, Penumbra Coil 400, and the Penumbra Occlusion Device. Data for each patient are collected in accordance with the standard of care at each participating hospital through one-year follow-up.
Protocol #17-2122, No Longer Enrolling: 7/17/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02729740

A Prospective Multicenter Open-label Randomized Controlled Trial of Agili-C vs. Surgical Standard of Care (SSOC) for the Treatment of Joint Surface Lesions of the Knee

The Agili-C™ scaffold is indicated for the treatment of an ICRS grade III or above knee-joint surface lesion(s), with a total treatable area of 1-7cm2 and without severe osteoarthritis (Kellgren-Lawrence grade 0-3)
Protocol #18-2105, No Longer Enrolling: 1/3/2020
Locations: Boulder Sports Clinic, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03299959

A Prospective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children with Osteogenesis Imperfecta V: 24 March 2016


Protocol #18-0073, No Longer Enrolling: 1/15/2020
Locations: Childrens Hospital Colorado

Acute application of intrawound antibiotic powder in open extremity fracture wounds

We aim to investigate the effectiveness of preoperative intrawound antibiotic powder in preventing infection and reducing bacterial burden after open fracture.
Protocol #20-2957, No Longer Enrolling: 1/10/2024
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04872400

Effectiveness of Gastrocnemius Stretching

Specific Aim 1: To evaluate EMG activity of the tibialis posterior muscle during four different common gastrocnemius stretches. The dependent variable for Aim 1 is EMG activation of the tibialis posterior muscle. The independent variable for Aim1 is stretching position. Specific Aim 2: To evaluate radiographically the angle of the tibia and calcaneus between four different common gastrocnemius stretches. The dependent variable for Aim 2 is angle and the independent variable for Aim 2 is stretching position.
Protocol #21-4011, No Longer Enrolling: 7/8/2022
Locations: Highlands Ranch Hospital

A Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 Delivered By Single or Multi-Dose Intravitreal Injections(s) to Subjects With Acute Nonarteritic Anterior Ischemic Optin Neuropathy (NAION)

1. To assess the safety and tolerability of QPI-1007 intravitreal (IVT) injections in subjects with recent-onset NAION 2. To determine the effect on visual function of QPI-1007 IVT injections in subjects with recent-onset NAION
Protocol #15-1194, No Longer Enrolling: 11/20/2019
Locations: University of Colorado Hospital

A Multicenter, Open-Label, Extension Study to Evaluate the Long-term Safety and Efficacy of Patisiran in Patients with Familial Amyloidotic Polyneuropathy Who Have Completed a Prior Clinical Study with Patisiran

To assess the safety and efficacy of long-term dosing with patisiran in transthyretin-mediated amyloidosis (ATTR) patients with familial amyloidotic polyneuropathy (FAP).
Protocol #15-1259, No Longer Enrolling: 4/25/2020
Locations: University of Colorado Hospital

A Phase 3 Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and the Safety of Gastric Retentive, Controlled Release Accordion Pill Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson's Disease Patients

To assess the safety, tolerability and efficacy of Accordion Pill carbidopa/levodopa (AP-CD/LD) compared to Immediate Release carbidopa/levodopa (IR CD/LD) in fluctuating PD patients
Protocol #15-2350, No Longer Enrolling: 10/1/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02605434

An Open-Label, Phase 3 Study Examining the Long-Term Safety Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients with Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)

To evaluate the safety and tolerability of APL-130277 in patients with Parkinson's disease (PD) over a 24 week period
Protocol #16-0684, No Longer Enrolling: 1/29/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02542696

Collaborative International Research in Clinical and Longitudinal Experience for Neuromyelitis Optica (NMO) Studies

To create a longitudinal collections of samples and data from: 1. Subjects with clinically-defined or highly suspicious for NMO or NMOSD; 2. Affected or unaffected relatives of subjects with clinically defined NMO or NMOSD; 3. Subjects with autoimmune diseases other NMO or NMOSD, such as multiple sclerosis, myasthenia gravis, Graves' disease, lupus, etc. 4. Healthy subjects
Protocol #13-3181, No Longer Enrolling: 3/5/2022
Locations: University of Colorado Hospital

A Double-Masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

To compare the efficacy of MEDI-551 versus placebo in reducing the risk of an NMO/NMOSD attack in subjects with NMO/NMOSD.
Protocol #14-0926, No Longer Enrolling: 4/25/2020
Locations: University of Colorado Hospital

RNS System Post-Approval Study in Epilepsy

To calculate annual SAE rate over time in patients treated with RNS System
Protocol #15-1458, No Longer Enrolling: 11/2/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02403843

A randomized, double-blind, placebo-controlled trial of urate-elevating inosine treatment to slow clinical decline in early Parkinson!?s disease

To determine whether oral inosine dosed to moderately elevate serum urate (from !U5.7 mg/dL to 7.1-8.0 mg/dL) over 2 years slows clinical decline in early PD.
Protocol #15-2328, No Longer Enrolling: 11/14/2019
Locations: University of Colorado Hospital

NAtalizumab for Prevention of Post-partum Relapses in patients with Multiple Sclerosis 09May2016

To assess the efficacy of IV administered natalizumab, monthly for 1 year, in preventing relapses during the postpartum period.
Protocol #16-0156, No Longer Enrolling: 3/17/2022
Locations: University of Colorado Hospital

Wireless electroencephalography for continuous monitoring in the EEG LTM unit 12Apr2018

1. To evaluate the device?s ability to record wireless EEG from patients in the long-term EEG monitoring unit 2. To compare wireless EEG in these recordings to standard-of-care wired EEG
Protocol #15-0449, No Longer Enrolling: 8/10/2021
Locations: University of Colorado Hospital

A Phase IV Trial of Neuroprotection with ACTH in Acute Optic Neuritis


Protocol #13-0388, No Longer Enrolling: 1/29/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT01838174

A Phase 3, Open-Label Study of the Safety, Efficacy, and Tolerability of Apomorphine Administered by Continuous Subcutaneous Infusion in Advanced Parkinson's Disease Patients with Unsatisfactory Control on Available Therapy.

To assess the long-term safety of apomorphine continuous infusion in advanced Parkinson?s disease (PD) patients who are unable to achieve adequate motor control despite optimal treatment with noninvasive therapy.
Protocol #15-1274, No Longer Enrolling: 4/25/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02339064

A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312

To demonstrate the efficacy of BAF312 relative to placebo in delaying the time to 3-month confirmed disability progression in patients with SPMS as measured by EDSS.
Protocol #13-2286, No Longer Enrolling: 4/15/2020
Locations: University of Colorado Hospital

A Phase III, multicentre, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis

To investigate the efficacy of ocrelizumab compared with placebo in patients with primary progressive multiple sclerosis, as measured by the time to onset of confirmed disability progression over the treatment period, defined as an increase in EDSS that is sustained for at least 12 weeks, based on regularly scheduled visits.
Protocol #11-1327, No Longer Enrolling: 11/12/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT01194570

A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study to Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1A (Rebif ?) in Patients with Relapsing Multiple Sclerosis

To assess whether the efficacy of ocrelizumab 600 mg (given as dual infusions of 300 mg on Days 1 and 15 of the first 24-week treatment cycle and as a single infusion of 600 mg on Day 1 of each 24-week treatment cycle thereafter) intravenously every 24 weeks is superior to Rebif? as measured by the annualized protocol-defined relapse rate by two years (96 weeks) in patients with relapsing multiple sclerosis.
Protocol #11-1850, No Longer Enrolling: 11/12/2019
Locations: University of Colorado Hospital

Effect of MD1003 in progressive multiple sclerosis: a randomized double blind placebo controlled study

To demonstrate the superiority of MD1003, 300 mg/day, over placebo to clinically improve patients with progressive multiple sclerosis (MS).
Protocol #16-1727, No Longer Enrolling: 4/25/2020
Locations: University of Colorado Hospital

A Multicenter, Double-Blind, Double-Dummy Study to Explore the Long-Term Safety and Efficacy of TEV-48125 for the Prevention of Cluster Headache


Protocol #17-0089, No Longer Enrolling: 11/6/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03107052

Deep Brain Stimulation (DBS) of the Rostral Zona Incerta (rZI) for Parkinson's Disease (PD): Stereotactic Targeting and Clinical Efficacy


Protocol #16-1443, No Longer Enrolling: 6/10/2021
Locations: University of Colorado Hospital

Cognition and Neurodevelopmental Influence (CANDI)


Protocol #17-0207, No Longer Enrolling: 12/10/2019
Locations: University of Colorado Hospital

10-1311 DoneSave Functional connectivity of the motor network in two major subtypes of Parkinson Disease December 24,2015


Protocol #10-1311, No Longer Enrolling: 7/30/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT01798563

Dystonia Coalition Project 1: Natural History and Biospecimen Repository for Dystonia


Protocol #11-0647, No Longer Enrolling: 5/10/2021
Locations: University of Colorado Hospital

MULTICENTER 1-YEAR OBSERVATIONAL STUDY OF PATIENTS WHO ARE INITIATING BRIVARACETAM


Protocol #17-0679, No Longer Enrolling: 10/9/2020
Locations: University of Colorado Hospital

Diagnostic and Rating Tools for Blepharospasm


Protocol #16-0017, No Longer Enrolling: 5/10/2021
Locations: University of Colorado Hospital

A Phase III, Multicentre, Randomised, Double Blind, Parallel Group, Placebo Controlled Study to Assess the Efficacy And Safety of One or More Intradetrusor Treatments of 600 or 800 Units of Dysport? For The Treatment Of Urinary Incontinence In Subjects With Neurogenic Detrusor Overactivity Due to Spinal Cord Injury or Multiple Sclerosis


Protocol #16-0644, No Longer Enrolling: 11/14/2019
Locations: University of Colorado Hospital

Stereotactic Laser Ablation for Temporal Lobe Epilepsy (SLATE) Study


Protocol #17-0873, No Longer Enrolling: 6/2/2023
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02844465

Evaluating the Tolerability and Safety Profile of Switching from Rituximab to Ocrelizumab: A Real World Evaluation of Patients with Relapsing Forms of Multiple Sclerosis


Protocol #16-1354, No Longer Enrolling: 12/12/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02980042

Using Next Generation Sequencing to Unravel the Pathogenesis of Sporadic Inclusion Body Myositis (IBM) - The International IBM Consortium Genetic Study


Protocol #17-1132, No Longer Enrolling: 4/11/2023
Locations: University of Colorado Hospital

Phase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE II STUDY)


Protocol #17-1170, No Longer Enrolling: 6/27/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03277248

A Randomized, Double-Blind, Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of FLX-787-ODT for Treatment of Muscle Cramps in Adult Subjects with Motor Neuron Disease


Protocol #17-1335, No Longer Enrolling: 10/1/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03196375

BEnefits of Stroke Treatment Delivered Using a Mobile Stroke Unit Compared to Standard Management by Emergency Medical Services: The BEST-MSU Study


Protocol #15-2114, No Longer Enrolling: 5/20/2021
Locations: Memorial Hospital Central, University of Colorado Hospital

The modified Atkins diet in patients with drug resistant epilepsy and the responsive neurostimulator 09Aug2017


Protocol #17-0888, No Longer Enrolling: 5/12/2023
Locations: University of Colorado Hospital

PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF OCTAGAM 10% IN PATIENTS WITH DERMATOMYOSITIS


Protocol #17-1396, No Longer Enrolling: 10/1/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02728752

Transcranial electrical stimulation for the treatment of cervical dystonia


Protocol #17-1322, No Longer Enrolling: 10/12/2021
Locations: Colorado Research Center, Department Specific Free Standing Clinic

Topiramate as a disease altering therapy for Cryptogenic Sensory Peripheral Neuropathy (CSPN)


Protocol #17-1751, No Longer Enrolling: 9/25/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02878798

Protocol I7S-MC-HBEH Effect of LY3154207 on Cognition in Mild-to-Moderate Parkinson's Disease Dementia (PDD) (The PRESENCE Study)


Protocol #17-1825, No Longer Enrolling: 2/22/2020
Locations: University of Colorado Hospital

Phase 2/3 Study of Arimoclomol in Inclusion Body Myositis (IBM)


Protocol #17-1854, No Longer Enrolling: 11/19/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02753530

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson's Disease


Protocol #17-1532, No Longer Enrolling: 10/20/2021
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03318523

Management of Acute Stroke Patients on Treatment with New Oral Anticoagulants: Addressing Realworld Anticoagulant Management Issues in Stroke (ARAMIS) Registry

The ARAMIS registry is designed to provide important and timely insight into the management of acute stroke patients who are on novel oral anticoagulant in community practice
Protocol #17-6111, No Longer Enrolling: 2/18/2020
Locations: Medical Center of the Rockies, Poudre Valley Hospital
More information available at ClinicalTrials.gov: NCT02478177

A PHASE 2, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTIPLE DOSE STUDY OF CK-2127107 IN TWO ASCENDING DOSE COHORTS OF PATIENTS WITH SPINAL MUSCULAR ATROPHY (SMA)


Protocol #17-1816, No Longer Enrolling: 6/20/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02644668

Phase 2 Study of Allogeneic Umbilical Cord Blood Infusion for Adults with Ischemic Stroke - CoBIS 2

The primary objective of the study is to determine, in a randomized, placebo controlled trial, the efficacy of a single intravenous (IV) infusion of unrelated donor UCB for improving functional outcomes in patients with ischemic stroke. The secondary objectives are as follows: 1.To describe the safety and tolerability of a single IV infusion of unrelated donor UCB in patients with ischemic stroke 2.To evaluate the efficacy of a single IV infusion of unrelated donor UCB for improvement of neurological symptoms following ischemic stroke 3.To evaluate the efficacy of a single IV infusion of unrelated donor UCB for improvement in quality of life and emotional and cognitive status in patients with ischemic stroke
Protocol #17-2136, No Longer Enrolling: 5/20/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03004976

American Registry for Migraine Research


Protocol #17-2165, No Longer Enrolling: 5/11/2021
Locations: Lone Tree Medical Center, UCHealth Internal Medical Clinic - Lowry, University of Colorado Hospital

A randomized, double blind, placebo-controlled parallel study of tolerability and efficacy of Cannabidiol (CBD) on tremor in Parkinson's disease


Protocol #17-2318, No Longer Enrolling: 11/20/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03582137

Long-term, prospective, multinational, parallel-cohort study monitoring safety in patients with MS newly started on fingolimod once daily or treated with another approved disease-modifying therapy


Protocol #15-0657, No Longer Enrolling: 2/27/2020
Locations: University of Colorado Hospital

AN OPEN-LABEL, MULTICENTER, BIOMARKER STUDY TO EXPLORE THE MECHANISM OF ACTION OF OCRELIZUMAB AND B-CELL BIOLOGY IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS OR PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS


Protocol #16-0120, No Longer Enrolling: 11/12/2019
Locations: University of Colorado Hospital

Determining the Optimal Treatment Strategy for Patients who have Chronic Migraine with Medication Overuse


Protocol #16-2179, No Longer Enrolling: 5/11/2021
Locations: University of Colorado Hospital

A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens (Intravenous/Subcutaneous and Subcutaneous) of TEV-48125 versus Placebo for the Prevention of Episodic Cluster Headache


Protocol #17-0087, No Longer Enrolling: 11/6/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02945046

A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens (Intravenous/Subcutaneous and Subcutaneous) of TEV-48125 versus Placebo for the Prevention of Chronic Cluster Headache


Protocol #17-0088, No Longer Enrolling: 10/1/2019
Locations: University of Colorado Hospital

Validation of a performance-based assessment of functional ability related to cognition in Parkinson's disease


Protocol #15-0170, No Longer Enrolling: 8/4/2022
Locations: Colorado Research Center, Department Specific Free Standing Clinic, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital

A Proof of Concept Study to Investigate the Effect of IPT803 Adjunct Treatment in Patients with Parkinson's Disease


Protocol #18-0113, No Longer Enrolling: 3/12/2020
Locations: Anschutz Health and Wellness, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03407378

Clinical Trial Readiness for SCA1 and SCA3


Protocol #18-0020, No Longer Enrolling: 5/4/2022
Locations: University of Colorado Hospital

Perceived palliative care needs of Huntington's disease patients


Protocol #18-0216, No Longer Enrolling: 1/30/2024
Locations: University of Colorado Hospital

Multiple-Biopsy of Infiltrative Glioma (M-BIG) Study


Protocol #17-2111, No Longer Enrolling: 4/15/2020
Locations: Childrens Hospital Colorado

Application of transcranial alternating current stimulation for modulation of sleep and cognitive performance

1).Optimize tACS parameters for duration, intensity and frequencies via utilization of EEG data recorded during tACS stimulation. 2)Determine whether recording artifacts introduced by tACS can confidently be removed from EEG signals. 3). Determine effects of tACS delivered with nested frequencies(multi-frequency signal) vs single frequency tACS, with regard to intrinsic EEG signal, for modulation of SWA coherence and power, as recorded in our overnight EEG sleep data. 4). Determine the cumulative effects of tACS delivered in multiple, consecutive nights on underlying EEG signals, sleep architecture, sleep quality and cognitive function among patients with MCI. 5). Determine if tACS is a viable treatment for disturbances of sleep and cognitive performance among patients with MCI. 6). Generate pilot data and manuscripts to support applications for larger randomized placebo-controlled clinical trials.
Protocol #16-1875, No Longer Enrolling: 5/5/2021
Locations: Colorado Research Center, Department Specific Free Standing Clinic, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03112902

Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS)


Protocol #15-2388, No Longer Enrolling: 11/13/2020
Locations: University of Colorado Hospital

AMPLATZERTM PFO Occluder Post Approval Study


Protocol #17-2334, No Longer Enrolling: 10/14/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03309332

A 3-ARM, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ADS-5102 AMANTADINE EXTENDED RELEASE CAPSULES IN MULTIPLE SCLEROSIS PATIENTS WITH WALKING IMPAIRMENT


Protocol #18-0375, No Longer Enrolling: 12/20/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03436199

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies


Protocol #18-0482, No Longer Enrolling: 4/25/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03222973

Multicenter, randomized, double-blind, parallel-group, add-on, superiority study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera?)


Protocol #16-2178, No Longer Enrolling: 10/1/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02907177

The Role Of Th40 Cells In Multiple Sclerosis And Type 1 Diabetes Subjects


Protocol #08-0613, No Longer Enrolling: 10/1/2019
Locations: University of Colorado Hospital

AN OPEN-LABEL, MULTI-CENTER, FOLLOW-UP STUDY DESIGNED TO EVALUATE THE LONG-TERM EFFECTS OF AP-CD/LD IN FLUCTUATING PARKINSON'S DISEASE SUBJECTS WHO COMPLETED STUDY IN 11 004


Protocol #15-2351, No Longer Enrolling: 11/6/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02615873

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of ACE-083 in Patients with Facioscapulohumeral Muscular Dystrophy


Protocol #18-0787, No Longer Enrolling: 11/22/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02927080

A Randomized, Placebo Surgery Controlled, Double-blinded, Multi-center, Phase 2 Clinical Trial, Evaluating the Efficacy and Safety of VY-AADC02 in Advanced Parkinson's Disease with Motor Fluctuations

Study is double blind and placebo controlled.
Protocol #18-0829, No Longer Enrolling: 5/10/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03562494

Multi-center, randomized, double-blinded assessment of Tecfidera? in extending the time to a first attack in radiologically isolated syndrome (RIS) (ARISE)


Protocol #16-0121, No Longer Enrolling: 1/6/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02739542

Ruptured Aneurysms Treated with Hydrogel Coils

To determine occlusion rates and safety when hydrogel coils are used in the treatment of ruptured intracranial aneurysms.
Protocol #18-6052, No Longer Enrolling: 11/16/2022
Locations: Memorial Hospital Central
More information available at ClinicalTrials.gov: NCT03252314

Timing of Facial Movements for Posed and Spontaneous Facial Expressions V:30Jan2018


Protocol #17-0599, No Longer Enrolling: 10/28/2020
Locations: University of Colorado Hospital

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of ACE-083 in Patients with Charcot-Marie-Tooth Disease Types 1 and X. 01Mar2018


Protocol #18-0996, No Longer Enrolling: 11/6/2019
Locations: Brain Imaging Center (BIC), Colorado Research Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03124459

Microburst VNS Therapy Feasibility Study in Patients with Refractory Epilepsy


Protocol #18-0995, No Longer Enrolling: 6/10/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03446664

A PHASE IIIB, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF SHORTER INFUSIONS OF OCRELIZUMAB IN PATIENTS WITH PRIMARY PROGRESSIVE AND RELAPSING MULTIPLE SCLEROSIS


Protocol #18-1262, No Longer Enrolling: 11/6/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03606460

More than a Movement Disorder: Applying Palliative Care to Parkinson?s Disease v: 12/06/2017


Protocol #16-1400, No Longer Enrolling: 8/9/2023
Locations: Colorado Research Center, Department Specific Free Standing Clinic

A Phase 2b/3 Prospective, Randomized, Double-Blind, Sham-Controlled Trial of VTS-270 (2-hydroxypropyl-a-cyclodextrin) in Subjects with Neurologic Manifestations of Niemann-Pick Type C1 (NPC1) Disease


Protocol #18-0997, No Longer Enrolling: 4/25/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02534844

A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients


Protocol #18-1592, No Longer Enrolling: 11/6/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03560739

A Phase 3, Randomized, Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine with Lomustine Compared to Lomustine Alone in Patients with Anaplastic Astrocytoma That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy STELLAR Study


Protocol #18-1336, No Longer Enrolling: 3/3/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02796261

Advanced Directives in Amyotrophic Lateral Sclerosis: Preferences and Circumstances Surrounding End-of-Life Decision Making


Protocol #17-2029, No Longer Enrolling: 11/14/2019
Locations: University of Colorado Hospital

A Phase III, Long-Term, Randomized, Double-blind, Placebo-controlled Trial of BHV-4157 in Adult Subjects with Spinocerebellar Ataxia


Protocol #18-1875, No Longer Enrolling: 12/4/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03701399

A RANDOMIZED CONTROLLED STUDY TO COMPARE THE SAFETY AND EFFICACY OF IPX203 WITH IMMEDIATE-RELEASE CARBIDOPA-LEVODOPA IN PARKINSON'S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS


Protocol #18-2047, No Longer Enrolling: 5/10/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03670953

Genomic Translation for ALS Care


Protocol #18-1768, No Longer Enrolling: 5/11/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02795897

An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis


Protocol #18-2059, No Longer Enrolling: 11/22/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03650114

Safety and Efficacy Study of Elezanumab (ABT-555) in Progressive Forms of Multiple Sclerosis


Protocol #18-2152, No Longer Enrolling: 4/25/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03737812

Safety and Efficacy Study of Elezanumab (ABT-555) in Relapsing Forms of Multiple Sclerosis


Protocol #18-2451, No Longer Enrolling: 4/25/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03737851

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis


Protocol #18-2341, No Longer Enrolling: 4/25/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03772587

A PHASE 1B, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY TO DETERMINE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF DNL201 IN SUBJECTS WITH PARKINSON'S DISEASE


Protocol #18-2423, No Longer Enrolling: 2/29/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03710707

HELIOS-A: A Phase 3 Global, Randomized, Open-label Study to Evaluate the Efficacy and Safety of ALN-TTRSC02 in Patients with Hereditary Transthyretin Amyloidosis (hATTR Amyloidosis)


Protocol #18-2237, No Longer Enrolling: 11/22/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03759379

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness


Protocol #18-2536, No Longer Enrolling: 11/6/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03669588

Investigating the Contribution of Peripheral versus Central Nervous System Immune Dysfunction to Cognitive Aging


Protocol #18-2607, No Longer Enrolling: 4/13/2023
Locations: Brain Imaging Center - BIC, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital

A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment


Protocol #18-2535, No Longer Enrolling: 11/22/2019
Locations: Brain Imaging Center (BIC), Colorado Research Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03689972

A MULTICENTER, OPEN-LABEL SAFETY AND EFFICACY STUDY OF ADS-5102 AMANTADINE EXTENDED RELEASE CAPSULES IN PATIENTS WITH MULTIPLE SCLEROSIS AND WALKING IMPAIRMENT


Protocol #19-0363, No Longer Enrolling: 4/25/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03567057

Detection and Risk in Early MS


Protocol #19-0393, No Longer Enrolling: 8/11/2021
Locations: Brain Imaging Center (BIC), University of Colorado Hospital

Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion


Protocol #19-0025, No Longer Enrolling: 2/21/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03781167

A Phase I/II Study of Nivolumab Plus or Minus Ipilimumab in Combination with Multi-Fraction Stereotactic Radiosurgery for Recurrent High-Grade Radiation-Relapsed Meningioma


Protocol #19-0423, No Longer Enrolling: 7/19/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03604978

A 14-Week, Double-Blind, Randomized, Three-Arm, Parallel Group Study to Assess the Efficacy and Safety of Two Doses of Pridopidine versus Placebo for the Treatment of Levodopa-Induced Dyskinesia in Patients with Parkinson's Disease (gLIDe)


Protocol #19-0478, No Longer Enrolling: 7/7/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03922711

A Phase 3, 4-week, Multicenter, Randomized, Double-blind, Placebocontrolled, Parallel-group Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure


Protocol #19-0414, No Longer Enrolling: 5/10/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03750552

Instrumentation of Huntington's Disease Motor Function Assessment


Protocol #19-0212, No Longer Enrolling: 5/5/2021
Locations: University of Colorado Hospital

A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD˗9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure


Protocol #19-0520, No Longer Enrolling: 5/10/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03829657

An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis


Protocol #19-0150, No Longer Enrolling: 5/11/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03896295

An Open-Label Extension Study to Evaluate the Long-Term Effects of ACE-083 in Patients with Facioscapulohumeral Muscular Dystrophy (FSHD) Previously Enrolled in Study A083-02 and in Patients with Charcot-Marie Tooth (CMT) Disease Types 1 and X Previously Enrolled in Study A083-03


Protocol #19-0720, No Longer Enrolling: 11/14/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03943290

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naive Adult Patients With Generalized Myasthenia Gravis


Protocol #19-0772, No Longer Enrolling: 5/11/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03920293

Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema following Large Hemispheric Infarction


Protocol #19-0675, No Longer Enrolling: 5/31/2023
Locations: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02864953

Gamma band neural stimulation and its effects on resting state networks


Protocol #19-1251, No Longer Enrolling: 5/5/2021
Locations: Brain Imaging Center (BIC), Department Specific Free Standing Clinic

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING EFFICACY AND SAFETY OF ROZANOLIXIZUMAB IN ADULT PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS


Protocol #19-1597, No Longer Enrolling: 6/24/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03971422

Neurological Screening of Controls in an Age-Related Macular Degeneration Registry


Protocol #19-1925, No Longer Enrolling: 9/14/2021
Locations: University of Colorado Hospital

A Double-Blind, Placebo-Controlled, Inpatient, Dose-Ranging Efficacy Study of Staccato Alprazolam (STAP-001) in Subjects with Epilepsy with a Predictable Seizure Pattern


Protocol #19-1396, No Longer Enrolling: 2/7/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03478982

A Double-Blind, Placebo-Controlled 16-Week Study of the Cognitive Effects of the Oral P38 Alpha Kinase Inhibitor Neflamapimod in Dementia with Lewy Bodies (DLB)


Protocol #19-1599, No Longer Enrolling: 3/28/2020
Locations: Brain Imaging Center (BIC), University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04001517

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 as Adjunctive Therapy in Focal-onset Epilepsy


Protocol #19-1620, No Longer Enrolling: 4/6/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03796962

A RANDOMIZED, OPEN-LABEL EXTENSION STUDY TO INVESTIGATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF ROZANOLIXIZUMAB IN ADULT PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS


Protocol #19-1929, No Longer Enrolling: 5/13/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04124965

A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF SUBCUTANEOUS OCRELIZUMAB ADMINISTRATION IN PATIENTS WITH MULTIPLE SCLEROSIS


Protocol #19-1040, No Longer Enrolling: 6/8/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03972306

AN OPEN-LABEL EXTENSION STUDY OF THE SAFETY AND CLINICAL UTILITY OF IPX203 IN PARKINSON'S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS


Protocol #19-1461, No Longer Enrolling: 3/17/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03877510

An investigation of immune biology and Alzheimers Disease-related biomarkers in asymptomatic, late life mild TBI


Protocol #19-1423, No Longer Enrolling: 5/26/2023
Locations: Brain Imaging Center - BIC, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital

Natural History of Rett Syndrome and Related Disorders


Protocol #15-2332, No Longer Enrolling: 3/7/2023
Locations: Childrens Hospital Colorado

A Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (HYQVIA/HyQvia) and Immune Globulin Infusion (Human), 10% (GAMMAGARD LIQUID/KIOVIG) for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)


Protocol #19-1455, No Longer Enrolling: 6/10/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02549170

Feasibility of the Multiple Sclerosis Performance Test for assessment of functional performance measures in patients with Multiple Sclerosis


Protocol #19-1192, No Longer Enrolling: 9/16/2022
Locations: University of Colorado Hospital

A Multi-center, Prospective, Longitudinal, Digital Assessment Study of Disease Progression in Subjects with Early, Untreated Parkinson Disease (PD)


Protocol #19-0865, No Longer Enrolling: 5/10/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03681015

Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 36 Weeks of Treatment with NLY01 in Early-stage Parkinson's Disease


Protocol #19-2471, No Longer Enrolling: 3/30/2022
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04154072

A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy, Safety and Tolerability of ABBV-951 to Oral Carbidopa/Levodopa in Advanced Parkinson's Disease Patients


Protocol #19-2897, No Longer Enrolling: 4/17/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04380142

An open-label, non-randomized trial to investigate the efficacy and safety of early versus delayed start of arimoclomol in patients with sporadic inclusion body myositis who have completed the IBM4809 trial


Protocol #19-1598, No Longer Enrolling: 5/11/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04049097

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated with Huntington's Disease


Protocol #19-1840, No Longer Enrolling: 6/10/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04102579

A Parallel Group Double-Blind Randomized Placebo-Controlled Study to Evaluate the Efficacy and Safety of Eptinezumab Administered Intravenously in Subjects Experiencing an Acute Attack of Migraine


Protocol #19-1505, No Longer Enrolling: 3/28/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04152083

A Phase 3, Multi-center, Open-label, Safety Study of Oral Edaravone Administered over 48 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS)


Protocol #19-2377, No Longer Enrolling: 5/11/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04577404

A Prospective Study of Acute Flaccid Myelitis (AFM) to Define Natural History, Risk Factors, and Pathogenic Mechanisms


Protocol #19-2357, No Longer Enrolling: 2/15/2024
Locations: Childrens Hospital Colorado

Perceived Palliative Care Needs in Early-Onset Dementia


Protocol #19-2134, No Longer Enrolling: 4/6/2023
Locations: Outpatient CTRC, UCHealth Central Park Medical Center, University of Colorado Hospital

CLadribine Tablets: Collaborative Study to Evaluate the Impact On Central Nervous System BiomarKers in Multiple Sclerosis (CLOCK-MS)


Protocol #19-1980, No Longer Enrolling: 1/25/2022
Locations: Brain Imaging Center (BIC), Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03963375

A Phase 4 Multicenter Observational Study to Evaluate the Effectiveness of Patisiran in Patients with Polyneuropathy of Hereditary Transthyretin-Mediated (hATTR) Amyloidosis with a V122I or T60A Mutation


Protocol #19-3061, No Longer Enrolling: 7/28/2022
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04201418

Biomarker Development in LGMD 2i


Protocol #19-2943, No Longer Enrolling: 1/19/2023
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03981289

Feasibility of wearable eye tracking in dementia with Lewy bodies: A potential method of real-time detection of cognitive fluctuations


Protocol #20-0729, No Longer Enrolling: 5/5/2021
Locations: Brain Imaging Center (BIC), University of Colorado Hospital

An Open Label Extension Study of Ublituximab in Subjects with Relapsing Multiple Sclerosis


Protocol #19-2378, No Longer Enrolling: 7/9/2022
Locations: Brain Imaging Center (BIC), Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04130997

Platform Trial for the Treatment of Amyotrophic Lateral Sclerosis (ALS): A perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS.


Protocol #19-2645, No Longer Enrolling: 2/21/2024
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04297683

Phase 3b Open-Label, Multicenter, Safety Study of BIIB037 (aducanumab) in Subjects with Alzheimer's disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205


Protocol #20-0571, No Longer Enrolling: 5/7/2021
Locations: Brain Imaging Center (BIC), University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04241068

A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS)


Protocol #20-0404, No Longer Enrolling: 5/11/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04248465

Real-time Seizure identification with Unobtrusive Bio-potential Recording System


Protocol #19-2503, No Longer Enrolling: 5/5/2021
Locations: University of Colorado Hospital

AN OBSERVATIONAL STUDY OF OCRELIZUMAB TREATED PATIENTS WITH MULTIPLE SCLEROSIS TO DETERMINE THE INCIDENCE AND MORTALITY RATES OF BREAST CANCER AND ALL MALIGNANCIES (VERISMO STUDY)


Protocol #19-1600, No Longer Enrolling: 6/28/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT00000000

A MULTICENTER, LONGITUDINAL, OPEN-LABEL, SINGLE-ARM STUDY DESCRIBING COGNITIVE PROCESSING SPEED CHANGES IN RELAPSING MULTIPLE SCLEROSIS SUBJECTS TREATED WITH OZANIMOD (RPC-1063)


Protocol #19-2420, No Longer Enrolling: 10/18/2022
Locations: Brain Imaging Center (BIC), Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04140305

A Phase 1, Two-part, Open-label Dose-escalation and Double-blind, Placebo-controlled Dose-expansion Study with an Open-label Extension to Evaluate the Safety and Efficacy of ATA188 in Subjects with Progressive Multiple Sclerosis (ATA188-MS-101


Protocol #20-0454, No Longer Enrolling: 12/12/2023
Locations: Brain Imaging Center (BIC), Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03283826

ALS toolkit project


Protocol #20-0127, No Longer Enrolling: 3/17/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03489278

A Post-Market Study Evaluating the Safety of Infinity DBS System with MR Conditional Labeling


Protocol #19-1566, No Longer Enrolling: 5/4/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03884231

A Phase 2, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of TAK-079 in Patients With Generalized Myasthenia Gravis


Protocol #20-0609, No Longer Enrolling: 11/13/2021
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04159805

A Phase 2a, Multicenter, Randomized, Patient and Evaluator Blinded, Controlled Study Evaluating the Safety and Efficacy of NTX-001 Compared to Standard of Care in the Treatment of Acute Single Transected Peripheral Nerve Injury Occurring below the Distal Border of the Brachial Plexus Requiring Surgical Repair

NTX-001 is a single use surgical product intended for use in conjunction with standard suture neurorrhaphy of a severed nerves in patients between 16 and 65 years of age.
Protocol #20-1997, No Longer Enrolling: 10/9/2021
Locations: Denver Health and Hospital Authority, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04572906

Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS): Extension of the DISCOMS Study


Protocol #20-2772, No Longer Enrolling: 1/3/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04754542

A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patientreported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy (COMB157G23101)


Protocol #20-0705, No Longer Enrolling: 12/2/2022
Locations: Brain Imaging Center (BIC), Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04353492

A RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO-CONTROLLED PHASE 3 STUDY WITH OPEN-LABEL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF INEBILIZUMAB IN ADULTS WITH MYASTHENIA GRAVIS


Protocol #20-1787, No Longer Enrolling: 11/11/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04524273

Sleep assessed by actigraphy and direct recordings of the subthalamic nucleus in Parkinson's Disease.


Protocol #20-2508, No Longer Enrolling: 12/8/2023
Locations: Lone Tree Medical Center, University of Colorado Hospital

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PEGCETACOPLAN IN SUBJECTS WITH AMYOTROPHIC LATERAL SCLEROSIS (ALS)


Protocol #20-2005, No Longer Enrolling: 3/17/2022
Locations: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04579666

THE EVALUATION OF IMMUNE RESPONSES TO SARS-COV-2 MRNA VACCINES IN MULTIPLE SCLEROSIS PATIENTS ON OCRELIZUMAB


Protocol #21-3126, No Longer Enrolling: 12/6/2022
Locations: Outpatient CTRC, University of Colorado Hospital

A PHASE 3, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF RELDESEMTIV IN PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSIS (ALS)


Protocol #21-2598, No Longer Enrolling: 4/11/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04944784

A single-arm, prospective, multi-center, study to explore maintained efficacy with ofatumumab therapy in patients with relapsing Multiple Sclerosis who discontinue intravenously delivered anti-CD20 monoclonal antibody (aCD20 mAb) therapy (OLIKOS)


Protocol #20-2135, No Longer Enrolling: 8/4/2022
Locations: Brain Imaging Center (BIC), Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04486716

A Phase 3b, Multicenter, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oral Edaravone Administered for a Period of 48 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS)


Protocol #20-2340, No Longer Enrolling: 4/11/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04569084

Cerebrospinal fluid-biomarkers-based diagnostic and prognostic models for multiple sclerosis (SPINCOMS)


Protocol #20-1025, No Longer Enrolling: 10/22/2022
Locations: Brain Imaging Center (BIC), University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04496830

A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio?) in participants with relapsing forms of multiple sclerosis (GEMINI 1)


Protocol #20-1101, No Longer Enrolling: 7/2/2022
Locations: Brain Imaging Center (BIC), University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04410991

A Double-blind, Randomized, Placebo-controlled, Parallel-group Trial of the Efficacy and Safety of Nabiximols Oromucosal Spray as Add-on Therapy in Patients with Spasticity Due to Multiple Sclerosis


Protocol #20-0096, No Longer Enrolling: 11/11/2022
Locations: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04203498

Persistent Abnormal Cerebrovascular Reactivity and Vessel Wall Enhancement in Individuals Recovered from COVID-19 Infection


Protocol #21-2881, No Longer Enrolling: 1/14/2022
Locations: University of Colorado Hospital

AN OPEN-LABEL EXTENSION STUDY TO EVALUATE ROZANOLIXIZUMAB IN STUDY PARTICIPANTS WITH GENERALIZED MYASTHENIA GRAVIS


Protocol #20-2740, No Longer Enrolling: 6/24/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04650854

Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia Gravis


Protocol #21-3289, No Longer Enrolling: 5/26/2023
Locations: CTRC Inpatient, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04951622

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects with Generalized Myasthenia Gravis


Protocol #21-2746, No Longer Enrolling: 9/16/2021
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04115293

Evaluation of COVID-19 humoral and cellular immune response in immunosuppressed patients with autoimmune neurological conditions


Protocol #21-4092, No Longer Enrolling: 1/7/2023
Locations: Department Specific Free Standing Clinic, University of Colorado Hospital

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pitolisant on Excessive Daytime Sleepiness and Other Non-Muscular Symptoms in Patients with Myotonic Dystrophy Type 1, Followed by an Open-Label Extension


Protocol #21-3397, No Longer Enrolling: 10/20/2023
Locations: UCHealth Central Park Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04886518

Temporally Optimized Patterned Stimulation for use with Medtronic Activa DBS System.


Protocol #21-4042, No Longer Enrolling: 6/7/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04390867

Integrating Home-Based Video Teleneuropsychology into Clinical Practice: Typical Versus Atypical Alzheimer's Disease


Protocol #21-5037, No Longer Enrolling: 6/23/2023
Locations: Department Specific Free Standing Clinic, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05379023

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients with Amyotrophic Lateral Sclerosis (ALS)


Protocol #21-4249, No Longer Enrolling: 3/8/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05021536

A Comparative Study of Levodopa and Carbidopa Bioavailability Following Foslevodopa/foscarbidopa Infusion at Different Subcutaneous Sites in Parkinson's Disease Patients


Protocol #21-4448, No Longer Enrolling: 6/15/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05094050

Aneurysmal SubArachnoid Hemorrhage - Red Blood Cell Transfusion And Outcome (SAHaRA): A Randomized Controlled Trial


Protocol #21-4692, No Longer Enrolling: 11/14/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03309579

A Phase 2a Open-Label Preliminary Safety, Efficacy, and Biomarker Study of WP-0512 in Patients with Amyotrophic Lateral Sclerosis (ALS)


Protocol #21-4944, No Longer Enrolling: 11/9/2022
Locations: Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05218668

SAKURABONSAI: CLINICAL, IMAGING AND BIOMARKER OPEN-LABEL STUDY IN NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) WITH SATRALIZUMAB AS AN INTERVENTION


Protocol #21-4079, No Longer Enrolling: 6/15/2023
Locations: Brain Imaging Center (BIC), University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05269667

Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of SAR443820 in adult participants with amyotrophic lateral sclerosis, followed by an open-label extension


Protocol #22-0037, No Longer Enrolling: 6/2/2023
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05237284

An Investigator-initiated, Prospective, Multi-center, Controlled Feasibility Study of Direct Brain Recording and Stimulation for Memory Enhancement


Protocol #22-0332, No Longer Enrolling: 5/18/2023
Locations: Brain Imaging Center (BIC), University of Colorado Hospital

A Randomized, Double-Blind, Placebo-Controlled, Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple-Doses of AOC 1001 Administered Intravenously to Adult Myotonic Dystrophy Type 1 (DM1) Patients


Protocol #21-3032, No Longer Enrolling: 4/11/2023
Locations: Brain Imaging Center (BIC), CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05027269

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Range Finding Clinical Trial to Evaluate the Tolerability, Safety, and Efficacy of PRAX-944 in the Treatment of Adults with Essential Tremor


Protocol #22-0519, No Longer Enrolling: 10/21/2023
Locations: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05021991

A PHASE IV MULTICENTER, OPEN-LABEL STUDY EVALUATING B CELL LEVELS IN INFANTS POTENTIALLY EXPOSED TO OCRELIZUMAB DURING PREGNANCY - THE MINORE STUDY


Protocol #22-0386, No Longer Enrolling: 1/12/2024
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04998812

RNS System Responsive Thalamic Stimulation for Primary Generalized Seizures Study


Protocol #22-0838, No Longer Enrolling: 12/3/2022
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05147571

A Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled, 48-Week, Parallel-Group Study of the Efficacy and Safety of Losmapimod in Treating Patients with Facioscapulohumeral Muscular Dystrophy


Protocol #22-1143, No Longer Enrolling: 10/17/2023
Locations: Brain Imaging Center (BIC), Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05397470

A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study Assessing Safety, Tolerability, Pharmacodynamics, Efficacy, and Pharmacokinetics of DYNE-251 Administered to Participants with Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping

A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study Assessing Safety, Tolerability, Pharmacodynamics, Efficacy, and Pharmacokinetics of DYNE-251 Administered to Participants with Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping To evaluate the safety and tolerability of multiple IV doses of DYNE-251 administered to participants with DMD
Protocol #22-0022, No Longer Enrolling: 12/23/2022
Locations: Childrens Hospital Colorado

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of BIIB122/DNL151 in Participants with Parkinson's Disease and Pathogenic LRRK2 Variants


Protocol #22-1259, No Longer Enrolling: 6/7/2023
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05348785

A Phase 3b/4 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Verify the Clinical Benefit of Aducanumab (BIIB037) in Participants with Alzheimer's Disease


Protocol #22-0776, No Longer Enrolling: 2/1/2024
Locations: Brain Imaging Center (BIC), CU-RIC, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05310071

Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis


Protocol #22-1607, No Longer Enrolling: 1/13/2024
Locations: Brain Imaging Center (BIC), University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05054140

AUTOLOGOUS T-CELLS EXPRESSING A CHIMERIC ANTIGEN RECEPTOR DIRECTED TO B-CELL MATURATION ANTIGEN (BCMA) IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS (MG)


Protocol #21-5117, No Longer Enrolling: 11/10/2023
Locations: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04146051

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of ALXN2050 in Adult Participants with Generalized Myasthenia Gravis


Protocol #22-1813, No Longer Enrolling: 10/17/2023
Locations: Outpatient CTRC
More information available at ClinicalTrials.gov: NCT05218096

A Phase 1/2 Multiple-Ascending-Dose Study With a Long-Term Open-Label Extension to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Effect on Disease Progression of BIIB105 Administered Intrathecally to Adults With Amyotrophic Lateral Sclerosis With or Without Poly-CAG Expansion in the Ataxin-2 Gene


Protocol #22-2098, No Longer Enrolling: 11/11/2023
Locations: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04494256

A randomized, Double-blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-861 for the Treatment of Narcolepsy with Cataplexy (Narcolepsy Type 1)


Protocol #22-1789, No Longer Enrolling: 7/22/2023
Locations: CTRC Inpatient, Outpatient CTRC, UCHealth Central Park Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05687903

A Randomized, Double-blind, Placebo- controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-861 for the Treatment of Narcolepsy Without Cataplexy (Narcolepsy Type 2)


Protocol #22-2020, No Longer Enrolling: 7/22/2023
Locations: CTRC Inpatient, Outpatient CTRC, UCHealth Central Park Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05687916

CogMS: A real-world study into cognitive impairment in people with multiple sclerosis


Protocol #23-0547, No Longer Enrolling: 11/4/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05671055

RTOG 1008: A Randomized Phase II Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors

This is a clinical trial of cisplatin that will be administered by IV which is standard of care and radiation therapy that will be administered standard of care.
Protocol #13-2078, No Longer Enrolling: 3/10/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT01220583

RTOG 1304/NSABP B-51/Endorsed Study: A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy

This is a clinical trial of radiation that will be administered after a lumpectomy, to the breast and lymph nodes or mastectomy, to the area where the breast used to be and lymph nodes. This is done to see if giving radiation as described above will help women live longer.
Protocol #13-2454, No Longer Enrolling: 12/31/2020
Locations: Greeley Campus, Harmony Campus, Lone Tree Medical Center, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT01872975

PT-112-101 A Phase I, Open-Label, Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-122 Injection in Subjects with Advanced Solid Tumors

This is a clinical trial of PT-112 that will be administered injection which is investigational.
Protocol #14-0151, No Longer Enrolling: 3/11/2022
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02266745

E4512 A Randomized Phase III Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib Versus Observation for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

This is a double-blind clinical trial of Crizotinib(investigational) that will be administered orally.
Protocol #14-1915, No Longer Enrolling: 1/19/2024
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02201992

103A-301: A Multicenter, Double-blind, Placebo-controlled, Adaptive Phase 3 Trial of POL-103A Polyvalent Melanoma Vaccine in Post-resection Melanoma Patients with a High Risk of Recurrence

This is a clinical trial of investigational drug POL-103A, which will be administered by injections (shots).
Protocol #12-1076, No Longer Enrolling: 8/20/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT01546571

Pilot Project to Evaluate Hyperglycemia and Glucose Variability in Cancer Patients Receiving Dexamethasone


Protocol #14-1764, No Longer Enrolling: 1/29/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02372539

NRG-BR002 A Phase IIR/III Trial of Standard of Care Therapy with or without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast Cancer

This is a clinical trial of standard of care and SBRT that will be administered by radiotherapy and is investigational.
Protocol #15-0136, No Longer Enrolling: 10/1/2019
Locations: Greeley Hospital, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02364557

Perioperative Therapy for Resectable and Borderline Resectable Pancreatic Adenocarcinoma with Molecular Correlates


Protocol #15-0150, No Longer Enrolling: 6/8/2021
Locations: Dana Farber Cancer Institute, Lone Tree Medical Center, Mayo Clinic, Arizona, New York University, University of Arizona Cancer Center, University of Colorado Hospital, University of Kansas Cancer Center
More information available at ClinicalTrials.gov: NCT02723331

ML28897/PRO 02 MY PATHWAY: An Open-Label Phase IIA Study Evaluating Trastuzumab/Pertuzumab, Erlotinib, Vemurafenib/Cobimetinib, Vismodegib, Alectinib, and Atezolizumab in Patients who have Advanced Solid Tumors with Mutations or Gene Expression Abnormalities Predictive of Response to One of these Agents


Protocol #15-0801, No Longer Enrolling: 9/4/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02091141

EAY131 Molecular Analysis for Therapy Choice (MATCH)


Protocol #15-1111, No Longer Enrolling: 11/4/2022
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02465060

AEWS1221 Randomized Phase II Trial Evaluating the Addition of the IGF-1R Monoclonal Antibody Ganitumab (AMG 479, NSC# 75008, IND# 120449) to Multiagent Chemotherapy for Patients with Newly Diagnosed Metastatic Ewing Sarcoma


Protocol #15-1618, No Longer Enrolling: 5/22/2020
More information available at ClinicalTrials.gov: NCT02306161

RXDX-101-02 An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients with Locally Advanced or Metastatic Solid Tumors that Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangement


Protocol #15-1574, No Longer Enrolling: 1/8/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02568267

EZH-102 A Phase I Study of the EZH2 Inhibitor Tazemetostat in Pediatric Subjects with Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma


Protocol #15-1825, No Longer Enrolling: 6/29/2021
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02601937

MLN0128 A Phase Ib Study of the Combination of MLN0128 (Dual TORC I/2 Inhibitor) and MLN8237 (Aurora A Inhibitor, Alisertib) in Patients with Advanced Solid Tumors with an Expansion Cohort in Metastatic Triple-Negative Breast Cancer (TNBC)


Protocol #15-1135, No Longer Enrolling: 3/19/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02719691

JoLT-Ca A Randomized Phase III Study of Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) in High Risk Patients with Stage I Non-Small Cell Lung Cancer (NSCLC)


Protocol #15-1894, No Longer Enrolling: 4/1/2022
Locations: Lone Tree Medical Center, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02468024

RU2413061 Randomized, Double-Blind, Phase II Study of Radioactive Iodine (RAI) in Combination with Placebo or Selumetinib for the Treatment of RAI-Avid Recurrent/Metastatic Thyroid Cancers


Protocol #15-1932, No Longer Enrolling: 2/26/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02393690

I5B-MC-JGDL A Phase 1b (Open-Label)/Phase 2 (Randomized, Double-Blinded) Study evaluating Gemcitabine and Docetaxel With or Without Olaratumab in the Treatment of Advanced Soft Tissue Sarcoma


Protocol #15-1995, No Longer Enrolling: 11/27/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02659020

MK-3475-158-00 A Clinical Trial of Pembrolizumab (MK-3475) Evaluating Predictive Biomarkers in Subjects with Advanced Solid Tumors


Protocol #15-2301, No Longer Enrolling: 11/8/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02628067

AP32788-15-101 A Phase I/2 Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of the Oral EGFR/HER2 Inhibitor TAK-788 (AP32788) in Non-Small Cell Lung Cancer

1. To determine the safety profile of orally administered AP32788 2. To identify the RP2D, dose-limiting toxicities (DLTs), and the maximum tolerated dose (MTD) of AP32788 3 .To determine the pharmacokinetic (PK) profile of AP32788 and its active metabolites, AP32960 and AP32914 4. To evaluate the anti-tumor activity of AP32788 in NSCLC patients with EGFR or HER2 mutations 5. To explore associations between tumor and plasma biomarkers and AP32788 efficacy and safety
Protocol #16-0208, No Longer Enrolling: 2/14/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02716116

ANHL12P1 A Randomized Phase II Trial of Brentuximab Vedotin (SGN35, NSC# 749710) or Crizotinib (NSC# 749005, commercially labeled) in Combination with Chemotherapy for Newly Diagnosed Patients with Anaplastic Large Cell Lymphoma (ALCL) IND#117117


Protocol #15-1921, No Longer Enrolling: 9/14/2021
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT01979536

INTense Exercise foR surviVAL among Men with Metastatic Prostate Cancer (INTERVAL GAP4): A Multicenter, Randomised, Controlled Phase III Study

A comparison of exercise versus no exercise in men with Metastatic Castrate-Resistant Prostate Cancer.
Protocol #16-0227, No Longer Enrolling: 10/1/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02730338

D419NC00001 A Phase 1/2 Study of Durvalumab and Monalizumab in Adult Subjects with Select Advanced Solid Tumors


Protocol #16-0207, No Longer Enrolling: 7/31/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02671435

NRG-GY006: A Randomized Phase III Trial of Radiation Therapy and Cisplatin Alone or in Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer


Protocol #16-0493, No Longer Enrolling: 8/13/2021
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02466971

LCCC 1523: Phase 2 Trial of Brigatinib after Treatment with Next-Generation ALK inhibitors in Refractory ALK Rearranged NSCLC


Protocol #16-0506, No Longer Enrolling: 9/30/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02706626

KCP-9274-901 A Phase 1 Open-label Study of the Safety, Tolerability and Efficacy of KPT-9274, a Dual Inhibitor of PAK4 and NAMPT, in Patients with Advanced Solid Malignancies or Non-Hodgkin's Lymphoma


Protocol #16-0628, No Longer Enrolling: 7/10/2020
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02702492

AAML1531 Risk-stratified Therapy for Acute Myeloid Leukemia in Down Syndrome


Protocol #16-0709, No Longer Enrolling: 4/20/2022
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02521493

NRG-GY005: A Randomized Phase II/III Study of the Combination of Cediranib and Olaparib Compared to Cediranib or Olaparib Alone, or Standard of Care Chemotherapy in Women with Recurrent Platinum-Resistant or -Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (COCOS)


Protocol #16-0708, No Longer Enrolling: 10/6/2020
Locations: Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02502266

A Phase I/II, Open-Label, Dose-Escalation and Expansion Study of Entrectinib (RXDX-101) in Pediatrics with Locally Advanced or Metastatic Solid or Primary CNS Tumors and/or who Have No Satisfactory Treatment Options


Protocol #16-0749, No Longer Enrolling: 5/12/2022
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02650401

Molecular Profiling-based Assignment of Cancer Therapy for Patients with Advanced Solid Tumors (MPACT)


Protocol #16-1057, No Longer Enrolling: 7/15/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT01827384

A Phase 2 Study of Grape Seed Extract (GSE) Product in Asymptomatic or Minimally Symptomatic Non-Metastatic Prostate Cancer Patients with Rising PSA

The objective is to study the effects of GSE (Grape Seed Extract) on patients with Prostate cancer
Protocol #16-0607, No Longer Enrolling: 6/8/2023
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03087903

Randomized Phase II trial of preoperative fulvestrant with or without enzalutamide in ER+/Her2- breast cancer


Protocol #16-1042, No Longer Enrolling: 9/9/2021
Locations: Highlands Ranch Hospital, Lone Tree Medical Center, Memorial Sloan Kettering Cancer Center, University of Colorado Hospital, West Cancer Center
More information available at ClinicalTrials.gov: NCT02955394

MAINTENANCE OBINUTUZUMAB FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA COMPLETE OR PARTIAL RESPONDERS


Protocol #16-1217, No Longer Enrolling: 8/5/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02498951

A Phase 1b Study of Navicixizumab (OMP-305B83) plus Weekly Paclitaxel in Subjects with Platinum Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancer


Protocol #16-1225, No Longer Enrolling: 11/12/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03030287

EA5142 Adjuvant Nivolumab in Resected Lung Cancers (ANVIL) A Randomized Phase III Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-Small Cell Lung Cancers


Protocol #16-1241, No Longer Enrolling: 10/4/2019
Locations: Greeley Hospital, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02595944

Phase l-ll Study of MEK 162 for Children with Low-Grade Gliomas and Other Ras/Raf/ERK Pathway Activated Tumors


Protocol #16-1205, No Longer Enrolling: 12/17/2020
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02285439

A Phase 2 Efficacy and Safety Study of Niraparib in Men with Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies

To establish safety and efficacy of Niraparib in patients with targeted DNA- repair anomalies
Protocol #16-1470, No Longer Enrolling: 4/9/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02854436

A Phase 2, Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

A rollover study to continue to document patients previously enrolled to an enzalutamide study
Protocol #16-1640, No Longer Enrolling: 5/28/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02960022

PHASE 2 STUDY OF ALISERTIB AS A SINGLE AGENT IN RECURRENT OR PROGRESSIVE CENTRAL NERVOUS SYSTEM (CNS) ATYPICAL TERATOID RHABDOID TUMORS (AT/RT) AND EXTRA-CNS MALIGNANT RHABDOID TUMORS (MRT) AND IN COMBINATION THERAPY IN NEWLY DIAGNOSED AT/RT (SJATRT)


Protocol #15-1302, No Longer Enrolling: 6/16/2023
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02114229

Aflac ST 1501: Abemaciclib in Children with Newly Diagnosed Diffuse Intrinsic Pontine Glioma, and in Children with Recurrent and Refractory Solid Tumors Including Malignant Brain Tumors


Protocol #16-1825, No Longer Enrolling: 8/7/2020
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02644460

A Randomized Phase 2 Trial of Cisplatin/Gemcitabine with or without M6620 (VX-970) in Metastatic Urothelial Carcinoma

A comparison of Gem/Cis +/- VX-970
Protocol #16-1951, No Longer Enrolling: 12/31/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02567409

A Phase 2 Study of the JAK1/JAK2 Inhibitor Ruxolitinib With Chemotherapy in Children With De Novo High-Risk CRLF2-Rearranged and/or JAK Pathway Mutant Acute Lymphoblastic Leukemia


Protocol #16-1970, No Longer Enrolling: 2/1/2023
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02723994

A PHASE III, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY OF ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY) AS ADJUVANT THERAPY IN PATIENTS WITH RENAL CELL CARCINOMA AT HIGH RISK OF DEVELOPING METASTASIS FOLLOWING NEPHRECTOMY

Atezolizumab vs. placebo as adjuvant therapy post nephrectomy
Protocol #16-1420, No Longer Enrolling: 10/28/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03024996

ADVL1414: A PHASE 1 STUDY OF SELINEXOR (KPT-330, IND #125052), A SELECTIVE XPO1 INHIBITOR, IN RECURRENT AND REFRACTORY PEDIATRIC SOLID TUMORS, INCLUDING CNS TUMORS


Protocol #15-1936, No Longer Enrolling: 3/17/2022
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02323880

Is disruption of the human gut microbial environment associated with cognitive impairment following chemotherapy for breast cancer?


Protocol #16-2138, No Longer Enrolling: 9/12/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT00000000

An Open-Label Study of Brentuximab Vedotin+Adriamycin, Vinblastine, and Dacarbazine in Pediatric Patients With Advanced Stage Newly Diagnosed Hodgkin Lymphoma


Protocol #16-2269, No Longer Enrolling: 2/9/2021
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02979522

ARM Study: A phase II trial to evaluate crizotinib in the neoadjuvant setting in non-small cell lung cancer patients with surgically resectable, ALK, ROS1, or MET-oncogene positive non-small cell lung cancer


Protocol #16-2025, No Longer Enrolling: 9/23/2020
Locations: Lone Tree Medical Center, University of California San Francisco, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03088930

Combination Targeted Therapy with Pembrolizumab and Lenvatinib in Progressive, Radioiodine-Refractory Differentiated Thyroid Cancers: A Phase II Study


Protocol #16-2230, No Longer Enrolling: 3/31/2020
Locations: Dana Farber Cancer Institute, MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, The Ohio State University Comprehensive Cancer Center, UCLA, Jonsson Cancer Center, University of Colorado Hospital, University of Michigan Comprehensive Cancer Center
More information available at ClinicalTrials.gov: NCT02973997

Phase I/II Study of Pembrolizumab and Cabozantinib in Patients with Metastatic Renal Cell Carcinoma

To assess the efficacy of Prmbrolizumab plus Cabozantinib in patients with metastatic renal cell carcinoma
Protocol #16-2300, No Longer Enrolling: 12/19/2020
Locations: Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03149822

CRIZOTINIB (XALKORI) EXPANDED ACCESS PROTOCOL FOR THE TREATMENT OF ADULT OR PEDIATRIC PATIENTS WITH SOLID OR HEMATOLOGIC MALIGNANCIES THAT HARBOR A CRIZOTINIB-SENSITIVE MOLECULAR ALTERATION BUT WHO ARE UNABLE TO SWALLOW CRIZOTINIB CAPSULES


Protocol #16-2544, No Longer Enrolling: 7/28/2023
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02473497

CA018003: A Phase 2, Fast Real-time Assessment of Combination Therapies in Immuno-ONcology Study in Participants with Advanced Gastric Cancer (FRACTION-Gastric Cancer)


Protocol #16-2449, No Longer Enrolling: 4/27/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02935634

A PHASE 1, DOSE ESCALATION STUDY OF ALX148 IN PATIENTS WITH ADVANCED SOLID TUMORS AND LYMPHOMA


Protocol #16-2248, No Longer Enrolling: 2/24/2021
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03013218

A Multi-Center, Open label, Dose Escalation, Phase I/Ib Study to Evaluate the Safety and Efficacy of RP4010, a Calcium Release Activated Calcium (CRAC) Channel Inhibitor, in Patients with Relapsed or Refractory Lymphomas


Protocol #17-0029, No Longer Enrolling: 10/1/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03119467

A PHASE 2 STUDY OF REGN2810, A FULLY HUMAN MONOCLONAL ANTIBODY TO PROGRAMMED DEATH-1, IN PATIENTS WITH ADVANCED BASAL CELL CARCINOMA WHO EXPERIENCED PROGRESSION OF DISEASE ON HEDGEHOG PATHWAY INHIBITOR THERAPY, OR WERE INTOLERANT OF PRIOR HEDGEHOG PATHWAY INHIBITOR THERAPY


Protocol #16-2696, No Longer Enrolling: 12/24/2020
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03132636

A Multicenter Phase 1, Open-Label Study of DCC-3014 to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Patients with Advanced Tumors


Protocol #16-2407, No Longer Enrolling: 4/11/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03069469

A Phase I/II, Open-Label, Multicenter, Dose Escalation and Efficacy Study of mRNA-2416, a Lipid Nanoparticle Encapsulated mRNA Encoding Human OX40L, for Intratumoral Injection to Patients with Advanced Malignancies


Protocol #17-0074, No Longer Enrolling: 7/2/2021
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03323398

S1609, DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors


Protocol #17-0280, No Longer Enrolling: 10/23/2020
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02834013

NRG-GU002, PHASE II-III TRIAL OF ADJUVANT RADIOTHERAPY AND ANDROGEN DEPRIVATION FOLLOWING RADICAL PROSTATECTOMY WITH OR WITHOUT ADJUVANT DOCETAXEL

A comparison of adjuvant radiotherapy + androgen therapy after a radical prostatectomy with and without Docetaxel.
Protocol #17-0266, No Longer Enrolling: 9/7/2022
Locations: Broomfield Hospital, Grandview Hospital, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Long's Peak Hospital, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Pikes Peak Regional Hospital, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03070886

Lenalidomide and Dexamethasone (Rd) versus Clarithromycin (Biaxin) /Lenalidomide (Revlimid) / Dexamethasone (BiRd) as Initial Therapy in Multiple Myeloma


Protocol #17-7836, No Longer Enrolling: 12/17/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02516696

EA8143: A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)

A comparison of Nivolumab vs no Nivolumab prior to nephrectomy.
Protocol #17-0406, No Longer Enrolling: 11/25/2020
Locations: Greeley Campus, Harmony Campus, Lone Tree Medical Center, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03055013

A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAB001 in Subjects with Advanced Malignancies


Protocol #17-0402, No Longer Enrolling: 9/11/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03474640

Phase 1 trial of ZW25 in patients with locally advanced (unresectable) and/or metastatic HER2-expressing cancers


Protocol #17-0512, No Longer Enrolling: 3/2/2022
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02892123

NANT 2015-02: PHASE 1 STUDY OF LORLATINIB (PF-06463922), AN ORAL SMALL MOLECULE INHIBITOR OF ALK/ROS1, FOR PATIENTS WITH ALK-DRIVEN RELAPSED OR REFRACTORY NEUROBLASTOMA


Protocol #17-0511, No Longer Enrolling: 4/21/2023
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03107988

A PHASE 1/2, OPEN-LABEL, MULTICENTER STUDY OF THE COMBINATION OF NKTR-214 AND NIVOLUMAB OR THE COMBINATION OF NKTR-214, NIVOLUMAB, AND OTHER ANTI-CANCER THERAPIES IN PATIENTS WITH SELECT LOCALLY ADVANCED OR METASTATIC SOLID TUMOR MALIGNANCIES


Protocol #17-0491, No Longer Enrolling: 2/7/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02983045

EA2161: A Phase II Study of MLN0128 (TAK-228) in Rapalog-Resistant Advanced Pancreatic Neuroendocrine Tumors (PNET)


Protocol #17-0614, No Longer Enrolling: 1/3/2020
Locations: Greeley Hospital, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02893930

A PHASE Ib/II STUDY EVALUATING THE SAFETY AND EFFICACY OF OBINUTUZUMAB IN COMBINATION WITH IDASANUTLIN AND ENETOCLAX IN PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA AND OBINUTUZUMAB OR RITUXIMAB IN COMBINATION WITH IDASANUTLIN AND VENETOCLAX IN PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA


Protocol #17-0173, No Longer Enrolling: 10/1/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03135262

CA209744: Risk-based, response-adapted, Phase II open-label trial of nivolumab + brentuximab vedotin (N + Bv) for children, adolescents, and young adults with relapsed/refractory (R/R) CD30 + classic Hodgkin lymphoma (cHL) after failure of first-line therapy, followed by brentuximab + bendamustine (Bv + B) for participants with a suboptimal response.


Protocol #17-0401, No Longer Enrolling: 7/10/2021
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02927769

NRG-LU002: Maintenance Systemic Therapy Versus Local Consolidative Therapy (LCT) Plus Maintenance Systemic Therapy for Limited Metastatic Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II/III Trial


Protocol #17-0828, No Longer Enrolling: 5/14/2020
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital
More information available at ClinicalTrials.gov: NCT03137771

A Phase 1, Open-Label, Dose-Escalation and Cohort Expansion First-in-Human Study of the Safety, Tolerability, Activity and Pharmacokinetics of REGN3767 (anti-LAG-3 mAb) Administered Alone or in Combination with REGN2810 (anti-PD-1 mAb) in Patients with Advanced Malignancies


Protocol #17-0500, No Longer Enrolling: 6/17/2022
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03005782

A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-022, an anti-TIM-3 Monoclonal Antibody, in Patients with Advanced Solid Tumors


Protocol #17-0767, No Longer Enrolling: 10/25/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02817633

A Phase I Trial of MK-7684 as Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors


Protocol #17-0948, No Longer Enrolling: 5/19/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02964013

A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared with Investigator's Choice in HLA-A*0201 Positive Patients with Previously Untreated Advanced Uveal Melanoma


Protocol #17-0996, No Longer Enrolling: 12/29/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03070392

A Phase 3, Randomized, Open-Label Study of Nivolumab Combined with Cabozantinib versus Sunitinib in Participants with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma. Version Amendment 1 v2.0 dated 12/18/17

A comparison of Nivolumab + cabozantinib vs Nivolumab + Ipilimumab + Cabozantinib vs Sunitinb in patients with kidney cancer
Protocol #17-1121, No Longer Enrolling: 10/17/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03141177

Phase I Trial of Arsenic Trioxide with Cyclophosphamide in Patients with Relapsed/Refractory Acute Myeloid Leukemia


Protocol #17-0754, No Longer Enrolling: 1/16/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03318016

A Phase 1b/2 Study of BMS-813160 in Combination with Chemotherapy or Nivolumab in Patients with Advanced Solid Tumors


Protocol #17-1167, No Longer Enrolling: 2/8/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03184870

A Phase IA/IB Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of RO7198457 as a Single Agent and in Combination with Atezolizumab in Patients with Locally Advanced or Metastatic Tumors


Protocol #17-0991, No Longer Enrolling: 3/2/2022
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03289962

ADVL1622: Phase 2 Trial of XL184 (Cabozantinib) an Oral Small-Molecule Inhibitor of Multiple Kinases, in Children and Young Adults with Refractory Sarcomas, Wilms Tumor, and Other Rare Tumors


Protocol #17-1045, No Longer Enrolling: 10/27/2020
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02867592

Azacitidine and Venetoclax (ABT-199) as Induction Therapy with Venetoclax Maintenance in Previously Untreated Elderly Patients with Acute Myeloid Leukemia


Protocol #17-7821, No Longer Enrolling: 2/6/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03466294

A Phase 1/1b/2a, 3-Part, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Ascending Doses of AZD5991 Monotherapy and in Combination with Venetoclax in Subjects with Relapsed or Refractory Haematologic Malignancies


Protocol #17-0900, No Longer Enrolling: 3/28/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03218683

AALL1621: A Phase 2 Study of Inotuzumab Ozogamicin (NSC# 772518, IND#TBD) in Children and Young Adults with Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL)


Protocol #17-1086, No Longer Enrolling: 1/27/2024
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02981628

A Phase I Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients with Relapsed or Refractory Malignancies (M13-833)


Protocol #17-0564, No Longer Enrolling: 6/16/2023
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03236857

E7080-A001-216: A Phase 1/2 Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including CNS Tumors


Protocol #17-1165, No Longer Enrolling: 5/28/2022
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03245151

A Phase I Study of Stereotactic Body Radiation Therapy for Patients with Limited Locoregional Recurrences of Ovarian and Uterine Serous Carcinoma


Protocol #17-1333, No Longer Enrolling: 10/8/2020
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03325634

AGCT1531: A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors


Protocol #17-1043, No Longer Enrolling: 1/24/2024
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03067181

Anal Cancer/HSIL Outcomes Research (ANCHOR) Study


Protocol #15-1466, No Longer Enrolling: 3/18/2022
Locations: Denver Health and Hospital Authority, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02135419

PROSPECTIVE, LONGITUDINAL, NON-INTERVENTIONAL STUDY OF DISEASE BURDEN AND TREATMENT OF PATIENTS WITH LOW-RISK MYELOFIBROSIS (MF) OR HIGH-RISK ESSENTIAL THROMBOCYTHEMIA (ET) OR ET PATIENTS RECEIVING ET-DIRECTED THERAPY


Protocol #17-6155, No Longer Enrolling: 7/8/2021
Locations: Memorial Hospital Central
More information available at ClinicalTrials.gov: NCT02953704

CANscript Clinical outcomEs in a Real-world Setting (ANCERS)-2: A prospective, multicenter, observational study examining the clinical utility of CANscript in routine clinical practice


Protocol #17-0694, No Longer Enrolling: 11/14/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03253575

A study of enfortumab vedotin (ASG-22CE) as monotherapy or in combination with other anticancer therapies for the treatment of urothelial cancer

To evaluate the use of Enfortumab vedotin plus CPI in treatment of advanced bladder cancer
Protocol #17-1410, No Longer Enrolling: 10/25/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03288545

ADVL1514: A Phase I Study of ABI-009 (Nab-Rapamycin) in Pediatric Patients With Recurrent or Refractory Solid Tumors, Including CNS Tumors as a Single Agent and in Combination with Temozolomide and Irinotecan


Protocol #17-1376, No Longer Enrolling: 8/19/2021
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02975882

A Phase I, Open-Label, Multicenter Study of the Safety and Efficacy of MIW815 (ADU-S100) Administered by Intratumoral Injection to Patients with Advanced/Metastatic Solid Tumors or Lymphomas


Protocol #17-1452, No Longer Enrolling: 12/14/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02675439

An International, Multi-Center, Open-Label, Randomized, Phase III Trial of Sacituzumab Govitecan versus Treatment of Physician Choice in Patients with Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments


Protocol #17-1501, No Longer Enrolling: 10/28/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02574455

A Phase 2, Multicenter Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Treatment of Patients with Metastatic Melanoma


Protocol #17-1474, No Longer Enrolling: 2/9/2021
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02360579

A Phase 1b Multi-cohort Study of the Combination of Pembrolizumab (MK-3475) plus Binimetinib alone or the Combination of Pembrolizumab plus Chemotherapy with or without Binimetinib in Participants with Metastatic Colorectal Cancer (KEYNOTE-651)


Protocol #17-1021, No Longer Enrolling: 9/16/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03374254

A Phase I/Ib Study of sEphB4-HSA in Combination with Chemotherapy or Cetuximab and Radiation Therapy in Patients with Intermediate to High Risk, Locally-Advanced Squamous Cell Carcinomas of the Head and Neck


Protocol #16-2575, No Longer Enrolling: 6/23/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04091867

A non-randomized, open-label, multi-center, Phase I/II study of PI3K inhibitor copanlisib in pediatric patients with relapsed/refractory solid tumors or lymphoma (BAY 80-6946 /19176)


Protocol #17-1495, No Longer Enrolling: 1/28/2023
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03458728

PBTC-029: A Phase I and Phase II Re-Treatment Study of AZD6244 for Recurrent or Refractory Pediatric Low Grade Glioma


Protocol #17-1790, No Longer Enrolling: 1/8/2021
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT01089101

Phase II open-label global study to evaluate the effect of dabrafenib in combination with trametinib in children and adolescent patients with BRAF V600 mutation positive Low Grade Glioma (LGG) or relapsed or refractory High Grade Glioma (HGG)


Protocol #17-1406, No Longer Enrolling: 4/21/2021
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02684058

TACL 2016-003: Epigenetic Reprogramming in Relapse AML: A Phase I Study of Decitabine and Vorinostat Followed by Fludarabine, Cytarabine and G-CSF (FLAG) in Children and Young Adults with Relapsed/Refractory AML


Protocol #17-1777, No Longer Enrolling: 7/10/2020
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03263936

A Phase II Study of TAK-228 in patients with previously treated metastatic renal cell carcinoma

Assessment of TAK 228 in metastatic kidney cancer
Protocol #17-0727, No Longer Enrolling: 2/12/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03097328

COG AALL15P1 - A Groupwide Pilot Study to Test the Tolerability and Biologic Activity of the Addition of Azacitidine (IND# 133688, NSC# 102816) to Chemotherapy in Infants with Acute Lymphoblastic Leukemia (ALL) and KMT2A (MLL) Gene Rearrangement


Protocol #17-0619, No Longer Enrolling: 6/24/2020
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02828358

S1616, A Phase II Randomized Study of Nivolumab (NSC-748726) with Ipilimumab (NSC-732442) OR Ipilimumab Alone in Advanced Melanoma Patients Refractory to an Anti-PD-1 or Anti-PD-L1 Agent


Protocol #17-1834, No Longer Enrolling: 8/13/2020
Locations: Greeley Campus, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital
More information available at ClinicalTrials.gov: NCT03033576

A Multiarm, Open-label, Multicenter, Phase 1b/2 Study to Evaluate Novel Combination Therapies in Subjects with Previously Treated Advanced EGFRm NSCLC


Protocol #17-1757, No Longer Enrolling: 6/6/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03381274

An Open-Label, Non-Randomized, Multicenter Study to Determine the Pharmacokinetics and Safety of Niraparib Following A Single Oral Dose in Patients with Advanced Solid Tumors and Either Normal Hepatic Function or Moderate Hepatic Impairment


Protocol #17-1943, No Longer Enrolling: 7/10/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03359850

PD-1 Immune Checkpoint Inhibition for the Reversal of Squamous Dysplasia in High Risk Current and Former Smokers with or without a History a Lung Cancer

Subjects will receive treatment with nivolumab as a 30 minute IV infusion on Day 1 of a treatment cycle every two weeks (14 days). There will be no dose escalations or reductions allowed. Treatment may be delayed for up to a maximum of 2 weeks from the scheduled re-treatment date. Subjects may be dosed no less than 12 days from the previous dose.
Protocol #17-1492, No Longer Enrolling: 11/17/2021
Locations: Rocky Mountain Regional VA Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03347838

Open-label, Randomized, Controlled, Phase 3 Safety and Efficacy Study of Trans Sodium Crocetinate (TSC) with Radiation Therapy and Temozolomide in Newly Diagnosed Glioblastoma (GBM) Biopsy-Only Subjects


Protocol #17-1974, No Longer Enrolling: 12/11/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03393000

TACL 2016-001: A Randomized, Open-label, Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Patients With Relapsed or Refractory Mature B-cell non-Hodgkin Lymphoma


Protocol #17-1481, No Longer Enrolling: 8/15/2020
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02703272

An Open-Label Phase 2 Study of Itacitinib (INCB039110) in Combination With Low-Dose Ruxolitinib or Itacitinib Alone Following Ruxolitinib in Subjects With Myelofibrosis


Protocol #17-2086, No Longer Enrolling: 2/26/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03144687

A Phase 1/2 Study of the Highly-selective RET Inhibitor, BLU-667, in Patients with Thyroid Cancer, Non-Small Cell Lung Cancer (NSCLC) and Other Advanced Solid Tumors


Protocol #17-1808, No Longer Enrolling: 1/4/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03037385

A021502: Randomized Trial of Standard Chemotherapy Alone or Combined with Atezolizumab as Adjuvant Therapy for Patients with Stage III Colon Cancer and Deficient DNA Mismatch Repair


Protocol #17-2036, No Longer Enrolling: 1/21/2023
Locations: Cherry Creek Medical Center, Greeley Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02912559

ARST1431 - A Randomized Phase 3 Study of Vincristine, Dactinomycin, Cyclophosphamide (VAC) Alternating with Vincristine and Irinotecan (VI) Versus VAC/VI Plus Temsirolimus (TORI, Torisel, NSC# 683864, IND# 122782) in Patients with Intermediate Risk (IR) Rhabdomyosarcoma (RMS)


Protocol #17-1992, No Longer Enrolling: 4/25/2023
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02567435

Identifying Biomarkers of Immune-Related Toxicity in Cancer Patients Treated with Immune Checkpoint Inhibitors; A Pilot Project


Protocol #17-1940, No Longer Enrolling: 12/6/2019
Locations: Rocky Mountain Regional VA Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03409016

S1613: A RANDOMIZED PHASE II STUDY OF TRASTUZUMAB AND PERTUZUMAB (TP) COMPARED TO CETUXIMAB AND IRINOTECAN (CETIRI) IN ADVANCED/METASTATIC COLORECTAL CANCER (MCRC) WITH HER-2 AMPLIFICATION


Protocol #17-2125, No Longer Enrolling: 8/11/2021
Locations: Greeley Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03365882

A Pilot, Open-Label, Multi-Center, Multi-Dose Study of GRN-1201 Added to Pembrolizumab in Subjects with Non-Small Cell Lung Cancer with High PD-L1 Expression


Protocol #17-1778, No Longer Enrolling: 5/13/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03417882

Open label, Phase I/II study to evaluate pharmacokinetics, pharmacodynamics, safety, and anticancer activity of avelumab in pediatric subjects from birth to less than 18 years of age with refractory or relapsed solid tumors and lymphoma (Merck-Serono Protocol MS100070-0306


Protocol #17-1845, No Longer Enrolling: 8/27/2020
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03451825

A Phase 1/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination with Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558)in Advanced Solid Tumors.


Protocol #17-2164, No Longer Enrolling: 8/4/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT01968109

A Phase I Study of the Wee 1 kinase (Wee 1) inhibitor AZD1775 in combination with Radiotherapy and Cisplatin in Cervical, Upper Vaginal and Uterine Cancers (10041848, 10008224, 10008238, 10046888, 10014735)


Protocol #17-2198, No Longer Enrolling: 7/21/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03345784

A Phase 1b/2 Open-Label, Dose Escalation and Expansion Study of Orally Administered VRx-3996 and Valganciclovir in Subjects with Epstein-Barr Virus-Associated Lymphoid Malignancies

Determine the safety and tolerability of VRx-3996/valganciclovir. Evaluate the impact of parameters of HIV infection (e.g., CD4 cell counts, HIVqPCR) on safety and efficacy. And Evaluate the impact of VRx-3996/valganciclovir on replication of non-Alpha herpesviruses.
Protocol #17-2074, No Longer Enrolling: 6/22/2022
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03397706

A Phase 2 Study of Cabiralizumab (BMS-986227, FPA008) Administered in Combination with Nivolumab (BMS-936558) with and without Chemotherapy in Patients with Advanced Pancreatic Cancer


Protocol #17-2189, No Longer Enrolling: 3/28/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03336216

PBTC-039: Phase II study of Peginterferon alfa-2b (SYLATRON) for pediatric patients with unresectable or recurrent craniopharyngioma


Protocol #17-2257, No Longer Enrolling: 11/18/2020
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT01964300

A Phase 1/2 Dose Escalation and Dose Expansion Study of BA3011 Alone and in Combination with Nivolumab in Adult and Adolescent Patients 12 Years and Older in Patients with Advanced Solid Tumors


Protocol #17-2450, No Longer Enrolling: 8/21/2020
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03425279

A PHASE 1B, OPEN LABEL, MULTI-CENTER TRIAL OF AB-110 IN ADULTS WITH HEMATOLOGIC MALIGNANCIES UNDERGOING CORD BLOOD TRANSPLANTATION

A PHASE 1B, OPEN LABEL, MULTI-CENTER TRIAL OF AB-110 IN ADULTS WITH HEMATOLOGIC MALIGNANCIES UNDERGOING CORD BLOOD TRANSPLANTATION To assess the safety of infusing AB-110, cord blood (CB) hematopoietic stem and progenitor cells (HSPCs) with engineered human umbilical vein endothelial cells.
Protocol #17-2078, No Longer Enrolling: 7/15/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03483324

A Phase I Trial of AZD9291 and Necitumumab in EGFR-Mutant Non-Small Cell Lung Cancer After Progression on a Previous EGFR Tyrosine Kinase Inhibitor


Protocol #17-2381, No Longer Enrolling: 10/9/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02496663

An Open-Label, Dose Escalation, Phase 1, First-in-Human Study of TAK-164, an Antibody-Drug Conjugate, in Patients with Advanced Gastrointestinal Cancers Expressing Guanylyl Cyclase C


Protocol #17-2226, No Longer Enrolling: 3/19/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03449030

First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of Axl-specific antibody-drug conjugate (enapotamab vedotin, HuMax-AXL-ADC) in patients with solid tumors


Protocol #17-2451, No Longer Enrolling: 9/4/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02988817

A Phase 1/2 First-in-human Study of BMS-986258 Alone and in Combination with Nivolumab in Advanced Malignant Tumors


Protocol #18-0031, No Longer Enrolling: 2/5/2022
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03446040

A Novel Lung Function Imaging Modality as a Preoperative Evaluation Tool (LIME)


Protocol #17-2216, No Longer Enrolling: 3/8/2022
Locations: Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03426306

A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination with Nivolumab in Advanced Solid Tumors


Protocol #18-0033, No Longer Enrolling: 9/11/2020
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03369223

A Phase 1b/2a Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination with Avelumab


Protocol #18-0187, No Longer Enrolling: 10/29/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03409458

A PHASE Ia/Ib, MULTICENTER, OPEN-LABEL, DOSE ESCALATION, DOSE EXPANSION STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF GDC-9545 ALONE OR IN COMBINATION WITH PALBOCICLIB AND/OR LHRH AGONIST IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ESTROGEN RECEPTOR POSITIVE BREAST CANCER


Protocol #17-2208, No Longer Enrolling: 2/17/2021
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03332797

ADVL1615: A Phase I Study of Pevonedistat (MLN4924, IND# 136078), a NEDD8 Activating Enzyme (NAE) Inhibitor, in Combination with Temozolomide and Irinotecan in Pediatric Patients with Recurrent or Refractory Solid Tumors


Protocol #18-0017, No Longer Enrolling: 4/21/2021
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03323034

ADVL1614: A Phase I/II Study of VX15/2503 (IND# 136181) in Children, Adolescents, or Young Adults with Recurrent or Relapsed Solid Tumors


Protocol #18-0320, No Longer Enrolling: 6/5/2020
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03320330

Phase II study of pembrolizumab in combination with binimetinib and bevacizumab in patients with refractory colorectal cancer


Protocol #17-0466, No Longer Enrolling: 9/29/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03475004

A Phase 1/2 Study of Relatlimab (anti-LAG-3 Monoclonal Antibody) Administered in Combination with Both Nivolumab (anti-PD-1 Monoclonal Antibody) and BMS- 986205 (IDO1 inhibitor) or in Combination with Both Nivolumab and Ipilimumab (anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors


Protocol #18-0154, No Longer Enrolling: 4/25/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03459222

Open-label Phase 1 Study to Evaluate Drug-Drug Interactions of Agents Co-Administered with Encorafenib and Binimetinib in Patients with BRAF V600-mutant Unresectable or Metastatic Melanoma or Other Advanced Solid Tumors


Protocol #18-0247, No Longer Enrolling: 3/25/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03864042

A Phase II, Open-Labeled, Multi-Center, Randomized Controlled Trial of Vinblastine +/- Bevacizumab for the Treatment of Chemotherapy-Naive Children with Unresectable or Progressive Low Grade Glioma (LGG)


Protocol #16-2322, No Longer Enrolling: 4/15/2021
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02840409

A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + TGR-1202 with or without Bendamustine and TGR-1202 alone in Patients with Previously Treated Non-Hodgkin's Lymphoma


Protocol #17-6238, No Longer Enrolling: 10/1/2019
Locations: Greeley Hospital, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital
More information available at ClinicalTrials.gov: NCT02793583

A PHASE 1 MULTI-CENTER DOSE-ESCALATION STUDY OF THE SAFETY, TOLERABILITY AND EARLY EFFICACY OF TBX-3400 IN PATIENTS WITH STAGE III AND IV MELANOMA RESISTANT OR REFRACTORY TO IMMUNE CHECKPOINT INHIBITORS


Protocol #18-0385, No Longer Enrolling: 1/4/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03385486

Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) vs. Radiotherapy with Concurrent Cetuximab in Patients with Locoregionally Advanced Head and Neck Cancer with a Contraindication to Cisplatin


Protocol #18-0286, No Longer Enrolling: 8/13/2020
Locations: Greeley Campus, Harmony Campus, Lone Tree Medical Center, Long's Peak Hospital, Longs Peak Hospital, Medical Center of the Rockies, Memorial Hospital Central, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03258554

A Multi-Site Randomized Phase I/II Study of Stereotactic Ablative Body Radiotherapy +/- MEDI 4736 (Durvalumab) for Medically Inoperable Early- Stage Non-Small Cell Lung Cancer


Protocol #18-0504, No Longer Enrolling: 5/13/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03148327

Impact of Oral mCRPC Therapies Stewardship Pilot Program for Veterans


Protocol #18-0167, No Longer Enrolling: 12/23/2020
Locations: Rocky Mountain Regional VA Medical Center

NRG GU-005:PHASE III IGRT AND SBRT VS IGRT AND HYPOFRACTIONATED IMRT FOR LOCALIZED INTERMEDIATE RISK PROSTATE CANCER


Protocol #18-0285, No Longer Enrolling: 10/7/2020
Locations: Lone Tree Medical Center, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03367702

An International, Multicenter, Open-label, Randomized, Phase 3 Study of BLU-285 vs Regorafenib in Patients with Locally Advanced Unresectable or Metastatic Gastrointestinal Stromal Tumor (GIST)


Protocol #18-0269, No Longer Enrolling: 11/8/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03465722

NANT 2017-01: A PHASE I STUDY OF 131I-MIBG WITH DINUTUXIMAB +/- VORINOSTAT FOR RELAPSED/REFRACTORY NEUROBLASTOMA (IND# 137554)


Protocol #18-0501, No Longer Enrolling: 2/3/2024
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03332667

A Phase I Multicenter Study of Immunotherapy in Combination with Chemoradiation in Patients with Advanced Solid Tumors (CLOVER)


Protocol #18-0541, No Longer Enrolling: 4/2/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03509012

A Phase II, randomized, double-blind, study of the use of Rucaparib vs. placebo maintenance therapy in metastatic and recurrent endometrial cancer

This is a phase II, randomized, double-blind, trial for the use of Rucaparib as maintenance therapy in metastatic and recurrent endometrial cancer.
Protocol #18-0567, No Longer Enrolling: 7/15/2023
Locations: Fox Chase Cancer Center, University of Colorado Hospital, University of Pennsylvania, University of Pittsburgh Cancer Institute
More information available at ClinicalTrials.gov: NCT03617679

NANT 2013-01 A Phase I Dose Escalation Study of Autologous Expanded Natural Killer (NK) Cells for Immunotherapy of Relapsed Neuroblastoma with Dinutuximab +/- Lenalidomide. A New Approaches To Neuroblastoma Therapy (NANT) Treatment Protocol


Protocol #18-0686, No Longer Enrolling: 10/4/2022
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02573896

Randomized Phase II Study of Neoadjuvant Nivolumab with and without Urelumab in Cisplatin-Ineligble or Chemotherapy-refusing Patients with Cisplatin-Ineligible Muscle-Invasive Urothelial Carcinoma of the Bladder

A comparison of Neoadjuvant Nivolumab with versus without Urelumab in patients with cisplatin-ineligible bladder cancer
Protocol #18-0760, No Longer Enrolling: 6/2/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02845323

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF TALAZOPARIB WITH ENZALUTAMIDE IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER

A comparison of Talazoparib plus enzalutamide vs placebo plus enzalutamide
Protocol #18-0884, No Longer Enrolling: 4/9/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03395197

RT CHARM: PHASE III RANDOMIZED TRIAL OF HYPOFRACTIONATED POST MASTECTOMY RADIATION WITH BREAST RECONSTRUCTION


Protocol #18-0627, No Longer Enrolling: 8/17/2021
Locations: Highlands Ranch Hospital, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03414970

A Phase 1/2 Dose Escalation and Dose Expansion Study of Ozuriftamab Vedotin (BA3021) Alone and in Combination with Nivolumab in Patients with Advanced Solid Tumors


Protocol #18-0685, No Longer Enrolling: 11/2/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03504488

A Phase Ib/2 Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of Oleclumab (MEDI9447) with or without Durvalumab in Combination with Chemotherapy in Subjects with Metastatic Pancreatic Ductal Adenocarcinoma


Protocol #18-0871, No Longer Enrolling: 10/23/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03611556

COG ANBL1531 - A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or ALK Inhibitor Therapy Added to Intensive Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma (NBL) (IND# 134379)


Protocol #18-0971, No Longer Enrolling: 1/27/2024
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03126916

A PHASE 1B/2 STUDY TO EVALUATE SAFETY AND CLINICAL ACTIVITY OF COMBINATIONS OF AVELUMAB, BINIMETINIB AND TALAZOPARIB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC RAS-MUTANT SOLID TUMORS


Protocol #18-0965, No Longer Enrolling: 4/10/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03637491

ProSTAR: A Phase 1b/2 Study of CPI-1205, a Small Molecule Inhibitor of EZH2, Combined with Enzalutamide or Abiraterone/Prednisone in Patients with Metastatic Castration Resistant Prostate Cancer.

A comparison of enzalutamide with and without CPI1205 in patients with metastatic prostate cancer
Protocol #18-0990, No Longer Enrolling: 3/7/2020
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03480646

Phase I/Ib trial of radiotherapy in combination with Durvalumab (MEDI4736) prior to surgical resection for HPV negative squamous cell carcinoma of the head and neck (HNSCC)


Protocol #18-0606, No Longer Enrolling: 3/3/2021
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Pikes Peak Regional Hospital, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03635164

A Randomized Phase 2 Trial of AM0010 in Combination with Pembrolizumab vs. Pembrolizumab Alone as First-line Therapy in Patients with Metastatic Non-Small Cell Lung Cancer whose Tumors Have High PD-L1 Expression


Protocol #18-6505, No Longer Enrolling: 2/7/2024
Locations: Memorial Hospital Central, Memorial Hospital North, Pikes Peak Regional Hospital
More information available at ClinicalTrials.gov: NCT03382899

A Randomized Phase 2 Trial of AM0010 in Combination With Nivolumab vs. Nivolumab Alone as Second-Line Therapy in Subjects With Stage IV / Metastatic Wild Type Non-Small Cell Lung Cancer and Low Tumor Expression of PD-L1


Protocol #18-6506, No Longer Enrolling: 12/5/2019
Locations: Memorial Hospital Central, Memorial Hospital North, Pikes Peak Regional Hospital
More information available at ClinicalTrials.gov: NCT03382912

A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145/LN-145-S1) for the Treatment of Patients with Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck


Protocol #18-1049, No Longer Enrolling: 12/22/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03083873

A Phase 1, Open-Label, Multicenter, Dose-Escalation Study of RMC-4630 Monotherapy in Adult Participants with Relapsed/Refractory Solid Tumors. Protocol v.1.3


Protocol #18-1150, No Longer Enrolling: 11/16/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03634982

An open-label, Phase I study to assess the safety of NKR-2 treatment administration after a non-myeloablative preconditioning chemotherapy in relapse/refractory acute myeloid leukemia or myelodysplastic syndrome patients.


Protocol #18-1093, No Longer Enrolling: 8/26/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03466320

Nivolumab with standard of care chemotherapy for the first line treatment of peripheral T cell lymphoma


Protocol #18-0708, No Longer Enrolling: 12/18/2020
Locations: City of Hope Cancer Center, Lone Tree Medical Center, Thomas Jefferson University Hospital Cancer Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03586999

Adjuvant Therapy with Pembrolizumab versus Placebo in Resected High Risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE 716) Sponsor Protocol No. MK-3475-716


Protocol #18-1199, No Longer Enrolling: 5/4/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03553836

Effect of guided imagery for radiotherapy-related distress: A randomized controlled trial for patients with head and neck cancer


Protocol #18-1100, No Longer Enrolling: 11/10/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03662698

A221504 A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PILOT STUDY OF AN ORAL, SELECTIVE PERIPHERAL OPIOID RECEPTOR ANTAGONIST IN ADVANCED NON-SMALL CELL LUNG CANCER


Protocol #18-1203, No Longer Enrolling: 7/28/2020
Locations: Memorial Hospital Central, Memorial Hospital North
More information available at ClinicalTrials.gov: NCT03087708

Phase 1-2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-TIM-3 Monoclonal Antibody BGB-A425 in Combination with Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients with Advanced Solid Tumors


Protocol #18-1263, No Longer Enrolling: 2/5/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03744468

A Randomized Phase 2 Study of Losartan and Nivolumab in Combination With FOLFIRINOX and SBRT in Localized Pancreatic Cancer


Protocol #18-1347, No Longer Enrolling: 4/2/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03563248

AN OPEN-LABEL, MULTICENTER, PHASE Ib/II TRIAL EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF MOSUNETUZUMAB (BTCT4465A) IN COMBINATION WITH POLATUZUMAB VEDOTIN IN PATIENTS WITH B-CELL NON HODGKIN LYMPHOMA

This study will evaluate the safety, tolerability, pharmacokinetics, and efficacy of mosunetuzumab in combination with polatuzumab vedotin in patients with B-cell Non-Hodgkin lymphoma.
Protocol #18-1439, No Longer Enrolling: 1/11/2023
Locations: Lone Tree Medical Center, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03671018

A Randomized, Open-label, Phase II Clinical Trial of Relatlimab (anti-LAG-3) plus Nivolumab in Combination with Chemotherapy Versus Nivolumab in Combination with Chemotherapy as First-Line Treatment in Patients with Gastric or Gastroesophageal Junction Adenocarcinoma


Protocol #18-1430, No Longer Enrolling: 10/23/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03662659

An Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Subjects 1 and 30 Years of Age with Relapsed/Refractory Precursor B-cell or T-cell Acute Lympholastic Leukemia or Lymphoblastic Lymphoma


Protocol #18-0867, No Longer Enrolling: 4/13/2022
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03384654

An Open-label, Single-arm, Phase 1b Study to Evaluate the Safety and Efficacy of Grapiprant (ARY-007) in Combination with Pembrolizumab in Patients with Advanced or Progressive Microsatellite Stable (MSS) Colorectal Cancer (CRC)


Protocol #18-1431, No Longer Enrolling: 4/16/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03658772

NRG-DT001: A PHASE IB TRIAL OF NEOADJUVANT AMG 232 CONCURRENT WITH PREOPERATIVE RADIOTHERAPY IN WILD-TYPE P53 SOFT TISSUE SARCOMA (STS)


Protocol #18-1477, No Longer Enrolling: 3/4/2020
Locations: Greeley Hospital, Harmony Campus, Longs Peak Hospital, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03217266

A PHASE II STUDY OF ISATUXIMAB (SAR650984) (NSC-795145) FOR PATIENTS WITH PREVIOUSLY TREATED AL AMYLOIDOSIS


Protocol #18-1214, No Longer Enrolling: 10/2/2019
Locations: Greeley Hospital, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital
More information available at ClinicalTrials.gov: NCT03499808

EA2165 A Randomized Phase III Study of Nivolumab after Combined Modality Therapy (CMT) in High Risk Anal Cancer


Protocol #18-1216, No Longer Enrolling: 8/28/2021
Locations: Greeley Campus, Harmony Campus, Lone Tree Medical Center, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Pikes Peak Regional Hospital, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03233711

ATHENA (A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy)


Protocol #18-1337, No Longer Enrolling: 2/19/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03522246

A Phase 1, Open-Label, Multicenter, Dose Escalation Study of mRNA-2752, a Lipid Nanoparticle Encapsulating mRNAs Encoding Human OX40L, IL-23, and IL-36, for Intratumoral Injection Alone and in Combination with Immune Checkpoint Blockade


Protocol #18-1526, No Longer Enrolling: 10/25/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03739931

Phase 1 Safety Run-In and Phase 2 Randomized Clinical Trial of Anetumab Ravtansine and MK-3475 (Pembrolizumab) Compared to MK-3475 (Pembrolizumab) Alone for Mesothelin-Positive Malignant Pleural Mesothelioma


Protocol #18-1654, No Longer Enrolling: 1/26/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03126630

A Phase 1a / 1b, First-in-human, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-0903 Administered Daily for 21 Days to Patients with Advanced Solid Tumors


Protocol #18-1659, No Longer Enrolling: 6/2/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02729298

A Phase 3, Randomized, Open-label Study of NKTR-214 Combined with Nivolumab Versus Nivolumab in Participants with Previously Untreated Unresectable or Metastatic Melanoma - Sponsor Protocol No. CA045-001


Protocol #18-1343, No Longer Enrolling: 10/2/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03635983

NRG-GU006: A PHASE II, DOUBLE-BLINDED, PLACEBO-CONTROLLED RANDOMIZED TRIAL OF SALVAGE RADIOTHERAPY WITH OR WITHOUT ENHANCED ANTI-ANDROGEN THERAPY WITH APALUTAMIDE IN RECURRENT PROSTATE CANCER (BALANCE)

Evaluating the addition of apalutamide to radiotherapy for men with recurrent prostate cancer
Protocol #18-1742, No Longer Enrolling: 2/14/2020
Locations: Greeley Hospital, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Pikes Peak Regional Hospital, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03371719

An Open-label, Phase 1B Study of NEO-PV-01 + CD40 Agonist Antibody (APX005M) or Ipilimumab with Nivolumab in Patients with Advianced or Metastatic Melanoma - Sponsor Protocol No. NT-003


Protocol #18-1422, No Longer Enrolling: 12/18/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03597282

Phase 1, two-part (dose escalation, dose expansion), multicenter, non-randomized, open-label, multiple dose, first-in-human study of CA102N monotherapy and of CA102N combined with trifluridine/tipiracil (LONSURF) in subjects with advanced solid tumors


Protocol #18-1721, No Longer Enrolling: 1/27/2021
Locations: Greeley Campus, Highlands Ranch Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03616574

A phase I, open-label, dose-escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK3368715 in participants with solid tumors and DLBCL


Protocol #18-1741, No Longer Enrolling: 10/1/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03666988

A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel Cell Carcinoma


Protocol #18-1599, No Longer Enrolling: 6/22/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03599713

Square wave testosterone therapy in castration resistant prostate cancer

Feasibility of the administration of transdermal testosterone alternating with enzalutamide and the effects it has in the treatment of prostate cancer
Protocol #18-0821, No Longer Enrolling: 5/25/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03734653

A211401: REDUCING SURGICAL COMPLICATIONS IN NEWLY DIAGNOSED LUNG CANCER PATIENTS WHO SMOKE CIGARETTES


Protocol #18-1595, No Longer Enrolling: 11/19/2019
Locations: Memorial Hospital Central, Memorial Hospital North
More information available at ClinicalTrials.gov: NCT02856581

Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects with Previously Treated c-Met+ Non-Small Cell Lung Cancer


Protocol #18-1728, No Longer Enrolling: 6/17/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03539536

An Open-Label, Multicenter, First in Human, Phase 1 Dose Escalation and Multicohort Expansion Study of INBRX-109 in Subjects with Locally Advanced or Metastatic Solid Tumors Including Sarcomas


Protocol #18-1672, No Longer Enrolling: 2/7/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03715933

A multicenter study with an open-label Phase Ib part followed by a randomized, placebo-controlled, double-blind, Phase II part to evaluate efficacy, safety, tolerability, and pharmacokinetics of the DNA-PK inhibitor M3814 in combination with capecitabine and radiotherapy in participants with locally advanced rectal cancer


Protocol #18-1869, No Longer Enrolling: 10/1/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03770689

Open Label Phase 2 Study of Tisotumab Vedotin for Patients with Platinum-Resistant Ovarian Cancer with a Safety Run-in of a Dose-Dense Regimen


Protocol #18-6061, No Longer Enrolling: 5/8/2021
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies
More information available at ClinicalTrials.gov: NCT03657043

A PHASE 3, MULTICENTER, RANDOMIZED, OPEN LABEL STUDY TO COMPARE THE EFFICACY AND SAFETY OF BB2121 VERSUS STANDARD REGIMENS IN SUBJECTS WITH RELAPSED AND REFRACTORY MULTIPLE MYELOMA (RRMM) (KarMMa-3)


Protocol #18-1983, No Longer Enrolling: 3/21/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03651128

A Phase II, Open Label, Randomised, Multi-centre Study to Assess the Safety and Efficacy of Agents Targeting DNA Damage Repair in Combination with Olaparib versus Olaparib Monotherapy in the Treatment of Metastatic Triple Negative Breast Cancer Patients Stratified by Alterations in Homologous Recombinant Repair (HRR)-related Genes


Protocol #18-1933, No Longer Enrolling: 11/25/2020
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03330847

A RANDOMIZED PHASE 3, OPEN-LABEL TRIAL OF SIPULEUCEL-T ADMINISTERED TO PATIENTS ON ACTIVE SURVEILLANCE FOR NEWLY DIAGNOSED PROSTATE CANCER

A comparison of Provenge versus active surveillance in low risk prostate cancer patients.
Protocol #18-1980, No Longer Enrolling: 10/5/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03686683

Randomized phase II trial of osimertinib with or without local consolidation therapy (LCT) for patients with EGFR-mutant metastatic NSCLC (NORTHSTAR)


Protocol #18-2051, No Longer Enrolling: 12/1/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03410043

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Nirogacestat Versus Placebo in Adult Patients with Progressing Desmoid Tumors/Aggressive Fibromatosis (DT/AF).


Protocol #18-1858, No Longer Enrolling: 7/10/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03785964

A Phase 3, Interventional, Randomized, Multicenter, Open-Label Study of DCC-2618 vs Sunitinib in Patients with Advanced Gastrointestinal Stromal Tumors after Treatment with Imatinib


Protocol #18-1856, No Longer Enrolling: 12/1/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03673501

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Cabozantinib (XL184) in Subjects with Radioiodine-Refractory Differentiated Thyroid Cancer Who Have Progressed after Prior VEGFR-Targeted Therapy


Protocol #18-1919, No Longer Enrolling: 1/8/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03690388

An Open-label, Phase 1b/2 Study of Acalabrutinib Alone or in Combination Therapy in Subjects with B-cell Non-Hodgkin Lymphoma


Protocol #18-6510, No Longer Enrolling: 9/29/2021
Locations: Memorial Hospital Central, Memorial Hospital North, Pikes Peak Regional Hospital
More information available at ClinicalTrials.gov: NCT02180711

Phase I trial of indoximod in combination with temozolomide-based therapy for children with progressive primary brain tumors (NLG2105)


Protocol #18-2309, No Longer Enrolling: 9/30/2020
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02502708

A PHASE 1 STUDY OF FOR46 ADMINISTERED EVERY 21 DAYS IN PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM)

Evaluate the safety and tolerability of FOR46 at escalating dose levels and administered intravenously (IV) every 21 days in relapsed/refractory multiple myeloma patients. And determine the maximum-tolerated dose and/or the recommended Phase 2 dose (RP2D) of FOR46 administered IV every 21 days in relapsed/refractory multiple myeloma patients.
Protocol #18-2354, No Longer Enrolling: 2/4/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03650491

"A Phase 1 Open-Label Study to Evaluate the Safety and Antitumor Activity of oncastuximab Tesirine and Durvalumab in Patients with advanced Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, or Follicular Lymphoma"


Protocol #18-6118, No Longer Enrolling: 11/26/2019
Locations: Memorial Hospital Central, Memorial Hospital North, Pikes Peak Regional Hospital
More information available at ClinicalTrials.gov: NCT03685344

A PHASE 1 STUDY OF OKI-179 AS A SINGLE AGENT IN PATIENTS WITH ADVANCED SOLID TUMORS


Protocol #18-1816, No Longer Enrolling: 10/2/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03931681

A Phase 3 Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) and Lenvatinib (E7080/MK-7902) Versus Pembrolizumab Alone as First-line Intervention in Participants with Advanced Melanoma (LEAP-003)


Protocol #18-2198, No Longer Enrolling: 5/6/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03820986

Phase 1b/2, Open-Label Study Evaluating the Safety and Efficacy of KRT-232 in Patients with p53 Wild-Type (p53WT) Merkel Cell Carcinoma (MCC) Who Have Failed Anti-PD-1 or Anti-PD-L1 Immunotherapy, or in Combination with Avelumab in MCC Patients who are Anti-PD-1 or Anti-PD-L1 Treatment Naive


Protocol #18-2284, No Longer Enrolling: 10/6/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03787602

Phase II, open-label, single arm, multicenter study of encorafenib, binimetinib plus cetuximab in subjects with previously untreated BRAF V600E -mutant Metastatic Colorectal Cancer


Protocol #18-2293, No Longer Enrolling: 1/31/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03693170

A Phase 1b/2 Study of FT-2102 in Patients with Advanced Solid Tumors and Gliomas with an IDH1 Mutation


Protocol #18-2219, No Longer Enrolling: 8/28/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03684811

Phase I/II study of dabrafenib, trametinib, and navitoclax in BRAF mutant melanoma (Phase I and II) and other solid tumors (Phase I only).


Protocol #18-2382, No Longer Enrolling: 12/11/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT01989585

A PHASE 2 STUDY OF AZD1775, A WEE1 INHIBITOR, IN PATIENTS WITH CCNE1 AMPLIFICATION


Protocol #18-2334, No Longer Enrolling: 7/11/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03253679

A Phase 2 Study of M6620 in Combination with Carboplatin compared with Docetaxel in Combination with Carboplatin in Metastatic Castration-Resistant Prostate Cancer

A comparison of M6620 + Carboplatin versus Docetaxel + Carboplatin in metastatic castrate-resistant prostate cancer
Protocol #18-2398, No Longer Enrolling: 8/7/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03517969

A Phase 2, multicenter, open-label, 2-cohort study of trastuzumab deruxtecan (DS-8201a), an anti-HER2 antibody drug conjugate (ADC), for HER2-over-expressing or -mutated, unresectable and/or metastatic non-small cell lung cancer (NSCLC)


Protocol #18-2488, No Longer Enrolling: 12/16/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03505710

A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects with Selected Solid Tumors (LEAP-005)


Protocol #18-2466, No Longer Enrolling: 4/10/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03797326

A Phase 2, Open-label, Multicenter, Randomized, Multidrug Platform Study of Durvalumab Alone or in Combination with Novel Agents in Subjects with Locally Advanced, Unresectable, Stage III Non-small Cell Lung Cancer (COAST)


Protocol #18-2487, No Longer Enrolling: 7/1/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03822351

Predictors of physical activity maintenance in colorectal cancer survivors

Supervised low to moderate intensity aerobic and resistance exercise, twice per week for 60 minutes. Four, 1-hour PA behavior change education/discussion sessions.
Protocol #18-2436, No Longer Enrolling: 10/11/2022
Locations: Anschutz Health and Wellness, Colorado State University, Harmony Campus, Poudre Valley Hospital, UCD Anschutz Health & Wellness Center
More information available at ClinicalTrials.gov: NCT03781154

A Stepped Care Intervention to Reduce Disparities in Mental Health Services among Underserved Lung and Head-and-Neck Cancer Patients and their Caregivers.


Protocol #16-2621, No Longer Enrolling: 1/6/2021
Locations: Denver Health Medical Center, National Jewish Health, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03016403

Phase I Study of Dual Immune Checkpoint Blockade (Anti-PD-L1 (Durvalumab) (MEDI4736) and Anti-CTLA4 (Tremelimumab) Plus Yttrium-90 (Y-90) Radioembolization & Stereotactic Body Radiation Therapy (SBRT) in Refractory Metastatic MSS (Microsatellite Stable) Colorectal Cancer with Liver Metastases


Protocol #18-0710, No Longer Enrolling: 10/1/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03802747

A phase III, multicenter, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, early breast cancer (New Adjuvant TriAl with Ribociclib [LEE011]:NATALEE).


Protocol #18-2357, No Longer Enrolling: 4/9/2020
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03701334

PHASE II, DOUBLE-BLIND, RANDOMIZED TRIAL OF AVOVA-1 (AUTOLOGOUS DENDRITIC CELLS LOADED WITH AUTOLOGOUS TUMOR ASSOCIATED ANTIGENS) VS. AUTOLOGOUS PERIPHERAL BLOOD MONONUCLEAR CELLS (MC) IN PATIENTS WITH STAGE III OR IV EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CARCINOMA AFTER PRIMARY THERAPY


Protocol #18-2569, No Longer Enrolling: 6/10/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02033616

A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-144/LN-145/LN-145-S1) in Patients with Solid Tumors


Protocol #18-2520, No Longer Enrolling: 8/5/2022
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03645928

A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination in Women with ER-positive, HER2 negative Advanced Breast Cancer (SERENA-1)


Protocol #18-2654, No Longer Enrolling: 2/21/2024
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03616587

A Phase 2 Study to Evaluate the Clinical Activity of Tarloxotinib in Patients with Non-Small Cell Lung Cancer that Harbors Either an EGFR Exon 20 Insertion or a HER2-Activating Mutation and Other Advanced Solid Tumors with NRG1/ERBB Family Gene Fusions


Protocol #19-0011, No Longer Enrolling: 1/30/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03805841

A randomized, multicenter, parallel-group, Phase III study to compare the efficacy of arfolitixorin versus leucovorin in combination with 5-fluorouracil, oxaliplatin, and bevacizumab in patients with advanced colorectal cancer


Protocol #18-6515, No Longer Enrolling: 9/14/2021
Locations: Memorial Hospital Central
More information available at ClinicalTrials.gov: NCT03750786

Pilot Study of Dynamic Contrast Enhanced Computed Tomography (DCE-CT) Imaging for the assessment of radiation therapy outcome for liver cancer patients


Protocol #18-2874, No Longer Enrolling: 1/7/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03891654

The MAP TRIAL: PHASE III STUDY OF MUSCADINE PLUS (MPX) IN MEN WITH PROSTATE CANCER: A RANDOMIZED DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE EFFECTS OF MPX CAPSULES ON RISING PROSTATE-SPECIFIC ANTIGEN LEVELS IN ALANINE/ALANINE SOD2 GENOTYPE MEN FOLLOWING INITIAL THERAPY FOR PROSTATE CANCER

A double blind comparison of MPX versus placebo in men with prostate cancer.
Protocol #18-2604, No Longer Enrolling: 7/12/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03535675

AREN1721: A Randomized Phase 2 Trial of Axitinib/Nivolumab Combination Therapy vs. Single Agent Axitinib or Nivolumab for the Treatment of TFE/Translocation Renal Cell Carcinoma (tRCC) Across All Age Groups

A comparison of Axitinib plus Nivolumab vs Axitinib vs Nivolumab in treatment of unresectable kidney cancer
Protocol #19-0048, No Longer Enrolling: 3/17/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03595124

A PHASE III, DOUBLE-BLINDED, MULTICENTER, RANDOMIZED STUDY EVALUATING THE EFFICACY AND SAFETY OF NEOADJUVANT TREATMENT WITH ATEZOLIZUMAB OR PLACEBO IN COMBINATION WITH PLATINUM-BASED CHEMOTHERAPY IN PATIENTS WITH RESECTABLE STAGE II, IIIA, OR SELECT IIIB NON SMALL CELL LUNG CANCER


Protocol #19-0127, No Longer Enrolling: 7/27/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03456063

A PHASE 1 STUDY TO EVALUATE THE EFFECT OF HEPATIC IMPAIRMENT ON THE PHARMACOKINETICS AND SAFETY OF LORLATINIB IN ADVANCED CANCER PATIENTS


Protocol #19-0233, No Longer Enrolling: 4/10/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03726333

An Open-Label, Multicenter, Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination with Paclitaxel to Assess Safety, Tolerability, and Pharmacokinetics in Patients with Advanced or Metastatic Solid Tumors


Protocol #19-0207, No Longer Enrolling: 11/16/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03601897

A PHASE I, MULTICENTER, OPEN-LABEL PREOPERATIVE, SHORT-TERM WINDOW STUDY OF GDC-9545 IN POSTMENOPAUSAL WOMEN WITH STAGE I-III OPERABLE, ESTROGEN RECEPTOR-POSITIVE BREAST CANCER

A PHASE I, MULTICENTER, OPEN-LABEL PREOPERATIVE, SHORT-TERM WINDOW STUDY OF GDC-9545 IN POSTMENOPAUSAL WOMEN WITH STAGE IIII OPERABLE, ESTROGEN RECEPTORPOSITIVE BREAST CANCER
Protocol #19-0206, No Longer Enrolling: 6/9/2021
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03916744

Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in subjects with Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer (MBC) who have failed at least two prior chemotherapy regimens


Protocol #19-0326, No Longer Enrolling: 3/25/2020
Locations: Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03901339

A Phase 1, open label, first-in-human study of TR1801-ADC, an antibody drug conjugate (ADC), in patients with select solid tumors expressing c-Met


Protocol #19-0232, No Longer Enrolling: 10/9/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03859752

A PHASE II, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY OF THE EFFICACY AND SAFETY OF RO7198457 IN COMBINATION WITH PEMBROLIZUMAB VERSUS PEMBROLIZUMAB IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED MELANOMA


Protocol #19-0172, No Longer Enrolling: 12/2/2021
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03815058

A Phase 2, Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-Mutant Melanoma Brain Metastasis


Protocol #19-0161, No Longer Enrolling: 4/3/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03911869

Elacestrant Monotherapy vs. Standard of Care for the Treatment of Patients with ER+/HER2- Advanced Breast Cancer Following CDK4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-Label, Active-Controlled, Multicenter Trial


Protocol #19-6041, No Longer Enrolling: 9/9/2020
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital
More information available at ClinicalTrials.gov: NCT03778931

A Phase 3, Randomized, Double-blind Study of Pembrolizumab (MK-3475) Plus Docetaxel Plus Prednisone versus Placebo Plus Docetaxel Plus Prednisone in Participants with Chemotherapy-naive Metastatic Castration-Resistant Prostate Cancer (mCRPC) who have Progressed on a Next Generation Hormonal Agent (NHA) (KEYNOTE- 921)

A comparison of Pembrolizumab plus Docetaxel versus placebo plus Docetaxel in patients with chemo-naive, metastatic prostate cancer.
Protocol #19-0473, No Longer Enrolling: 5/21/2021
Locations: Highlands Ranch Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03834506

A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-641)

A double blind comparison of enzalutamide plus pembrolizumab or placebo in patients with metastatic prostate cancer.
Protocol #19-0493, No Longer Enrolling: 5/3/2022
Locations: Highlands Ranch Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03834493

A Multi-Center, Open-Label, phase I/Ib, Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anticancer Activity of Fruquintinib in Patients with Advanced Solid Tumors


Protocol #19-0539, No Longer Enrolling: 10/26/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03251378

A Phase 3 Randomized, Open-Label, Study of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for First-line Treatment of Advanced or Recurrent Endometrial Carcinoma (LEAP-001)


Protocol #19-0507, No Longer Enrolling: 6/17/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03884101

A randomized phase II study of anti-PD-1 and limited metastatic site radiation therapy versus anti-PD-1 alone for patients with microsatellite instability-high (MSI-H) and mismatch repair deficient (dMMR) metastatic solid tumors


Protocol #19-0556, No Longer Enrolling: 11/18/2021
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04001101

Treatment Patterns, Mechanisms of Resistance and Outcomes among patients with EGFR, ALK and ROS1 Translocated Non-Small Cell Lung Cancer: An ATOMIC Consortium Analysis


Protocol #19-0702, No Longer Enrolling: 12/21/2019
Locations: University of Colorado Hospital

S1600 A Randomized Phase III Double-Blind Clinical Trial Evaluating the Effect of Immune-Enhancing Nutrition on Radical Cystectomy Outcomes

Comparison of drink supplements in evaluation of post-operative Bladder cancer patients
Protocol #19-0818, No Longer Enrolling: 8/10/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03757949

EA8171: Multiparametric MRI (mpMRI) for Preoperative Staging and Treatment Planning for Newly-Diagnosed Prostate Cancer

Multiparametric MRI in Evaluating Cancer Stage and Helping Treatment Planning in Patients With Prostate cancer
Protocol #19-0819, No Longer Enrolling: 10/17/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03697148

An Open-Label, Phase II Efficacy Trial of Doxorubicin in Combination with Dual Checkpoint Blockade using Zalifrelimab (AGEN1884) and Balstilimab (AGEN2034) for Advanced or Metastatic Soft Tissue Sarcomas


Protocol #19-0554, No Longer Enrolling: 4/20/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04028063

NRG GY017: Anti PD-L1 (Atezolizumab) as an Immune Primer and Concurrently with Extended Field Chemoradiotherapy for Node Positive Locally Advanced Cervical Cancer


Protocol #19-1151, No Longer Enrolling: 6/12/2020
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03738228

NRG-BR004: A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer


Protocol #19-1152, No Longer Enrolling: 5/4/2022
Locations: Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03199885

EA5163/S1709 INSIGNA: A Randomized, Phase III Study of Firstline Immunotherapy alone or in Combination with Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) with Immunobiomarker SIGNature-driven Analysis


Protocol #19-1121, No Longer Enrolling: 10/27/2020
Locations: Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03793179

S1900A, A PHASE II STUDY OF RUCAPARIB IN PATIENTS WITH GENOMIC LOH HIGH AND/OR DELETERIOUS BRCA1/2 MUTATION STAGE IV OR RECURRENT NON-SMALL CELL LUNG CANCER (Lung-MAP SUB-STUDY)


Protocol #19-1317, No Longer Enrolling: 7/21/2020
Locations: Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03845296

S1800A, A PHASE II RANDOMIZED STUDY OF RAMUCIRUMAB PLUS MK3475 (PEMBROLIZUMAB) VERSUS STANDARD OF CARE FOR PATIENTS PREVIOUSLY TREATED WITH IMMUNOTHERAPY FOR STAGE IV OR RECURRENT NON-SMALL CELL LUNG CANCER (LUNG-MAP NON-MATCHED SUB-STUDY)


Protocol #19-1318, No Longer Enrolling: 11/21/2020
Locations: Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03971474

Assessing patient preferences and a clinical tool for evaluating for sexual function in adolescent and young adult survivors of childhood cancer


Protocol #19-1111, No Longer Enrolling: 12/4/2020
Locations: Childrens Hospital Colorado, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04066218

10100: A Randomized, Phase 2 Trial to Evaluate the Safety and Efficacy of Eribulin Mesylate in Combination with Atezolizumab Compared to Atezolizumab Alone in Subjects with Locally Advanced or Metastatic Transitional Cell Urothelial Cancer Where Platinum-Based Treatment is Not an Option


Protocol #19-1394, No Longer Enrolling: 3/17/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03237780

This is our 15.4 Health Affairs testing protocol


Protocol #X19-9999, No Longer Enrolling: 6/2/2020
Locations: Department Specific Free Standing Clinic, Highlands Ranch Hospital, University of Colorado Hospital

A Phase 2, Randomized, Open-label, 3-arm Study of Relacorilant in Combination with Nab-Paclitaxel for Patients with Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer


Protocol #19-0591, No Longer Enrolling: 7/28/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03776812

ELACESTRANT MONOTHERAPY VS. STANDARD OF CARE FOR THE TREATMENT OF PATIENTS WITH ER+/HER2- ADVANCED BREAST CANCER FOLLOWING CDK4/6 INHIBITOR THERAPY: A PHASE 3 RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER TRIAL (EMERALD)


Protocol #19-0327, No Longer Enrolling: 9/26/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03778931

Analyzing differences in treatment regimens and outcomes in elderly breast, lung, and colorectal cancer patients using the SEER-Medicare database


Protocol #18-0156, No Longer Enrolling: 11/28/2019

Serum Acetaminophen-Cystein (APAP-CYS) Adduct Concentrations in Subjects Expected to Develop Aminotransferase Elevations with Liver-Directed Therapy Intended to Treat Hepatic Tumors

This study aims to describe protein adduct (an experimental biomarker of acetaminophen exposure) concentrations in patients taking therapeutic doses of acetaminophen who develop a liver injury from a cause other than acetaminophen. To describe serum acetaminophen-cysteine adduct (an experimental biomarker of acetaminophen exposure) concentrations following hepatic embolization in patients taking therapeutic doses of acetaminophen three days before the procedure
Protocol #16-0031, No Longer Enrolling: 9/3/2021
Locations: CTRC Inpatient, Denver Health and Hospital Authority, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02911961

A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined with Ipilimumab vs Placebo in Participants with Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse


Protocol #19-0905, No Longer Enrolling: 2/23/2022
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03138512

A Phase I/II Open-label, Multi-center Study of the Safety and Efficacy of IMCnyeso, an HLA- A0201-Restricted, NY-ESO-1- and LAGE-1A-specific Soluble T Cell Receptor and Anti-CD3 Bispecific Molecule, as a Single Agent in HLA-A0201 Positive Patients with Advanced NY-ESO-1 and/or LAGE-1A Positive Cancer.


Protocol #18-2404, No Longer Enrolling: 3/27/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03515551

Phase 1 Dose Escalation and Expansion Cohort Trial of Carboplatin and Gemcitabine with or without M6620 (VX-970) in First or Second Recurrence Platinum-Sensitive Epithelial Ovarian, Peritoneal, and Fallopian Tube Cancer


Protocol #19-0457, No Longer Enrolling: 9/2/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02627443

A Phase II Study of the PARP Inhibitor Olaparib in Combination with the DNA Damaging Agent Temozolomide for the Treatment of Advanced Uterine Leiomyosarcoma


Protocol #19-2018, No Longer Enrolling: 2/22/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03880019

CEMIPLIMAB SURVIVORSHIP EPIDEMIOLOGY (CASE) STUDY


Protocol #19-0519, No Longer Enrolling: 12/7/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03836105

NRG-LU003: A BIOMARKER-DRIVEN PROTOCOL FOR PREVIOUSLY TREATED ALK-POSITIVE NON-SQUAMOUS NSCLC PATIENTS: THE NCI-NRG ALK PROTOCOL


Protocol #19-1146, No Longer Enrolling: 4/2/2021
Locations: Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03737994

An Open-Label Dose Escalation Trial to Evaluate Dose Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD), Safety, and Tolerability of Microneedle Arrays containing Doxorubicin (D-MNA) in Participants with Basal Cell Carcinoma (BCC)

The participant will be treated with microneedle arrays containing doxorubicin (D-MNA) or microneedle arrays containing placebo. The D-MNA or MNA-placebo is applied to the BCC lesion and secured to the skin with a self-adhesive bandage. The D-MNA is removed from the skin after 30 minutes. Each participant will receive three (3) weekly applications of the D-MNA unless a dose limiting toxicity (DLT) requires skipping or postponement of an application. The investigational product is chemotherapeutic agent doxorubicin (25 ug, 50 ug, 100 ug, or 200 ug) delivered to specific skin strata by a novel delivery system, MNA or placebo delivered to specific skin strata by MNA.
Protocol #19-0035, No Longer Enrolling: 12/18/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03646188

A Phase 2 Open Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects with Metastatic Solid Tumors


Protocol #19-0946, No Longer Enrolling: 3/21/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03964727

A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab versus Placebo for Participants with Hepatocellular Carcinoma Who Are at High Risk of Recurrence after Curative Hepatic Resection or Ablation


Protocol #19-0820, No Longer Enrolling: 1/6/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03383458

A Phase 1/2, First-in-Human, Open-label, Dose Escalation Study of GB1275 Monotherapy and in Combination with an Anti-PD-1 Antibody in Patients with Specified Advanced Solid Tumors or in Combination with Standard of Care in Patients with Metastatic Pancreatic Adenocarcinoma, Followed by Basket Expansion of GB1275 with Standard of Care or in Combination with an Anti-PD-1 Antibody in Patients with Specified Metastatic Solid Tumors


Protocol #19-1302, No Longer Enrolling: 7/1/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04060342

COG AHOD1822 / Merck MK-3475-667: An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults with Newly Diagnosed Classical Hodgkin Lymphoma with Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE 667)


Protocol #19-1481, No Longer Enrolling: 4/4/2023
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03407144

A Randomized, Single-Blinded, Phase 3 Study of Second- or Third-Line Chemotherapy with Docetaxel + Plinabulin Compared to Docetaxel + Placebo in Patients with Advanced Non-Small Cell Lung Cancer with at Least One Measurable Lung Lesion (DUBLIN-3)


Protocol #15-6056, No Longer Enrolling: 12/25/2019
Locations: Memorial Hospital Central

Randomized Phase II Trial of Topotecan plus M6620 (VX-970) vs. Topotecan alone in Patients with Relapsed Small-Cell Lung Cancer


Protocol #19-2129, No Longer Enrolling: 1/29/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03896503

A Phase III Study of AL3818 (Anlotinib) Hydrochloride Monotherapy in Subjects with Metastatic or Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma and Synovial Sarcoma


Protocol #18-2646, No Longer Enrolling: 7/18/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03016819

SGNTUC-016: Randomized, double-blind, phase 3 study of tucatinib or placebo in combination with ado-trastuzumab emtansine (T-DM1) for subjects with unresectable locally-advanced or metastatic Her2+ breast cancer


Protocol #19-6076, No Longer Enrolling: 11/17/2021
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital
More information available at ClinicalTrials.gov: NCT03975647

Randomized, double-blind, phase 3 study of tucatinib or placebo in combination with ado-trastuzumab emtansine (T-DM1) for subjects with unresectable locally-advanced or metastatic HER2+ breast cancer


Protocol #19-6509, No Longer Enrolling: 12/6/2021
Locations: Memorial Hospital Central, Memorial Hospital North, Pikes Peak Regional Hospital
More information available at ClinicalTrials.gov: NCT03975647

A PHASE 3B, MULTICENTER, SINGLE-ARM, OPENLABEL EFFICACY AND SAFETY STUDY OF FEDRATINIB IN SUBJECTS WITH DIPSSINTERMEDIATE OR HIGH-RISK PRIMARY MYELOFIBROSIS, POST-POLYCYTHEMIA VERA MYELOFIBROSIS, OR POST-ESSENTIAL THROMBOCYTHEMIA MYELOFIBROSIS AND PREVIOUSLY TREATED WITH RUXOLITINIB


Protocol #19-0562, No Longer Enrolling: 1/22/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03755518

A Phase 1/2, Open Label, Dose-Escalation Study of Oral ORIN1001 with and without Chemotherapy in the Treatment of Subjects with Solid Tumors


Protocol #19-1118, No Longer Enrolling: 1/13/2023
Locations: Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03950570

Alpha lipoic acid to decrease treatment related pain and side effects during concurrent chemoradiation in HNSCC


Protocol #19-1081, No Longer Enrolling: 8/8/2023
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04042935

A Randomized, Open-Label, Phase 1-2 Study of ASTX727 Low Dose (ASTX727 LD) Extended Schedule in Subjects with Lower Risk (IPSS Low or Intermediate-1) Myelodysplastic Syndromes (MDS)


Protocol #18-0818, No Longer Enrolling: 3/21/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03502668

Improving physical activity maintenance following an exercise program for cancer survivors


Protocol #19-0323, No Longer Enrolling: 10/13/2020
Locations: Anschutz Health and Wellness, UCD Anschutz Health & Wellness Center
More information available at ClinicalTrials.gov: NCT03976193

A Multicenter, Open-Label, Non-Randomised First in Human Study of NG-350A in Patients with Metastatic or Advanced Epithelial Tumours (FORTITUDE)


Protocol #19-1147, No Longer Enrolling: 8/26/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03852511

A Phase I study of Anetumab Ravtansine in Combination with either Anti-PD-1 Antibody, or Anti-CTLA4 and Anti-PD-1 Antibodies or Anti-PD-1 Antibody and Gemcitabine in Mesothelin-Positive Advanced Pancreatic Adenocarcinoma


Protocol #19-0821, No Longer Enrolling: 3/13/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03816358

PBTC-051: Phase I Study to Evaluate the Safety and Tolerability of the CD40 Agonistic Monoclonal Antibody APX005M in Pediatric Subjects with Recurrent/Refractory Brain Tumors and Newly Diagnosed Brain Stem Glioma

1.1 Primary Objectives 1.1.1 To evaluate the safety of APX005M administered intravenously every 3 weeks to children with central nervous system tumors. 1.1.2 To determine the maximum tolerated dose and/or the recommended phase II dose of APX005M. 1.1.3 To determine the pharmacokinetics of APX005M. 1.2 Secondary Objective 1.2.1 To make a preliminary assessment of efficacy via overall response rate, duration of response, progression-free survival and overall survival for DIPG patients. 1.3 Exploratory Objectives 1.3.1 To assess the incidence of anti-drug antibodies. 1.3.2 To determine the immune pharmacodynamics of APX005M. 1.3.3 To identify tumor and blood efficacy and/or resistance biomarkers.
Protocol #17-2394, No Longer Enrolling: 12/15/2023
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03389802

ANBL1821 - A Phase 2 Randomized Study of Irinotecan/Temozolomide/Dinutuximab with or without Eflornithine (DFMO) (IND# 141913) in Children with Relapsed, Refractory or Progressive Neuroblastoma


Protocol #19-1259, No Longer Enrolling: 1/27/2024
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03794349

COG AREN1721 - A Randomized Phase 2 Trial of Axitinib/Nivolumab Combination Therapy vs. Single Agent Nivolumab for the Treatment of TFE/Translocation Renal Cell Carcinoma (tRCC) Across All Age Groups


Protocol #19-1467, No Longer Enrolling: 3/28/2023
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03595124

A031704: PD-Inhibitor (Nivolumab) and Ipilimumab Followed by Nivolumab vs. VEGF TKI Cabozantinib With Nivolumab: A Phase III Trial in Metastatic Untreated Renal Cell Cancer [PDIGREE]


Protocol #19-1913, No Longer Enrolling: 3/10/2021
Locations: Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03793166

A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants with Advanced and/or Unresectable Biliary Tract Carcinoma


Protocol #19-1503, No Longer Enrolling: 3/23/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04003636

AINV18P1: A Phase I Study of Palbociclib (IND# 141416), a CDK4/6 Inhibitor, in Combination with Chemotherapy in Children with Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL)


Protocol #19-0549, No Longer Enrolling: 5/25/2021
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03792256

Patient characteristics, treatment patterns and outcomes in patients with advanced or metastatic Non-Small Cell Lung Cancer with MET alterations - a multi-country chart review


Protocol #19-1346, No Longer Enrolling: 12/21/2019
Locations: University of Colorado Hospital

Multiple Part Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma Subjects with A+AVD."


Protocol #19-6510, No Longer Enrolling: 5/26/2022
Locations: Memorial Hospital Central, Memorial Hospital North, Pikes Peak Regional Hospital
More information available at ClinicalTrials.gov: NCT03646123

A Phase 1, Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Study of SQZ-PBMC-HPV as Monotherapy and in Combination with Atezolizumab or Other Immune Checkpoint Inhibitors in HLA-A*02+ Patients with HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors


Protocol #19-1727, No Longer Enrolling: 1/7/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04084951

A Phase 3, Randomized, Double-blind, Active Comparator-controlled, Multicenter Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Recipients of Allogeneic Hematopoietic Stem Cell Transplant (PNEU-STEM)


Protocol #19-0536, No Longer Enrolling: 9/30/2020
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03565900

A large-scale multicenter phase II study evaluating the protective effect of a tissue selective estrogen complex (TSEC) in women with newly diagnosed ductal carcinoma in situ.


Protocol #19-0632, No Longer Enrolling: 8/23/2022
Locations: Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02694809

A Phase 2 Randomized Study of Adjuvant Immunotherapy With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab Versus Pembrolizumab Alone After Complete Resection of High-Risk Melanoma


Protocol #19-0642, No Longer Enrolling: 3/18/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03897881

A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Olaparib Alone or in Combination With Bevacizumab Compared to Bevacizumab With 5-FU in Participants with Unresectable or Metastatic Colorectal Cancer who Have not Progressed Following First-line Induction of FOLFOX With Bevacizumab (LYNK-003)


Protocol #19-6513, No Longer Enrolling: 11/2/2021
Locations: Memorial Hospital Central, Memorial Hospital North, Pikes Peak Regional Hospital
More information available at ClinicalTrials.gov: NCT04456699

A Multicenter, Double Blind, Randomized, Controlled Study of M7824 with Concurrent Chemoradiation Followed by M7824 versus Concurrent Chemoradiation Plus Placebo Followed by Durvalumab in Participants with Unresectable Stage III Non-small Cell Lung Cancer


Protocol #19-6066, No Longer Enrolling: 7/25/2020
Locations: Memorial Hospital Central, Memorial Hospital North, Pikes Peak Regional Hospital
More information available at ClinicalTrials.gov: NCT03840902

A Single Cohort Phase 4 Trial Investigating the Impact of G-CSF Primary Prophylaxis for Advanced Stage Hodgkin Lymphoma Patients Treated with A+AVD


Protocol #19-6060, No Longer Enrolling: 11/20/2021
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital
More information available at ClinicalTrials.gov: NCT03646123

EA3161: A Phase III Randomized Study of Maintenance Nivolumab versus Observation in Patients with Locally Advanced, Intermediate Risk HPV Positive OPSCC


Protocol #19-2554, No Longer Enrolling: 6/22/2023
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital
More information available at ClinicalTrials.gov: NCT03811015

NRG-GY018: A Phase III Randomized, Placebo-Controlled Study of Pembrolizumab (MK-3475, NSC #776864) in Addition to Paclitaxel and Carboplatin for Measurable Stage III or IVA, Stage IVB or Recurrent Endometrial Cancer


Protocol #19-2828, No Longer Enrolling: 4/8/2020
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital
More information available at ClinicalTrials.gov: NCT03914612

COG ACCL1633 - The Effectiveness of Lactobacillus plantarum (LBP, IND# 17339) in Preventing Acute Graft-versus-Host Disease (GvHD) in Children undergoing Alternative Hematopoietic Progenitor Cell Transplantation (HCT)


Protocol #18-1349, No Longer Enrolling: 4/20/2022
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03057054

COG ACCL10P1 - Computerized Cognitive Training for Pediatric Brain Tumor Patients: A Pilot Study


Protocol #18-2000, No Longer Enrolling: 12/2/2020
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT01503086

COG ANHL1522 - A Pilot Study of Rituximab (RTX) and Third Party Latent Membrane Protein (LMP)-specific Cytotoxic T-Lymphocytes (LMP-TC, IND # 17068) in Pediatric Solid Organ Recipients (SOT) with EBV-Positive CD20-Positive Post-Transplant Lymphoproliferative Disease (PTLD)


Protocol #18-0198, No Longer Enrolling: 12/22/2020
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02900976

An Open-Label, Multicenter, First-in-Human, Dose-Escalation, Phase 1 Study of INBRX-105 and INBRX-105 in Combination with Pembrolizumab in Patients with Locally Advanced or Metastatic Solid Tumors


Protocol #19-1145, No Longer Enrolling: 8/24/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03809624

A Phase 1a/b Dose-Finding Escalation Study Followed by Expansion Cohorts of NGM120, a GFRAL Antagonist Monoclonal Antibody Blocking GDF15 Signaling, in Subjects With Advanced Solid Tumors and Pancreatic Cancer Using Combination Therapy


Protocol #19-1458, No Longer Enrolling: 12/20/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04068896

A PHASE 2, OPEN-LABEL, MULTI-CENTER STUDY OF AL101 IN PATIENTS WITH ADENOID CYSTIC CARCINOMA (ACC) BEARING ACTIVATING NOTCH MUTATIONS


Protocol #19-2255, No Longer Enrolling: 4/10/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03691207

A Randomized Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Patients with Newly Diagnosed Multiple Myeloma Who are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant (AURIGA)


Protocol #19-6114, No Longer Enrolling: 5/6/2023
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital
More information available at ClinicalTrials.gov: NCT03901963

A Phase 1b Biomarker-Driven Combination Trial of Copanlisib, Olaparib, and MEDI4736 (Durvalumab) in Patients with Advanced Solid Tumors


Protocol #19-1987, No Longer Enrolling: 7/23/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03842228

ACNS1721 - A Phase 2 Study of Veliparib (ABT-888, IND #139199) and Local Irradiation, Followed by Maintenance Veliparib and Temozolomide, in Patients with Newly Diagnosed High-Grade Glioma (HGG) without H3 K27M or BRAFV600E Mutations


Protocol #19-1633, No Longer Enrolling: 11/27/2021
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03581292

The PISCES Study: A Multicenter Phase 2, Open-Label Study of Intratumoral Tavokinogene Telseplasmid (tavo, pIL-12) plus electroporation in Combination with Intravenous Pembrolizumab in Patients with Stage III/IV Melanoma who are Progressing on either Pembrolizumab or Nivolumab Treatment


Protocol #19-1297, No Longer Enrolling: 11/14/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03132675

NRG-LU005: Limited Stage Small Cell Lung Cancer (LS-SCLC): A PHASE III RANDOMIZED STUDY OF CHEMORADIATION VERSUS CHEMORADIATION PLUS ATEZOLIZUMAB


Protocol #19-2514, No Longer Enrolling: 6/28/2022
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03811002

An Open label, Phase I/II study to evaluate the safety and efficacy of Tenalisib (RP6530), a novel PI3K dual inhibitor given in combination with a histone deacetylase (HDAC) inhibitor, Romidepsin in adult patients with relapsed/refractory T-cell Lymphoma


Protocol #19-1431, No Longer Enrolling: 8/20/2020
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03770000

S1826: A PHASE III, RANDOMIZED STUDY OF NIVOLUMAB (OPDIVO) PLUS AVD OR BRENTUXIMAB VEDOTIN (ADCETRIS) PLUS AVD IN PATIENTS (AGE greater than or equal to 12 YEARS) WITH NEWLY DIAGNOSED ADVANCED STAGE CLASSICAL HODGKIN LYMPHOMA


Protocol #19-2950, No Longer Enrolling: 2/3/2024
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03907488

An Investigator-Sponsored, Phase 1/2 trial of the oral XPO1 inhibitor selinexor (KPT-330) in combination with docetaxel for previously treated, advanced KRAS mutant non-small cell lung cancer (NSCLC)


Protocol #18-0554, No Longer Enrolling: 11/19/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03095612

Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, or Other Advanced Solid Tumors: A Phase 1b/2 Study of Cavrotolimod Combined with Pembrolizumab or Cemiplimab


Protocol #19-1074, No Longer Enrolling: 9/9/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03684785

An Open-label, Randomized Phase 3 Study of MK-6482 Versus Everolimus in Participants with Advanced Renal Cell Carcinoma That Has Progressed After Prior PD-1/L1 and VEGF-Targeted Therapies


Protocol #19-2445, No Longer Enrolling: 1/21/2022
Locations: Highlands Ranch Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04195750

ADVL1712: A Feasibility Trial of MLN4924 (Pevonedistat, TAK 924, IND#142772) Given in Combination with Azacitidine, Fludarabine, and Cytarabine, in Children, Adolescents, and Young Adults with Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome


Protocol #19-2163, No Longer Enrolling: 5/19/2021
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03813147

Phase 1b Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Repeated Doses of DB-020 in Patients Receiving Cisplatin


Protocol #19-2560, No Longer Enrolling: 9/4/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04262336

NRG-GI005: Phase II/III Study of Circulating tumOr DNA as a Predictive BiomaRker in Adjuvant Chemotherapy in Patients with Stage IIA Colon Cancer (COBRA)


Protocol #20-0365, No Longer Enrolling: 1/8/2021
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04068103

S1826: A PHASE III, RANDOMIZED STUDY OF NIVOLUMAB (OPDIVO) PLUS AVD OR BRENTUXIMAB VEDOTIN (ADCETRIS) PLUS AVD IN PATIENTS (AGE greater than or equal to 12 YEARS) WITH NEWLY DIAGNOSED ADVANCED STAGE CLASSICAL HODGKIN LYMPHOMA


Protocol #19-2724, No Longer Enrolling: 3/24/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03907488

An open-label, randomised, multicentre, phase III study of irinotecan liposome injection, oxaliplatin, 5-fluorouracil/leucovorin versus nab-paclitaxel plus gemcitabine in subjects who have not previously received chemotherapy for metastatic adenocarcinoma of the pancreas


Protocol #19-6517, No Longer Enrolling: 10/16/2021
Locations: Memorial Hospital Central, Memorial Hospital North, Pikes Peak Regional Hospital
More information available at ClinicalTrials.gov: NCT04083235

A Phase 1, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of PSB205 in Patients with Relapsed/Refractory Solid Tumors


Protocol #19-1069, No Longer Enrolling: 4/19/2022
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03986606

A Multicenter, Double Blind, Randomized,Controlled Study of M7824 with Concurrent Chemoradiation Followed by M7824 versus Concurrent Chemoradiation Plus Placebo Followed by Durvalumab in Participants with Unresectable Stage III Non-small Cell Lung Cancer


Protocol #19-6065, No Longer Enrolling: 4/2/2022
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital
More information available at ClinicalTrials.gov: NCT03840902

A Phase 1/2 First-in-human Study of the Safety and Efficacy of IMC-C103C as a Single Agent and in Combination with Atezolizumab in HLA-A 0201-positive Patients with Advanced MAGE-A4-positive Cancer


Protocol #19-2311, No Longer Enrolling: 11/16/2021
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03973333

NRG-GY022: Assessment of Carboplatin Clearance Predictors: A PK Study on NCI-sponsored Clinical Trials or Standard of Care Treatments Using Carboplatin


Protocol #20-0360, No Longer Enrolling: 5/10/2022
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03997370

A071801: Phase III Trial of Post-Surgical Single Fraction Stereotactic Radiosurgery (SRS) Compared With Fractionated SRS for Resected Metastatic Brain Disease


Protocol #19-2833, No Longer Enrolling: 12/22/2022
Locations: Memorial Hospital Central, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04114981

A Phase 2, Multi-arm, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of IPI-549 Administered in Combination with Front-line Treatment Regimens in Patients with Locally Advanced and/or Metastatic Triple-Negative Breast Cancer or Renal Cell Carcinoma.


Protocol #19-1337, No Longer Enrolling: 4/12/2022
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03961698

A Phase 2b Trial of the MEK 1/2 Inhibitor (MEKi) PD-0325901 in Adult and Pediatric Patients with Neurofibromatosis Type 1 (NF1)-Associated Inoperable Plexiform Neurofibromas (PNs) that are Causing Significant Morbidity


Protocol #19-2270, No Longer Enrolling: 4/12/2023
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03962543

A021703: Randomized double-blind phase III trial of vitamin D3 supplementation in patients with previously untreated metastatic colorectal cancer (SOLARIS)


Protocol #20-0580, No Longer Enrolling: 4/27/2022
Locations: Highlands Ranch Hospital, Lone Tree Medical Center, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04094688

NRG-HN005: A Randomized Phase II/III Trial of De-Intensified Radiation Therapy for Patients with Early-Stage, P16-Positive, Non-Smoking Associated Oropharyngeal Cancer


Protocol #19-2326, No Longer Enrolling: 12/4/2020
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03952585

A Phase 1b/3 Global, Randomized, Double-blind, Placebo-Controlled Trial of Tazemetostat in Combination With Doxorubicin as Frontline Therapy for Advanced Epithelioid Sarcoma


Protocol #19-2564, No Longer Enrolling: 4/7/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04204941

MRI for Cardiotoxicity in Kids (MOCK)


Protocol #19-3023, No Longer Enrolling: 1/7/2021
Locations: Childrens Hospital Colorado, University of Colorado Hospital

A PHASE 2, OPEN-LABEL, SINGLE-ARM, MULTICOHORT, MULTICENTER TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF JCAR017 IN ADULT SUBJECTS WITH RELAPSED OR REFRACTORY INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL) (TRANSCEND FL)


Protocol #19-3011, No Longer Enrolling: 11/17/2023
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04245839

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study of AG-881 in Subjects With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation


Protocol #19-2707, No Longer Enrolling: 12/22/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04164901

Randomized, double-blind, phase 3 study of tucatinib or placebo in combination with ado-trastuzumab emtansine (T-DM1) for subjects with unresectable locally-advanced or metastatic HER2+ breast cancer


Protocol #19-1977, No Longer Enrolling: 12/10/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03975647

A Phase 1b Efficacy and Safety Study of Cofetuzumab Pelidotin (ABBV-647, a PTK7-Targeting Antibody Drug Conjugate) in Subjects with PTK7-Expressing, Recurrent Non-Small Cell Lung Cancer


Protocol #19-2818, No Longer Enrolling: 6/28/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04189614

A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND ANTI TUMOR ACTIVITY OF PF-07062119 IN PATIENTS WITH ADVANCED GASTROINTESTINAL TUMORS


Protocol #19-2761, No Longer Enrolling: 11/11/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04171141

A Phase III, Randomized, Open-label Study to Evaluate Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC)


Protocol #17-1756, No Longer Enrolling: 2/12/2021
Locations: Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03765918

A Phase 3, randomized, placebo-controlled, double-blind clinical study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) to evaluate the safety and efficacy of pembrolizumab and lenvatinib as 1L intervention in a PD-L1 selected population of participants with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) (LEAP-010).


Protocol #19-2721, No Longer Enrolling: 8/2/2022
Locations: Highlands Ranch Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04199104

S1900B, A Phase II Study of Selpercatinib (LOXO-292) in Patients with RET Fusion-Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP Sub-Study)


Protocol #20-0563, No Longer Enrolling: 5/5/2021
Locations: Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04268550

A Phase 1/2, Dose Escalation Study of Intravenous TK216 in Patients with Relapsed or Refractory Ewing Sarcoma


Protocol #16-2158, No Longer Enrolling: 4/12/2022
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02657005

A Randomized, Double-Blind, Phase 3 Study to Evaluate the Activity of Momelotinib (MMB) versus Danazol (DAN) in Symptomatic, Anemic Subjects with Primary Myelofibrosis (PMF), Post-Polycythemia Vera (PV) Myelofibrosis, or Post Essential Thrombocythemia (ET) Myelofibrosis who were Previously Treated with JAK Inhibitor Therapy

To determine the efficacy of MMB versus DAN assessed by improvement in Myelofibrosis Symptom Assessment Form subjects with Primary Myelofibrosis, post-Polycythemia Vera myelofibrosis , or Post Essential Thrombocythemia Myelofibrosis who were previously treated with approved JAK inhibitor therapy.
Protocol #19-2520, No Longer Enrolling: 5/19/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04173494

GBM AGILE Global Adaptive Trial Master Protocol: An International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent GBM (GCAR-7213)


Protocol #19-0744, No Longer Enrolling: 2/9/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03970447

First-In-Human Dose-Escalation Study of STP1002 in Patients with Advanced-Stage Solid Tumors


Protocol #19-3118, No Longer Enrolling: 4/7/2023
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04505839

An open-label, randomized, controlled phase 3 study of enfortumab vedotin in combination with pembrolizumab versus chemotherapy alone in previously untreated locally advanced or metastatic urothelial cancer


Protocol #20-0035, No Longer Enrolling: 10/5/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04223856

A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Transarterial Chemoembolization (TACE) in Combination with either Durvalumab Monotherapy or Durvalumab plus Bevacizumab Therapy in Patients with Locoregional Hepatocellular Carcinoma (EMERALD-1)


Protocol #19-1342, No Longer Enrolling: 4/9/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03778957

S1900C, A Phase II Study of Talazoparib Plus Avelumab in Patients with Stage IV or Recurrent Non-Squamous Non-Small Cell Lung Cancer Bearing Pathogenic STK11 Genomic Alterations (LUNG-MAP Sub-Study)


Protocol #20-0564, No Longer Enrolling: 11/21/2020
Locations: Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04173507

A PHASE 1/2 STUDY OF TPX-0046, A NOVEL ORAL RET/SRC INHIBITOR IN ADULT SUBJECTS WITH ADVANCED/METASTATIC SOLID TUMORS HARBORING ONCOGENIC RET FUSIONS OR MUTATIONS


Protocol #19-2888, No Longer Enrolling: 7/29/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04161391

Identification of Early Cardiac Injury from Radiation Therapy Using Cardiac MRI


Protocol #20-0537, No Longer Enrolling: 1/20/2024
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04486573

A Phase 1b Dose-Finding Study of ARO-HIF2 in Patients with Advanced Clear Cell Renal Cell Carcinoma


Protocol #20-0357, No Longer Enrolling: 10/21/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04169711

EXPANSION AND EVALUATION OF THE UNIVERSITY OF COLORADO STRENGTH (STRIVING TO REACTIVATE ESOPHAGEAL AND GASTRIC HEALTH) PREHABILITATION PROGRAM


Protocol #20-0246, No Longer Enrolling: 11/17/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04520867

A151216 Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST).A screening trial for A081105, E4512 and EA5142


Protocol #18-2625, No Longer Enrolling: 11/11/2022
Locations: Rocky Mountain Regional VA Medical Center
More information available at ClinicalTrials.gov: NCT02194738

S1815: A PHASE III RANDOMIZED TRIAL OF GEMCITABINE, CISPLATIN, AND NAB-PACLITAXEL VERSUS GEMCITABINE AND CISPLATIN IN NEWLY DIAGNOSED, ADVANCED BILIARY TRACT CANCERS


Protocol #19-1588, No Longer Enrolling: 4/7/2021
Locations: Rocky Mountain Regional VA Medical Center
More information available at ClinicalTrials.gov: NCT03768414

S1803: PHASE III STUDY OF DARATUMUMAB/rHuPH20 (NSC- 810307) + LENALIDOMIDE OR LENALIDOMIDE AS POST-AUTOLOGOUS STEM CELL TRANSPLANT MAINTENANCE THERAPY IN PATIENTS WITH MULTIPLE MYELOMA (MM) USING MINIMAL RESIDUAL DISEASE TO DIRECT THERAPY DURATION (DRAMMATIC STUDY)


Protocol #19-1589, No Longer Enrolling: 11/11/2022
Locations: Rocky Mountain Regional VA Medical Center
More information available at ClinicalTrials.gov: NCT04071457

A Randomized Controlled Trial in Patients Undergoing Immediate Implant-Based Breast Reconstruction Utilizing an Enhanced Recovery Pathway Comparing Outcomes and Patient Satisfaction based on Time of Discharge


Protocol #20-1055, No Longer Enrolling: 3/24/2023
Locations: Highlands Ranch Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04558138

A phase 1b/2 dose escalation and expansion study of tucatinib in combination with trastuzumab and oxaliplatin-based chemotherapy for HER2+ gastrointestinal cancers


Protocol #20-1453, No Longer Enrolling: 4/11/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04430738

A Phase I, Multi-Center, Open-Label, Treatment Duration Increment, Expansion, Safety, and Pharmacodynamic Study of CX-4945 Administered Orally Twice Daily to Patients with Advanced Basal Cell Carcinoma


Protocol #19-1711, No Longer Enrolling: 1/20/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03897036

A PHASE II STUDY TO EVALUATE THE SAFETY AND EFFICACY OF OQL011 ON VEGFR INHIBITOR-ASSOCIATED HAND-FOOT SKIN REACTION IN CANCER PATIENTS


Protocol #19-2242, No Longer Enrolling: 3/30/2022
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04088318

Feasibility, Acceptability, and Effects of Combined Aerobic and Resistance Exercise in Breast Cancer Survivors: A Pilot Study (the CARE study)

This is a 12-week combined aerobic and resistance exercise intervention in breast cancer survivors. Before and after the intervention, women will undergo measures of appetite, energy intake, body composition, and resting metabolic rate.
Protocol #19-3032, No Longer Enrolling: 1/8/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04576247

A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Plus ADT Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (KEYNOTE-991)


Protocol #19-2999, No Longer Enrolling: 7/8/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04191096

A Phase 3 Study of Relacorilant in Combination with Nab-Paclitaxel in Patients with Metastatic Pancreatic Ductal Adenocarcinoma (RELIANT)


Protocol #20-0262, No Longer Enrolling: 7/21/2021
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04329949

A Phase 1 study of temozolomide in combination with targeted therapy for NSCLC patients with CNS progression on either osimertinib or lorlatinib


Protocol #20-0138, No Longer Enrolling: 4/26/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04541407

A Phase I study of the ADAM-10 inhibitor, INCB007839 in children with recurrent/progressive high-grade gliomas to target microenvironmental neuroligin-3


Protocol #20-1487, No Longer Enrolling: 5/16/2023
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT04295759

Brigatinib Before Brain Irradiation Trial (B3i Trial): A Phase II Trial of Brigatinib Alone for Brain Metastases from ALK+ Lung Cancer


Protocol #19-2862, No Longer Enrolling: 2/5/2022
Locations: City of Hope Cancer Center, Mayo Clinic, Rochester, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04634110

An Open-label, Multicenter, Multicohort, Phase 2 Study to Evaluate Enfortumab Vedotin in Subjects with Previously Treated Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)


Protocol #20-0216, No Longer Enrolling: 10/26/2022
Locations: Highlands Ranch Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04225117

ADVL1823: Larotrectinib (LOXO-101, NSC# 788607, IND# 141824) for Previously Untreated TRK Fusion Pediatric Solid Tumors and TRK Fusion Relapsed Pediatric Acute Leukemias


Protocol #19-2469, No Longer Enrolling: 6/16/2023
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03834961

A PHASE 1 TRIAL OF THE CD123 X CD3 DART? MOLECULE FLOTETUZUMAB (NSC#808294, IND#145986) IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA


Protocol #20-1106, No Longer Enrolling: 4/12/2022
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT04158739

A Phase Ib/II Study to Evaluate the Safety, Feasibility and Efficacy of Nivolumab or Nivolumab in Combination with Azacitidine in Patients with Recurrent, Resectable Osteosarcoma


Protocol #19-2295, No Longer Enrolling: 1/30/2024
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03628209

The Effects of Acute Resistance Exercise on Energy Balance Regulation among Breast Cancer Survivors

Exercise is important for weight management after treatment for breast cancer. This study aims to assess the effect of exercise on appetite and energy intake after breast cancer treatment. Participants will complete 3-5 study visits at the University of Colorado and receive monetary compensation and instruction on resistance exercise.
Protocol #19-1974, No Longer Enrolling: 7/27/2022
Locations: Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04300478

An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Itacitinib in Combination With Corticosteroids for the Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Pediatric Subjects


Protocol #18-1990, No Longer Enrolling: 10/3/2020
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03497273

Alliance A081105: Randomized Study of Erlotinib or Observation in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC)


Protocol #19-1697, No Longer Enrolling: 11/19/2022
Locations: Rocky Mountain Regional VA Medical Center
More information available at ClinicalTrials.gov: NCT02193282

A Phase 2 Study of Olaparib Monotherapy in Participants with Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer


Protocol #19-2640, No Longer Enrolling: 11/16/2022
Locations: Rocky Mountain Regional VA Medical Center
More information available at ClinicalTrials.gov: NCT03742895

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Study Comparing the Efficacy and Safety of Tislelizumab (BGB-A317) plus Platinum and Fluoropyrimidine Versus Placebo plus Platinum and Fluoropyrimidine as First-Line Treatment in Patients with Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma


Protocol #20-1346, No Longer Enrolling: 10/23/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03777657

EA1181 (CompassHER2 pCR): Preoperative THP and Postoperative HP in Patients Who Achieve a Pathologic Complete Response


Protocol #20-1318, No Longer Enrolling: 10/19/2023
Locations: Cherry Creek Medical Center, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04266249

A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy with Nivolumab versus Placebo after Complete Resection of Stage IIB/C Melanoma (CheckMate 76K)


Protocol #19-1581, No Longer Enrolling: 8/24/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04099251

EA2186: A Randomized Phase II Study of Gemcitabine and Nab-Paclitaxel Compared with 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan in Older Patients with Treatment Naive Metastatic Pancreatic Cancer (GIANT)


Protocol #20-2150, No Longer Enrolling: 10/19/2023
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital
More information available at ClinicalTrials.gov: NCT04233866

A Phase 1, First-in-Human, Safety, Dose Tolerance, Pharmacokinetics, and Pharmacodynamics Study of CPX-POM in Patients with Advanced Solid Tumors


Protocol #20-0727, No Longer Enrolling: 12/3/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03348514

Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of Infigratinib for the Adjuvant Treatment of Subjects with Invasive Urothelial Carcinoma with Susceptible FGFR3 Genetic Alterations (PROOF 302)


Protocol #20-1438, No Longer Enrolling: 10/11/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04197986

A PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ATEZOLIZUMAB GIVEN IN COMBINATION WITH CABOZANTINIB VERSUS CABOZANTINIB ALONE IN PATIENTS WITH INOPERABLE, LOCALLY ADVANCED, OR METASTATIC RENAL CELL CARCINOMA WHO EXPERIENCED RADIOGRAPHIC TUMOR PROGRESSION DURING OR AFTER IMMUNE CHECKPOINT INHIBITOR TREATMENT


Protocol #20-0881, No Longer Enrolling: 12/1/2021
Locations: Highlands Ranch Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04338269

A PHASE 1, OPEN-LABEL, MULTI-CENTER, DOSE-FINDING, PHARMACOKINETIC, SAFETY AND TOLERABILITY STUDY OF PF-07265807 IN PARTICIPANTS WITH SELECTED ADVANCED OR METASTATIC SOLID TUMOR MALIGNANCIES


Protocol #20-1845, No Longer Enrolling: 6/23/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04458259

A MULTI-CENTER, OPEN-LABEL, PHASE 2 STUDY TO EVALUATE SAFETY AND EFFICACY OF U3-1402 IN SUBJECTS WITH ADVANCED OR METASTATIC COLORECTAL CANCER (CRC)


Protocol #20-1267, No Longer Enrolling: 12/17/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04479436

A Phase 1 Multiple-Dose Study to Evaluate the Safety and Tolerability of XmAb?23104 in Subjects with Selected Advanced Solid Tumors (DUET-3)


Protocol #20-1289, No Longer Enrolling: 12/9/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03752398

Ublituximab as initial therapy for treatment-naive follicular or marginal zone lymphoma with response-driven addition of umbralisib for suboptimal response.


Protocol #18-2128, No Longer Enrolling: 2/9/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04508647

Phase Ib/II trial of copanlisib in combination with trastuzumab and pertuzumab after induction treatment of HER2 positive (HER2+ ) metastatic breast cancer (MBC) with PIK3CA mutation or PTEN mutation.


Protocol #19-2988, No Longer Enrolling: 6/8/2022
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04108858

An Open-Label, Multicenter Phase 2 Basket Study to Evaluate the Antitumor Activity and Safety of Lenvatinib in Children, Adolescents, and Young Adults with Relapsed or Refractory Solid Malignancies


Protocol #20-1380, No Longer Enrolling: 9/2/2022
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT04447755

ARST1921 - A Safety, Pharmacokinetic and Efficacy Study of a y-Secretase Inhibitor, Nirogacestat (PF-03084014; IND# 146375), in Children and Adolescents with Progressive, Surgically Unresectable Desmoid Tumors


Protocol #20-2411, No Longer Enrolling: 1/27/2024
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT04195399

AN OPEN-LABEL, SAFETY AND TOLERABILITY PHASE 1b TRIAL OF CAN04, A FULLY HUMANIZED ANTI-IL1RAP MONOCLONAL ANTIBODY, AND PEMBROLIZUMAB IN COMBINATION WITH AND WITHOUT CARBOPLATIN AND PEMETREXED IN SUBJECTS WITH SOLID TUMORS


Protocol #20-0605, No Longer Enrolling: 3/2/2022
Locations: Highlands Ranch Hospital, Lone Tree Medical Center, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04452214

Phase I trial of ribociclib in combination with everolimus and dexamethasone in children and young adults with relapsed acute lymphoblastic leukemia (DF/HCC Protocol#: 18-328)


Protocol #19-0551, No Longer Enrolling: 7/28/2023
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03740334

Patient and caregiver perspectives in bladder cancer diagnosis and treatment


Protocol #19-0987, No Longer Enrolling: 4/13/2021
Locations: Department Specific Free Standing Clinic, University of Colorado Hospital

A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared with Placebo Plus mFOLFOX6 as First-line Treatment of Subjects with Claudin (CLDN)18.2-Positive, HER2- Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma


Protocol #20-0746, No Longer Enrolling: 4/13/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03504397

A Phase 1 First-in-Human Study with ABBV-155 Alone and in Combination with Taxane Therapy in Adults with Relapsed and/or Refractory Solid Tumors


Protocol #18-2417, No Longer Enrolling: 12/3/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03595059

ENVASARC: A PIVOTAL TRIAL OF ENVAFOLIMAB, AND ENVAFOLIMAB IN COMBINATION WITH IPILIMUMAB, IN PATIENTS WITH ADVANCED OR METASTATIC UNDIFFERENTIATED PLEOMORPHIC SARCOMA OR MYXOFIBROSARCOMA WHO HAVE PROGRESSED ON PRIOR CHEMOTHERAPY


Protocol #20-1892, No Longer Enrolling: 9/1/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04480502

A Phase 1 Multi-Targeted Study to Promote Anti-Tumor Immunity in ER Positive, HER2 Negative Advanced Breast Cancer


Protocol #20-0036, No Longer Enrolling: 8/10/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04132817

A Phase 1/2 Study of M3814 (peposertib) in Combination with Hypofractionated Radiotherapy for the Treatment of Locally Advanced Pancreatic Adenocarcinoma


Protocol #20-2093, No Longer Enrolling: 7/21/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04172532

A Phase 1 Study of Aurora Kinase A Inhibitor LY3295668 erbumine as a Single Agent and in Combination in Patients with Relapsed/Refractory Neuroblastoma


Protocol #19-2345, No Longer Enrolling: 9/24/2022
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT04106219

A Phase 2 Study Examining AGEN2034 as a Single-Agent and in Combination with AGEN1884 in Patients with Recurrent, Inoperable Angiosarcoma


Protocol #20-0261, No Longer Enrolling: 5/18/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04607200

A PHASE 1 STUDY OF TJ210001 ADMINISTERED IN SUBJECTS WITH RELAPSED OR REFRACTORY ADVANCED SOLID TUMORS


Protocol #20-2541, No Longer Enrolling: 7/30/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04678921

A Single Arm, Open Label Phase 2 Study of Tucatinib in Combination with Trastuzumab Deruxtecan in Subjects with Previously Treated Unresectable Locally-Advanced or Metastatic HER2+ Breast Cancer


Protocol #20-1667, No Longer Enrolling: 5/26/2023
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04539938

Phase 3 Multicenter, Double-Blind, Placebo-Controlled Trial of Viralym-M (ALVR105) for the Treatment of Patients With Virus-Associated Hemorrhagic Cystitis After Allogeneic Hematopoietic Cell Transplant


Protocol #20-0279, No Longer Enrolling: 1/6/2023
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT04390113

POLATUZUMAB PLUS BENDAMUSTINE PLUS RITUXIMAB (POLA+BR) AS SALVAGE THERAPY PRIOR TO AUTOLOGOUS STEM CELL TRANSPLANT FOR PATIENTS WITH RELAPSED OR PRIMARY REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA


Protocol #19-1195, No Longer Enrolling: 1/30/2021
Locations: Lone Tree Medical Center, University of Colorado Hospital, University of Michigan
More information available at ClinicalTrials.gov: NCT04535102

APEC1621I: NCI-COG PEDIATRIC MATCH (MOLECULAR ANALYSIS FOR THERAPY CHOICE)-PHASE 2 SUBPROTOCOL OF PALBOCICLIB IN PATIENTS WITH TUMORS HARBORING ACTIVATING ALTERATIONS IN CELL CYCLE GENES


Protocol #17-2168I, No Longer Enrolling: 7/27/2022
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03526250

A Phase 1 Study of AGEN1181, an Fc-Engineered Anti-CTLA-4 Monoclonal Antibody as Monotherapy and in Combination with AGEN2034, an Anti-PD-1 Monoclonal Antibody, in Subjects with Advanced Cancer


Protocol #20-2042, No Longer Enrolling: 1/20/2023
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03860272

AN EXPANDED ACCESS, SINGLE-ARM, MULTICENTER STUDY TO PROVIDE AT HOME SUBCUTANEOUS ADMINISTRATION OF PERTUZUMAB AND TRASTUZUMAB FIXED-DOSE COMBINATION (PH FDC SC) FOR PATIENTS WITH HER2-POSITIVE BREAST CANCER DURING THE COVID-19 PANDEMIC


Protocol #20-1830, No Longer Enrolling: 5/11/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04395508

Biomarker Development for Sepsis in Pediatric Oncology Patients


Protocol #20-2374, No Longer Enrolling: 9/2/2022
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT00000000

A Phase I/II Trial of EMB-02, a Bi-specific Antibody Against PD-1 and LAG-3, in Patients with Advanced Solid Tumors

This is a Phase I/II trial with at least 17 patients in the dose escalation phase and 26-45 patients in the Phase II portion of the trial. In the Phase I portion of the trial, patients will receive EMB-02 at doses escalating from 6 to 900 mg IV once weekly. Following the evaluation of initial PK data, the dosing interval might be adjusted (e.g., to every 2 weeks or longer) should there be drug accumulation upon repeated dosing. Any change to dose interval due to safety concerns will involve data review by the Safety Review Committee and a protocol amendment. One treatment cycle is defined as 28 days. The doselimiting toxicity observation period is defined as 28 days.
Protocol #20-2545, No Longer Enrolling: 4/28/2023
Locations: Memorial Hospital Central, Memorial Hospital North
More information available at ClinicalTrials.gov: NCT04618393

A Prospective Registry Study to Evaluate the Effect of the DCISionRT Test on Treatment Decisions in Patients with DCIS Following Breast Conserving Therapy

A Prospective Registry Study to Evaluate the Effect of the DCISionRT Test on Treatment Decisions in Patients with DCIS Following Breast Conserving Therapy
Protocol #20-1420, No Longer Enrolling: 6/30/2021
Locations: Memorial Hospital Central, Memorial Hospital North
More information available at ClinicalTrials.gov: NCT03448926

A Phase 3, Randomized, Double-blind Trial of Nivolumab in Combination with Intravesical BCG versus Standard of Care BCG Alone in Participants with High-risk Non-muscle Invasive Bladder Cancer That Is Persistent or Recurrent After Treatment with BCG


Protocol #20-0003, No Longer Enrolling: 6/4/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04149574

TENACITY: A Phase 2, Multicenter, Open-label, Single-arm Study of AL101 Monotherapy in Patients with Notch-activated Triple Negative Breast Cancer


Protocol #20-1306, No Longer Enrolling: 3/29/2022
Locations: Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04461600

A randomized, double-blind placebo-controlled, Phase 3 study of Debio 1143 in combination with platinum-based chemotherapy and standard fractionation intensity-modulated radiotherapy in patients with locally advanced squamous cell carcinoma of the head and neck, suitable for definitive chemoradiotherapy (TrilynX)


Protocol #20-1907, No Longer Enrolling: 2/14/2023
Locations: Highlands Ranch Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04459715

A Phase 3, Multicenter, Randomized, Open Label Study of Venetoclax and Dexamethasone Compared with Pomalidomide and Dexamethasone in Subjects with t(11;14)-Positive Relapsed or Refractory Multiple Myeloma


Protocol #20-2294, No Longer Enrolling: 11/16/2022
Locations: Rocky Mountain Regional VA Medical Center
More information available at ClinicalTrials.gov: NCT03539744

Prospective Analysis of Circulating Tumor Cells in Patients with Metastatic Prostate Cancer.


Protocol #19-1687, No Longer Enrolling: 5/4/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT00000000

A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants with Melanoma (KEYNOTE-U02): Substudy 02A


Protocol #20-0233, No Longer Enrolling: 4/16/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04305041

A Phase 1a/1b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PY314 as a Single Agent and In Combination with Pembrolizumab in Subjects with Advanced Solid Tumors


Protocol #20-1994, No Longer Enrolling: 6/17/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04691375

Molecular and Genomic Studies of Bone Marrow Failure and Myelodysplastic Syndromes


Protocol #16-1438, No Longer Enrolling: 1/5/2024
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT00000000

A phase 2 study of brentuximab vedotin in combination with pembrolizumab in subjects with metastatic solid malignancies


Protocol #20-2383, No Longer Enrolling: 7/13/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04609566

A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF GDC-9545 COMBINED WITH PALBOCICLIB COMPARED WITH LETROZOLE COMBINED WITH PALBOCICLIB IN PATIENTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER


Protocol #20-0884, No Longer Enrolling: 3/2/2023
Locations: Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04546009

A Multicenter, Open-label, Randomized Phase 2 Study to Compare the Efficacy and Safety of Lenvatinib in Combination with Ifosfamide and Etoposide versus Ifosfamide and Etoposide in Children, Adolescents and Young Adults with Relapsed or Refractory Osteosarcome (OLIE)


Protocol #20-1210, No Longer Enrolling: 4/6/2022
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT04154189

A Phase I Dose Escalation and Dose Expansion and Phase II Monotherapy Open-label, First-in-Human, Multicenter Study of OP-1250 in Adult Subjects with Advanced and/or Metastatic Hormone Receptor (HR)-positive, HER2-negative Breast Cancer


Protocol #20-2279, No Longer Enrolling: 8/19/2023
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04505826

A Phase 1a/1b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PY159 as a Single Agent and In Combination with Pembrolizumab in Subjects with Advanced Solid Tumors


Protocol #20-2818, No Longer Enrolling: 6/15/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04682431

S1929: Phase II Randomized Study of Maintenance Atezolizumab Versus Atezolizumab Combination with Talazoparib in Patients with SLFN11 Positive Extensive Stage Small Cell Lung Cancer (ES-SCLC)


Protocol #20-2084, No Longer Enrolling: 8/23/2022
Locations: Greeley Campus, Harmony Campus, Lone Tree Medical Center, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04334941

Pathogen Identification in Pediatric Hematopoietic Stem Cell Transplant Patients with Suspected Lower Respiratory Tract Infection (PBMTC SUP1601)


Protocol #17-1337, No Longer Enrolling: 4/30/2021
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02926612

An Open-label Phase 1b Study of ORIC-101 in Combination with Anticancer Therapy in Patients with Advanced or Metastatic Solid Tumors


Protocol #20-2733, No Longer Enrolling: 10/13/2021
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03928314

A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants with Melanoma (KEYMAKER-U02): Substudy 02C


Protocol #20-0253, No Longer Enrolling: 9/16/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04303169

A Pilot Study in the Treatment of Refractory Cytomegalovirus (CMV) Infections with Related Donor CMV Specific Cytotoxic T-cells (CTLs) in Children, Adolescents and Young Adult Recipients


Protocol #19-2694, No Longer Enrolling: 12/27/2023
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03266640

A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive Breast Cancer Patients whose Disease has Progressed on Endocrine Therapy in the Metastatic Setting (DESTINY-Breast06)


Protocol #20-2167, No Longer Enrolling: 3/30/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04494425

A091902 - A MULTICENTER PHASE II TRIAL OF PACLITAXEL WITH AND WITHOUT NIVOLUMAB IN TAXANE NAIVE, AND NIVOLUMAB AND CABOZANTINIB IN TAXANE PRETREATED SUBJECTS WITH ANGIOSARCOMA


Protocol #20-3096, No Longer Enrolling: 12/24/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04339738

CONNECT1702: A Phase Ib Study of PTC596 in children with Newly Diagnosed Diffuse Intrinsic Pontine Glioma and High Grade Glioma


Protocol #19-0223, No Longer Enrolling: 2/17/2024
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03605550

A Phase II study of Cabozantinib and Nivolumab in Refractory Metastatic Microsatellite Stable (MSS) Colorectal Cancer


Protocol #21-2687, No Longer Enrolling: 10/12/2023
Locations: Cherry Creek Medical Center, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04963283

A Phase 1/2a Open-Label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmocokinetics of HPN424 in Patients with Advanced Prostate Cancer Refractory to Androgen Therapy


Protocol #20-0281, No Longer Enrolling: 3/16/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03577028

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Enzastaurin Added to Temozolomide During and Following Radiation Therapy in Newly Diagnosed Glioblastoma Patients Who Possess the Novel Genomic Biomarker DGM1


Protocol #20-2697, No Longer Enrolling: 10/13/2022
Locations: Cherry Creek Medical Center, Highlands Ranch Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03776071

A phase II, open label, multi-center trial to determine the efficacy and safety of tisagenlecleucel re-infusion in Pediatric and Adolescent Young Adult (AYA) patients with acute lymphoblastic leukemia experiencing loss of B cell aplasia


Protocol #20-1441, No Longer Enrolling: 9/29/2021
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT04225676

Randomized Multi-Center, Subject and Evaluator Blinded, Parallel-Group Study to Evaluate the Safety and Effectiveness of the Instylla Hydrogel Embolic System (HES) Compared with Standard of Care Transcatheter Arterial Embolization (TAE) / Transcatheter Arterial Chemoembolization (cTACE) for Vascular Occlusion of Hypervascular Tumors; A Pivotal Study


Protocol #20-2933, No Longer Enrolling: 5/2/2023
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04523350

A Phase 2, Open-label, Multicenter Study of TL-895 in Subjects with Relapsed/Refractory Myelofibrosis, Janus Kinase Inhibitor Intolerant Myelofibrosis and Janus Kinase Inhibitor Treatment Ineligible Myelofibrosis

To determine the RP2D and schedule of TL-895 in each cohort. The SRC will determine the RP2D and schedule for Cohorts 1, 2 and 3 based on safety and tolerability data obtained from each arm of that cohort.
Protocol #20-3032, No Longer Enrolling: 7/15/2023
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04655118

A Phase 3 Randomized, Double-blind, Multicenter, Global Study of Monalizumab or Placebo in Combination with Cetuximab in Participants with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated with an Immune Checkpoint Inhibitor


Protocol #20-2644, No Longer Enrolling: 11/16/2022
Locations: Rocky Mountain Regional VA Medical Center
More information available at ClinicalTrials.gov: NCT04590963

A phase III, multicenter, randomized, double blind, placebo-controlled study evaluating the efficacy and safety of canakinumab versus placebo as adjuvant therapy in adult subjects with stages AJCC/UICC v. 8 II-IIIA and IIIB (T greater than 5cm N2) completely resected (R0) non-small cell lung cancer (NSCLC)


Protocol #19-3018, No Longer Enrolling: 3/3/2022
Locations: Rocky Mountain Regional VA Medical Center
More information available at ClinicalTrials.gov: NCT03447769

A Phase 3, Randomized, Open-label Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined with Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence (PIVOT-12)


Protocol #20-1837, No Longer Enrolling: 3/25/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04410445

A Phase 1 Study of FT-7051 in Men with Metastatic Castration-Resistant Prostate Cancer


Protocol #20-2228, No Longer Enrolling: 9/21/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04575766

A Phase 1, First-in-human Study of the Safety, Single- and Multiple-Dose Pharmacokinetics, and Preliminary Activity of Escalating Doses of RBN-2397, an Oral PARP7 Inhibitor, in Patients with Solid Tumors


Protocol #21-3286, No Longer Enrolling: 2/1/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04053673

A RANDOMIZED PHASE III TRIAL COMPARING AXILLARY LYMPH NODE DISSECTION TO AXILLARY RADIATION IN BREAST CANCER PATIENTS (cT1-3 N1) WHO HAVE POSITIVE SENTINEL LYMPH NODE DISEASE AFTER NEOADJUVANT CHEMOTHERAPY


Protocol #UCH13-1230, No Longer Enrolling: 1/19/2022
Locations: Memorial Hospital Central, Memorial Hospital North, Pikes Peak Regional Hospital
More information available at ClinicalTrials.gov: NCT01901094

NRG-GI004 Colorectal Cancer Metastatic dMMR Immuno-Therapy (COMMIT) Study: A Randomized Phase III Study of mFOLFOX6/Bevacizumab Combination Chemotherapy with or Without Atezolizumab or Atezolizumab Monotherapy in the First-Line Treatment of Patients with Deficient DNA Mismatch Repair (dMMR) Metastatic Colorectal Cancer


Protocol #18-0018, No Longer Enrolling: 5/12/2023
Locations: Cherry Creek Medical Center, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02997228

First in Human Phase 1 Trial of ELI-002 Immunotherapy as Treatment for Subjects with Kirsten Rat Sarcoma (KRAS) Mutated Pancreatic Ductal Adenocarcinoma and Other Solid Tumors


Protocol #21-3039, No Longer Enrolling: 4/21/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04853017

EF-32 (TRIDENT): A PIVOTAL RANDOMIZED, OPEN-LABEL STUDY OF OPTUNE? (TTFIELDS, 200KHZ) CONCOMITANT WITH RADIATION THERAPY AND TEMOZOLOMIDE FOR THE TREATMENT OF NEWLY DIAGNOSED GLIOBLASTOMA


Protocol #20-2112, No Longer Enrolling: 1/13/2024
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04471844

A Randomized, Open Label Phase 3 Study Evaluating Safety and Efficacy of Venetoclax in combination with Azacitidine after allogeneic Stem Cell Transplantation in Subjects with Acute Myeloid Leukemia (AML) (VIALE-T)


Protocol #20-1970, No Longer Enrolling: 8/19/2021
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04161885

A Phase 1/2 Open-label, Multi-center Study of the Safety, Pharmacokinetics, and Anti-tumor Activity of LYT-200 Alone and in Combination with Chemotherapy or Anti-PD-1 in Patients with Metastatic Solid Tumors


Protocol #20-2976, No Longer Enrolling: 10/19/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04666688

A Phase 1 Study of RTX-321 for the Treatment of Patients with Advanced Malignancies Associated with Human Papillomavirus-16 Infection


Protocol #21-3219, No Longer Enrolling: 6/30/2022
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04672980

Evaluating the safety of weekly paclitaxel with trastuzumab duocarmazine (SYD985) in patients with metastatic cancer: A Phase I/Ib trial


Protocol #21-3259, No Longer Enrolling: 11/19/2021
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04602117

A randomized, multicenter, double-blind Phase 3 study of amcenestrant (SAR439859) plus palbociclib versus letrozole plus palbociclib for the treatment of patients with ER (+), HER2 (-) breast cancer who have not received prior systemic anti-cancer treatment for advanced disease


Protocol #20-2060, No Longer Enrolling: 11/17/2021
Locations: Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04478266

A Phase 1 First in Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 176 in Subjects With Relapsed or Refractory Multiple Myeloma and Subjects With Relapsed or Refractory Acute Myeloid Leukemia


Protocol #20-1555, No Longer Enrolling: 6/22/2022
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02675452

A PHASE II STUDY OF CHECKPOINT BLOCKADE IMMUNOTHERAPY IN PATIENTS WITH SOMATICALLY HYPERMUTATED RECURRENT WHO GRADE 4 GLIOMA


Protocol #21-3021, No Longer Enrolling: 1/27/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04145115

An Exploratory, Open-label, Multicenter Phase 1b Trial to Evaluate Safety and Efficacy of Sym021 (Anti-PD-1) in Combination with Either Sym022 (Anti-LAG-3) or Sym023 (Anti-TIM-3) in Patients with Advanced Solid Tumor Malignancies


Protocol #20-1878, No Longer Enrolling: 6/15/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04641871

A PHASE 2, MULTICENTER, RANDOMIZED STUDY OF TRASTUZUMAB ERUXTECAN IN HER2-MUTATED METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) [DESTINY-LUNG02]


Protocol #21-2686, No Longer Enrolling: 3/26/2022
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04644237

A Randomized Phase II Trial of Cabozantinib Combined with PD-1 and CTLA-4 Inhibition in Metastatic Soft Tissue Sarcoma


Protocol #21-2726, No Longer Enrolling: 4/27/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04551430

E4512: A Randomized Phase III Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Observation for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein


Protocol #19-1694, No Longer Enrolling: 11/11/2022
Locations: Rocky Mountain Regional VA Medical Center
More information available at ClinicalTrials.gov: NCT02201992

A Phase 1 Study of SRF617 in Patients With Advanced Solid Tumors


Protocol #20-2199, No Longer Enrolling: 10/7/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04336098

A Randomized Phase 3 Study Evaluating Cystectomy with Perioperative Pembrolizumab and Cystectomy with Perioperative Enfortumab Vedotin and Pembrolizumab versus Cystectomy Alone in Participants who are Cisplatin-Ineligible Participants or Decline Cisplatin with Muscle-Invasive Bladder Cancer (KEYNOTE-905/EV-303)


Protocol #20-2607, No Longer Enrolling: 2/3/2023
Locations: Highlands Ranch Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03924895

An Open-label, Fixed-sequence Study to Assess the Effect of Repeated Doses of Capivasertib on the Pharmacokinetics of Oral Midazolam (a CYP450 3A Probe) in Patients With Advanced Solid Tumours Harbouring Alterations in the PI3K/AKT/PTEN Pathway


Protocol #21-3737, No Longer Enrolling: 10/6/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04958226

A randomized registry trial of adjuvant mitotane vs. mitotane with cisplatin/etoposide after primary surgical resection of localized adrenocortical carcinoma with high risk of recurrence (ADIUVO-2 Trial)


Protocol #20-2214, No Longer Enrolling: 8/5/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03583710

Phase 1/1b Study of Bispecific CD19 and CD22 Chimeric Antigen Receptor Co-Expressing T Cells (CD19x22 CAR T) in Adolescent and Adult Patients with Relapsed and/or Refractory B-Non-Hodgkin's Lymphoma (B-NHL)


Protocol #21-2578, No Longer Enrolling: 9/1/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05098613

Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ALVR105 (Viralym-M) Compared to Placebo for the Prevention of AdV, BKV, CMV, EBV, HHV-6, and JCV Infection and/or Disease, in High-Risk Patients After Allogeneic Hematopoietic Cell Transplant

To compare the efficacy of ALVR105 to placebo in the proportion of patients with clinically significant AdV, BKV, CMV, EBV, HHV-6, and/or JCV infection and/or end-organ disease as determined by an independent, blinded Clinical Adjudication Committee (CAC) through Week 14
Protocol #20-2670, No Longer Enrolling: 8/16/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05305040

A Phase 1b/2, Open Label Study of DAY101 Monotherapy or Combination with Other Therapies for Patients with Recurrent, Progressive, or Refractory Solid Tumors Harboring MAPK Pathway Aberrations


Protocol #21-3431, No Longer Enrolling: 8/2/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04985604

A PHASE 2, MULTI-COHORT, OPEN-LABEL STUDY OF INTRATUMORAL TAVOKINOGENE TELSEPLASMID PLUS ELECTROPORATION IN COMBINATION WITH INTRAVENOUS PEMBROLIZUMAB THERAPY WITH OR WITHOUT CHEMOTHERAPY IN PATIENTS WITH INOPERABLE LOCALLY ADVANCED OR METASTATIC TRIPLE NEGATIVE BREAST CANCER.


Protocol #20-2737, No Longer Enrolling: 11/18/2022
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03567720

Phase I/II trial of radiotherapy in combination with Atezolizumab prior to surgical resection for HPV-unrelated squamous cell carcinoma of the head and neck (HNSCC)


Protocol #21-2642, No Longer Enrolling: 9/1/2023
Locations: Highlands Ranch Hospital, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05053737

A Phase 1, Multicenter, Single Agent Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of CPO-100 in Adult Patients with Advanced Solid Tumors


Protocol #21-3561, No Longer Enrolling: 8/9/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04931823

A Phase I-II multicenter, open label trial of H3B-6545, a covalent antagonist of estrogen receptor alpha, in women with locally advanced or metastatic estrogen receptor-positive, HER2 negative breast cancer


Protocol #20-2675, No Longer Enrolling: 5/4/2022
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03250676

A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN328 in Patients with Advanced Cancers Associated with Expression of Delta-Like Canonical Notch Ligand 3 (DLL3) Who Have Failed Standard Available Therapy


Protocol #21-2992, No Longer Enrolling: 11/3/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04471727

An Open-label, Phase 1b/2 Study to Evaluate the Safety and Efficacy of Fruquintinib in Combination with Tislelizumab in Patients with Advanced Solid Tumors OLD TITLE: pen-label, Phase 1b/2 Study to Evaluate the Safety and Efficacy of Fruquintinib in Combination with Tislelizumab in Patients with Advanced Triple Negative Breast Cancer


Protocol #21-3064, No Longer Enrolling: 2/15/2023
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04577963

A Phase 2 Study of Belinostat and SGI-110 (Guadecitabine) or ASTX727 for the Treatment of Unresectable and Metastatic Conventional Chondrosarcoma


Protocol #20-3007, No Longer Enrolling: 3/3/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04340843

A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY OF ENCORAFENIB AND BINIMETINIB PLUS PEMBROLIZUMAB VERSUS PLACEBO PLUS PEMBROLIZUMAB IN PARTICIPANTS WITH BRAF V600E/K MUTATION-POSITIVE METASTATIC OR UNRESECTABLE LOCALLY ADVANCED MELANOMA


Protocol #21-3370, No Longer Enrolling: 2/15/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04657991

PHASE 1/2a DOSE ESCALATION AND EXPANSION STUDY EVALUATING SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMICS AND ANTI-TUMOR ACTIVITY OF PF-06873600 AS A SINGLE AGENT AND IN COMBINATION WITH ENDOCRINE THERAPY


Protocol #21-3529, No Longer Enrolling: 8/9/2022
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03519178

A Phase 1b/2, Randomized, Controlled, Open-Label Study Evaluating the Safety and Efficacy of ABBV-927 Administered in Combination with Modified FOLFIRINOX (mFFX) With or Without Budigalimab compared to mFFX in Subjects with Untreated Metastatic Pancreatic Adenocarcinoma


Protocol #21-3617, No Longer Enrolling: 5/27/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04807972

Tamibarotene in Combination with Venetoclax and Azacitidine in Previously Untreated Adult Patients Selected for RARA-positive AML Who Are Ineligible for Standard Induction Therapy


Protocol #21-3416, No Longer Enrolling: 11/16/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04905407

Phase II Study of Radiotherapy in Combination with Chemotherapy and Immunotherapy in Patients with PD-L1-Positive Metastatic Triple-Negative Breast Cancer


Protocol #21-3117, No Longer Enrolling: 12/2/2022
Locations: Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05233696

Detection of resistance mechanisms in cerebrospinal fluid for EGFR-mutant, ALK- and ROS1-rearranged non-small cell lung cancer patients with central nervous system (CNS) progression after evidence of prior CNS benefit on relevant tyrosine kinase inhibitors


Protocol #20-1193, No Longer Enrolling: 9/16/2022
Locations: Georgetown University, University of Colorado Hospital, USC (Norris Hospital)
More information available at ClinicalTrials.gov: NCT05116618

A Phase 1/2 Open-label Study Investigating the Safety, Tolerability and Efficacy of ASP0739 as a Single Agent and in Combination with Pembrolizumab in Patients with Advanced Solid Tumors known to Express NY-ESO-1


Protocol #21-4045, No Longer Enrolling: 3/4/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04939701

NRG-BN010: A SAFETY RUN-IN AND PHASE II STUDY EVALUATING THE EFFICACY, SAFETY, AND IMPACT ON THE TUMOR MICROENVIRONMENT OF THE COMBINATION OF TOCILIZUMAB, ATEZOLIZUMAB, AND FRACTIONATED STEREOTACTIC RADIOTHERAPY IN RECURRENT GLIOBLASTOMA


Protocol #21-4799, No Longer Enrolling: 8/4/2022
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04729959

Single-Arm, Phase 2 Study of Valemetostat Tosylate Monotherapy in Subjects with Relapsed/Refractory Peripheral T-Cell Lymphoma

To estimate the objective response rate (ORR) with valemetostat tosylate monotherapy treatment in relapsed/refractory peripheral T-cell lymphoma (R/R PTCL, including R/R adult T-cell leukemia/lymphoma (ATL). Subjects with R/R ATL are to be enrolled in a separate cohort and will be analyzed independently.
Protocol #21-3415, No Longer Enrolling: 7/20/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04703192

An Open-Label Phase 1b/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Antitumor Activity of TAK-573 as a Single Agent and in Combination with Pembrolizumab in Adult Patients with Advanced or Metastatic Solid Tumors

An Open-Label Phase 1b/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Antitumor Activity of TAK-573 as a Single Agent and in Combination with Pembrolizumab in Adult Patients with Advanced or Metastatic Solid Tumors
Protocol #21-4364, No Longer Enrolling: 5/24/2023
Locations: Memorial Hospital Central, Memorial Hospital North
More information available at ClinicalTrials.gov: NCT04157517

A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of NC318 in Subjects with Advanced or Metastatic Solid Tumors


Protocol #21-4329, No Longer Enrolling: 11/16/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03665285

Extended Access of Momelotinib for Subjects with Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)

The primary objective of this study is to provide extended access to momelotinib (MMB) and assess long-term safety in 4 cohorts of subjects who are currently receiving treatment with MMB and have not experienced progression of disease:  Cohort 1: Study GS-US-352-0101, subjects with primary myelofibrosis (PMF) or post-polycythemia vera/essential thrombocythemia myelofibrosis (post-PV/ET MF)  Cohort 2: Study GS-US-352-1214, subjects with PMF or post-PV/ET MF  Cohort 3: Study GS-US-352-1154, subjects with PMF or post-PV/ET MF  Cohort 4: Study SRA-MMB-301, subjects with PMF or post-PV/ET MF
Protocol #21-4793, No Longer Enrolling: 4/15/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03441113

Phase II Study of cemiplimab, an anti-PD-1 monoclonal antibody, and ISA101b vaccine in patients with recurrent/metastatic HPV16-positive Oropharyngeal Cancer who have experienced disease progression with prior anti-PD-1 therapy


Protocol #21-3833, No Longer Enrolling: 7/19/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04398524

CC-486 and Venetoclax for Acute Myeloid Leukemia

To determine the maximum tolerated or recommended dose of CC-486 in combination with venetoclax
Protocol #20-1319, No Longer Enrolling: 1/9/2024
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05287568

APEC1621C: NCI-COG PEDIATRIC MATCH (MOLECULAR ANALYSIS FOR THERAPY CHOICE)-PHASE 2 SUBPROTOCOL OF TAZEMETOSTAT IN PATIENTS WITH TUMORS HARBORING ALTERATIONS IN EZH2 OR MEMBERS OF THE SWI/SNF COMPLEX


Protocol #17-2168C, No Longer Enrolling: 3/5/2022
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03213665

MAGNETISMM-9 A PHASE 1/2, OPEN-LABEL, MULTICENTER STUDY TO EVALUATE A DOSING REGIMEN WITH TWO STEP-UP PRIMING DOSES AND LONGER DOSING INTERVALS AND ELRANATAMAB IN COMBINATION WITH DEXAMETHASONE IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA


Protocol #21-4016, No Longer Enrolling: 8/4/2023
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital
More information available at ClinicalTrials.gov: NCT05014412

A Phase 2 non-randomized, open-label, multi-cohort, multi-center study assessing the clinical benefit of SAR444245 (THOR-707) combined with other anticancer therapies for the treatment of participants with head and neck squamous cell carcinoma (HNSCC)


Protocol #21-4146, No Longer Enrolling: 10/28/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05061420

A Phase 1b, Open-Label, Dose-Escalation, Dose-Expansion Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Orally Administered SM08502 Combined with Hormonal Therapy or Chemotherapy in Subjects with Advanced Solid Tumors


Protocol #21-4716, No Longer Enrolling: 10/11/2022
Locations: Highlands Ranch Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05084859

A phase I study with an expansion cohort of duvelisib and nivolumab in mycosis fungoides (MF) and Sezary syndrome (SS)


Protocol #21-4327, No Longer Enrolling: 12/6/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04652960

A Phase I, Open-Label, Multicenter Study of FT538 in Combination with Monoclonal Antibodies in Subjects with Advanced Solid Tumors


Protocol #21-4178, No Longer Enrolling: 10/1/2022
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05069935

A Multicenter, Open-label, Phase 1a/b Study of HC-7366 in Subjects With Advanced Solid Tumors


Protocol #21-4887, No Longer Enrolling: 2/1/2024
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05121948

3CI Study: Childhood Cancer Combination Immunotherapy. Phase 1b and Expansion Study of Nivolumab Combination Immunotherapy in Children, Adolescent and Young Adult (CAYA) Patients with Relapsed/Refractory Hypermutant Cancers

TMB is the total amount of genetic changes or “mutations” found in tumor cells. Some studies in adults with cancer have shown that patients with a higher TMB are more likely to respond to immunotherapy drugs. Participants who have an elevated TMB may be eligible to take part in the treatment portion of this study (Part 2) and get a combination of two immunotherapy drugs. Primary: To confirm the safety and tolerability of nivolumab-based combination therapy. Secondary: To assess objective overall response rate (ORR) to the nivolumab-based combination therapy.
Protocol #21-2688, No Longer Enrolling: 8/9/2022
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT04500548

A Phase 2, Open-label Study to Evaluate the Safety and Efficacy of MK- 7684A (MK-7684 [Vibostolimab] with MK-3475 [Pembrolizumab] Coformulation) in Participants with Relapsed or Refractory Hematological Malignancies

Part 1: To determine the safety and tolerability of MK-7684A (Cohorts A to F)
Protocol #21-4054, No Longer Enrolling: 7/20/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05005442

A Randomized Phase 2 Study of Combination Atezolizumab and CDX-1127 (Varlilumab) With or Without Addition of Cobimetinib in Previously Treated Unresectable Biliary Tract Cancers


Protocol #22-0030, No Longer Enrolling: 8/2/2022
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04941287

A Phase II Study of Talimogene laherparepvec Followed by Talimogene laherparepvec + Nivolumab in Refractory T Cell and NK Cell Lymphomas, Cutaneous Squamous Cell Carcinoma, Merkel Cell Carcinoma, and Other Rare Skin Tumors


Protocol #18-1265, No Longer Enrolling: 7/21/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02978625

A Phase 2 Study to Evaluate the Efficacy and Safety of Pembrolizumab plus Investigational Agents in Combination with Etoposide and Cisplatin or Carboplatin for the First-Line Treatment of Participants with Extensive-Stage Small Cell Lung Cancer (KEYNOTE-B99)


Protocol #21-3726, No Longer Enrolling: 3/1/2023
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04924101

Phase 1b/2, Open-Label, Multicenter Study of ERAS-007 in Combination with Other Anti-Cancer Therapies in Patients with Advanced Non-Small-Cell Lung Cancer (HERKULES-2)


Protocol #21-4032, No Longer Enrolling: 1/18/2023
Locations: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04959981

Multicenter, randomized, parallel group, phase 2 study to establish the efficacy and safety of combinations of CBP501, cisplatin, and nivolumab for greater than or equal to 3rd line treatment of patients with exocrine pancreatic cancer and WBC <10,000/mm3 at screening


Protocol #21-5119, No Longer Enrolling: 12/14/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04953962

A RANDOMIZED PHASE 3 DOUBLE-BLINDED STUDY COMPARING THE EFFICACY AND SAFETY OF NIRAPARIB TO PLACEBO IN PARTICIPANTS WITH EITHER HER2-NEGATIVE BRCA-MUTATED OR TRIPLE-NEGATIVE BREAST CANCER WITH MOLECULAR DISEASE BASED ON PRESENCE OF CIRCULATING TUMOR DNA AFTER DEFINITIVE THERAPY (ZEST)


Protocol #21-3616, No Longer Enrolling: 4/28/2023
Locations: Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04915755

A phase II study (with safety run-in) of evorpacept (ALX148) in combination with cetuximab and pembrolizumab in patients with refractory microsatellite stable metastatic colorectal cancer


Protocol #22-0110, No Longer Enrolling: 5/10/2023
Locations: Rutgers Cancer Institute of New Jersey, Swedish Cancer Center, University of Arizona Cancer Center, University of Colorado Hospital, University of Kansas Cancer Center
More information available at ClinicalTrials.gov: NCT05167409

A Phase 3, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants with Muscle-invasive Bladder Cancer (KEYNOTE-B15 / EV-304


Protocol #21-3677, No Longer Enrolling: 11/10/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04700124

S2011: RANDOMIZED PHASE II TRIAL OF GEMCITABINE, AVELUMAB AND CARBOPLATIN VS. NO NEOADJUVANT THERAPY PRECEDING SURGERY FOR CISPLATIN-INELIGIBLE MUSCLE-INVASIVE UROTHELIAL CARCINOMA: SWOG GAP TRIAL


Protocol #22-0172, No Longer Enrolling: 7/13/2023
Locations: Highlands Ranch Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04871529

A Phase I Study of FT516 as Monotherapy in Relapsed/Refractory Acute Myelogenous Leukemia and in Combination with Monoclonal Antibodies in Relapsed/Refractory B-Cell Lymphoma

To determine the RP2D for FT516 as monotherapy (r/r AML), and in combination with rituximab or obinutuzumab (r/r B-cell lymphoma) To evaluate the safety and tolerability of FT516 as monotherapy following CY/FLU conditioning (r/r AML), and in combination with rituximab or obinutuzumab following CY/FLU conditioning (r/r B-cell lymphoma) To evaluate the safety and tolerability of FT516 in combination with rituximab or obinutuzumab following bendamustine conditioning (r/r B-cell lymphoma)
Protocol #21-3986, No Longer Enrolling: 12/7/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04023071

A Randomized, Double-Blind, Phase 3 Study of MK-7684A Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy as First Line Treatment for Participants With Metastatic Non-Small Cell Lung Cancer


Protocol #22-0006, No Longer Enrolling: 4/29/2023
Locations: Memorial Hospital Central, Memorial Hospital North
More information available at ClinicalTrials.gov: NCT05226598

NRG-GY012: A Randomized Phase II Study Comparing Single-Agent Olaparib, Single Agent Cediranib, and the Combination of Cediranib/Olaparib in Women with Recurrent, Persistent or Metastatic Endometrial Cancer.


Protocol #18-2281, No Longer Enrolling: 7/1/2023
Locations: Harmony Campus, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03660826

A Phase 1/2, First-in-Human, Multicenter, Open-Label Study of SQZ-eAPC-HPV as Monotherapy and in Combination with Immune Checkpoint Inhibitor(s) in Patients with HPV16+ Recurrent, Locally Advanced, or Metastatic Solid Tumors


Protocol #22-0228, No Longer Enrolling: 10/4/2023
Locations: CTRC Inpatient, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05357898

A Phase 1/ 2 Study of BAY 1895344 (elimusertib, IND#152153, NSC#810486) in Pediatric Patients with Relapsed or Refractory Solid Tumors

BAY 1895344 (elimusertib) is experimental because it has not been proven to work in a situation like yours. We are using BAY 1895344 (elimusertib) because it seems to work against cancer in test tubes and animals. BAY 1895344 (elimusertib) has been used in adults, but there is a lot that we do not know about BAY 1895344 (elimusertib) yet in children. This is a Phase 1/2 study because because the goal is to find the highest dose of BAY 1895344 (elimusertib) that we can give safely. We are testing new experimental drugs such as BAY 1895344 (elimusertib) in the hopes of finding a treatment that may be effective against cancer that has come back or that has not responded to standard therapy. This study looks at how well BAY 1895344 (elimusertib) works when given to children and young adults with refractory or recurrent solid tumors and lymphomas which contain specific genetic changes.
Protocol #21-5013, No Longer Enrolling: 3/29/2023
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT05071209

A Multicenter, Double-blind, Randomized Phase 3 Study to Compare the Efficacy and Safety of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab, in the Adjuvant Treatment of Clear Cell Renal Cell Carcinoma (ccRCC) Post Nephrectomy (MK-6482-022)


Protocol #21-5088, No Longer Enrolling: 9/14/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05239728

A Multicenter, Open-label, Phase 2 Study of Imprime PGG and Pembrolizumab in Patients with Metastatic Breast Cancer (mBCA) Who Have Progressed Through Prior Hormonal Therapy


Protocol #21-5099, No Longer Enrolling: 1/14/2023
Locations: CTRC Inpatient, Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05159778

Phase 2 Study of Rogaratinib (BAY 1163877) in the Treatment of Patients with Sarcoma Harboring Alterations in Fibroblast Growth Factor Receptor (FGFR) 1-4 and SDH-deficient Gastrointestinal Stromal Tumor (GIST)


Protocol #22-0611, No Longer Enrolling: 9/8/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04595747

A Phase 1 Study of SGN-B7H4V in Advanced Solid Tumors


Protocol #22-0359, No Longer Enrolling: 8/23/2023
Locations: CTRC Inpatient, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05194072

TCR alpha/beta and CD19-depleted Allogeneic Hematopoietic Cell Transplant for Malignant and Non-Malignant Hematologic Disease

This is a single-site, open label, interventional, non-randomized, phase II trial of TCR alpha-beta/CD19 deplete allogeneic HCT as donor source and sole GVHD prophylaxis in pediatric patients with either malignant or non-malignant hematologic disease who are eligible for allogeneic HCT, but lack a HLA-matched sibling donor.
Protocol #20-2336, No Longer Enrolling: 2/14/2024
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT05288595

A Phase 1, Open-Label, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of IMM2902 in Patients with HER2-Expressing Advanced Solid Tumors


Protocol #22-0510, No Longer Enrolling: 1/27/2024
Locations: CTRC Inpatient, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05076591

A Phase 1, Open-Label, First in Human, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZX-4081 in Patients with Advanced Solid Tumors


Protocol #22-0318, No Longer Enrolling: 6/20/2023
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05118841

A Phase 3 Study of CG0070 in Patients with Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)


Protocol #21-4846, No Longer Enrolling: 7/27/2023
Locations: CTRC Inpatient, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04452591

An Open-label, Multicenter, Phase 2 Study of Sacituzumab Govitecan Combinations in First-line Treatment of Patients with Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC) Without Actionable Genomic Alterations


Protocol #22-0234, No Longer Enrolling: 7/21/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05186974

First in Human Phase 1/2 Trial of ELI-002 7P Immunotherapy as Treatment for Subjects with Kirsten Rat Sarcoma (KRAS)/Neuroblastoma RAS viral oncogene homolog (NRAS) Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors


Protocol #22-0293, No Longer Enrolling: 1/10/2024
Locations: CTRC Inpatient, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05241873

Phase Ib Study of Brigatinib Plus Bevacizumab in Patients with ALK-rearranged Non-Small Cell Lung Cancer (NSCLC)


Protocol #21-4776, No Longer Enrolling: 2/9/2024
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04227028

S1937: A PHASE III RANDOMIZED TRIAL OF ERIBULIN (NSC #707389) WITH OR WITHOUT GEMCITABINE VERSUS STANDARD OF CARE (PHYSICIAN'S CHOICE) FOR TREATMENT OF METASTATIC UROTHELIAL CARCINOMA REFRACTORY TO, OR INELIGIBLE FOR, ANTI PD1/PDL1 THERAPY


Protocol #22-0927, No Longer Enrolling: 5/31/2023
Locations: Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04579224

A Phase 1/2 Open-Label, Multicenter Study to Characterize the Safety and Tolerability of CFT8634 in Subjects With Locally Advanced or Metastatic SMARCB1-Perturbed Cancers, Including Synovial Sarcoma and SMARCB1-Null Tumors


Protocol #22-0052, No Longer Enrolling: 11/15/2023
Locations: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05355753

A PHASE 1/2 OPEN-LABEL, DOSE-ESCALATION AND DOSE EXPANSION STUDY TO DETERMINE A CENTRAL NERVOUS SYSTEM DOSE AND SCHEDULE OF TEPOTINIB ALONE OR IN COMBINATION WITH OTHER RELEVANT TYROSINE KINASE INHIBITORS IN ADULT PARTICIPANTS WITH MET-DRIVEN NSCLC


Protocol #21-4347, No Longer Enrolling: 4/5/2023
Locations: CTRC Inpatient, Georgetown University, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04739358

A post-trial access roll-over study to allow access to ribociclib (LEE011) for patients who are on ribociclib treatment in Novartis-sponsored study


Protocol #22-0532, No Longer Enrolling: 10/13/2022
Locations: Harmony Campus
More information available at ClinicalTrials.gov: NCT05161195

A Randomized, Double-Blind, Phase 3 Study of Pemrbolizumab/Vibostolimab (MK-7684A) in combination with Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants with Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)


Protocol #22-0577, No Longer Enrolling: 4/25/2023
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital
More information available at ClinicalTrials.gov: NCT05226598

Pivotal Study of the NanoKnife System for Ablation of Prostate Tissue in an Intermediate-Risk Patient Population

The purpose of this study is to evaluate the safety and effectiveness of the NanoKnife System to ablate prostate tissue when used in an intermediate-risk patient population. This study will involve 118 subjects in the US who meet the intermediate-risk criteria defined by this protocol. The subjects' prostate lesions, the locations of which will be determined by ultrasound-guided transperineal or transrectal prostate biopsy, will be targeted for treatment with the NanoKnife System. The primary objective of this the study will be to evaluate the NanoKnife System's ablation effectiveness by measuring the negative in-field biopsy rate at 12 months, and the procedural and post-treatment safety of the NanoKnife System via incidence and severity of adverse events through 12 months. The secondary objective of this study is to evaluate urinary and erectile function after NanoKnife System treatment using validated subject questionnaires, and to evaluate pre- and post-treatment changes in PSA and prostate volume. Other secondary outcomes include the effectiveness of the NanoKnife System by assessing the need for secondary or adjuvant treatment and health-related quality of life evaluated using validated subject questionnaires. This group of subjects will be followed for safety and efficacy for 12 months, which includes follow-up checks. During this time, subjects will receive treatment with the NanoKnife and then standard of care treatment for prostate cancer. In this study, blood and urine samples will be collected for safety tests. During the study, the amount of blood drawn will be within the standard accepted guidelines for research purposes. In addition, an MRI and/or ultrasound exam will be performed at some visits, and subjects will undergo a follow-up prostate biopsy at Visit 8 (twelve months), or if a recurrence of cancer is suspected. The sponsor will have access to subject medical records for up to four years after their participation in the study is complete, in order to continue to study the long-term effects of the NanoKnife treatment.
Protocol #21-2798, No Longer Enrolling: 7/29/2023
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04972097

A Phase 1 Study of AGEN2373, an Anti-CD137 Monoclonal Antibody, as Monotherapy and in Combination with AGEN1181, an Fc-Engineered Anti-CTLA-4 Monoclonal Antibody, in Patients with Advanced Cancer


Protocol #22-0326, No Longer Enrolling: 8/2/2023
Locations: CTRC Inpatient, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04121676

CYCLONE 3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abemaciclib in Combination with Abiraterone plus Prednisone in Men with High-Risk Metastatic Hormone- Sensitive Prostate Cancer


Protocol #22-0782, No Longer Enrolling: 11/23/2023
Locations: Memorial Hospital Central, Memorial Hospital North
More information available at ClinicalTrials.gov: NCT05288166

A Phase I/II Study of AMG 510 in Combination with MVASI in Patients with Advanced, Unresectable or Metastatic KRAS G12C Mutant NSCLC with Asymptomatic Brain Metastasis


Protocol #22-0099, No Longer Enrolling: 2/16/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05180422

A PHASE 1, OPEN-LABEL STUDY OF THE SAFETY, TOLERABILITY, AND PRELIMINARY CLINICAL ACTIVITY OF ALLOGENEIC INVARIANT NATURAL KILLER T (INKT) CELLS (AGENT-797) AS A SINGLE AGENT AND IN COMBINATION WITH APPROVED IMMUNE CHECKPOINT INHIBITORS IN SUBJECTS WITH RELAPSED/REFRACTORY SOLID TUMORS


Protocol #22-0878, No Longer Enrolling: 2/13/2024
Locations: CTRC Inpatient, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05108623

A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy with Nivolumab + Relatlimab Fixed-dose Combination versus Nivolumab Monotherapy after Complete Resection of Stage III-IV Melanoma


Protocol #22-0795, No Longer Enrolling: 11/11/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05002569

A Phase II/III Study of N-803 (ALT-803) plus Pembrolizumab versus Standard of Care in Participants with Stage IV or Recurrent Non-Small Cell Lung Cancer Previously Treated with Anti-PD-1 or Anti-PD-L1 Therapy (Lung-MAP Non-Match Sub-Study)


Protocol #22-1179, No Longer Enrolling: 3/14/2023
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital
More information available at ClinicalTrials.gov: NCT05096663

Protocol Addendum J1S-MC-JV01(d) A Randomized, Open-Label Phase 1/2 Study Evaluating Ramucirumab in Pediatric Patients and Young Adults with Relapsed, Recurrent, or Refractory Desmoplastic Small Round Cell Tumor

The main reason for this study is to help in answering the following research questions: - Whether ramucirumab with cyclophosphamide and vinorelbine can help children and young adults with desmoplastic small round cell tumor (DSRCT). - The safety of ramucirumab and any side effects you might have when you take it along with cyclophosphamide and vinorelbine. This study is being done to learn more about the investigational drug, ramucirumab, for the treatment of DSRCT. Investigational means that the drug being tested has not been approved for routine clinical use or for the use described in this study by the United States Food and Drug Administration (FDA).
Protocol #20-2685A, No Longer Enrolling: 12/23/2022
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT04145349

A Phase 2/3 Study to Evaluate the Efficacy and Safety of Unesbulin in Unresectable or Metastatic, Relapsed or Refractory Leiomyosarcoma


Protocol #22-0889, No Longer Enrolling: 1/19/2024
Locations: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03761095

A RANDOMIZED, OPEN-LABEL, PHASE 2 STUDY OF BOTENSILIMAB (AGEN1181) AS MONOTHERAPY AND IN COMBINATION WITH BALSTILIMAB (AGEN2034) OR INVESTIGATOR'S CHOICE STANDARD OF CARE (REGORAFENIB OR TRIFLURIDINE AND TIPIRACIL) FOR THE TREATMENT OF REFRACTORY METASTATIC COLORECTAL CANCER


Protocol #22-2362, No Longer Enrolling: 10/10/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05608044

AUGMENT-102: A Phase 1, Open-label, Dose-escalation Study to Evaluate Safety, Tolerability and Preliminary Anti-Leukemic Activity of SNDX-5613 in Combination with Chemotherapy in Patients with Relapsed/Refractory Leukemias Harboring a KMT2A/MLL Gene Rearrangement or Nucleophosmin 1 Mutation (mNPM1)


Protocol #21-4798, No Longer Enrolling: 2/17/2024
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT05326516

CYCLONE 3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abemaciclib in Combination with Abiraterone plus Prednisone in Men with High-Risk Metastatic Hormone-Sensitive Prostate Cancer


Protocol #22-0541, No Longer Enrolling: 9/1/2023
Locations: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05288166

The influence of excess adiposity on cardiorespiratory, insulin-like growth factor, and metabolic responses to a standardized aerobic exercise program in cancer survivors


Protocol #22-0356, No Longer Enrolling: 6/17/2023
Locations: Anschutz Health and Wellness, Outpatient CTRC
More information available at ClinicalTrials.gov: NCT05558384

CYCLONE 3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abemaciclib in Combination with Abiraterone plus Prednisone in Men with High-Risk Metastatic Hormone-Sensitive Prostate Cancer


Protocol #22-0213, No Longer Enrolling: 8/19/2023
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital
More information available at ClinicalTrials.gov: NCT05288166

S2013: IMMUNE CHECKPOINT INHIBITOR TOXICITY (I-CHECKIT): A PROSPECTIVE OBSERVATIONAL STUDY


Protocol #22-2134, No Longer Enrolling: 1/27/2024
Locations: Rocky Mountain Regional VA Medical Center
More information available at ClinicalTrials.gov: NCT04871542

ACNS1931-A Phase 3 Study of Selumetinib (NSC# 748727, IND# 77782) or Selumetinib in Combination with Vinblastine for non- NF1, non-TSC Patients with Recurrent or Progressive Low-Grade Gliomas (LGGs) Lacking BRAFV600E or IDH1 Mutations


Protocol #22-0358, No Longer Enrolling: 1/27/2024
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT04576117

S2101, "Biomarker Stratified CaboZantinib (NSC#761968) and NivOlumab (NSC#748726) (BiCaZO) - A Phase II Study of Combining Cabozantinib and Nivolumab in Participants with Advanced Solid Tumors (IO refractory Melanoma or HNSCC) Stratified by Tumor Biomarkers - an immunoMATCH Pilot Study"


Protocol #23-0431, No Longer Enrolling: 6/23/2023
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital
More information available at ClinicalTrials.gov: NCT05136196

Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Study of Investigational Agents With or Without Pembrolizumab in Participants with PD-1/L1 Refractory Locally Advanced or Metastatic Urothelial Carcinoma (KEYMAKER-U04): Substudy 04A


Protocol #22-2055A, No Longer Enrolling: 5/13/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05562830

(Cohort K) TUMOR-AGNOSTIC PRECISION IMMUNOONCOLOGY AND SOMATIC TARGETING RATIONAL FOR YOU (TAPISTRY) PHASE II PLATFORM TRIAL


Protocol #20-2114K, No Longer Enrolling: 2/17/2024
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT00000000

OPTIMUM Low Grade Glioma Research: Comparing Stakeholder Engagement Methods


Protocol #20-1001, No Longer Enrolling: 7/26/2023
Locations: Department Specific Free Standing Clinic

A Mixed-Methods Analysis of Hope Among Hispanic American Adolescents and Young Adults (AYAs) During Early Cancer Survivorship


Protocol #21-4823, No Longer Enrolling: 9/10/2023
Locations: Department Specific Free Standing Clinic
More information available at ClinicalTrials.gov: NCT00000000

Real-world efficacy and safety, patterns of resistance and clinical progression among patients with Non-Small Cell Lung Cancer harboring EGFR exon 20 insertion mutations: An ATOMIC Analysis


Protocol #23-0612, No Longer Enrolling: 11/14/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT00000000

AN OPEN-LABEL, 3-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) MONOTHERAPY AND ELRANATAMAB + DARATUMUMAB VERSUS DARATUMUMAB + POMALIDOMIDE + DEXAMETHASONE IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST 1 PRIOR LINE OF THERAPY INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR


Protocol #23-0848, No Longer Enrolling: 12/1/2023
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital
More information available at ClinicalTrials.gov: NCT05020236

A Phase 1, Multicenter, Open-Label, Dose Escalation, and Dose Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of DCBY02 as Monotherapy in Patients with Advanced or Metastatic Solid Tumors.


Protocol #22-1729, No Longer Enrolling: 12/16/2023
Locations: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05496595

SNDX-5613-0707: Expanded Access Program for SNDX-5613 in Patients with Relapsed/Refractory Acute Leukemias with Genetic Alterations Associated with HOXA Overexpression


Protocol #23-1922, No Longer Enrolling: 10/27/2023
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT00000000

A Phase II Study of FOLFIRINOX Combined with the Glycogen Synthase Kinase-3 Beta (GSK-3 Beta) Inhibitor Elraglusib and the Transforming Growth Factor-B (TGF-B) Inhibitor Losartan in Patients with Untreated Metastatic Pancreas Adenocarcinoma.


Protocol #22-2372, No Longer Enrolling: 12/7/2023
Locations: CU-RIC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05077800

ANHL2121 - Phase 2 Study of Tovorafenib (DAY101) in Relapsed and Refractory Langerhans Cell Histiocytosis


Protocol #23-0910, No Longer Enrolling: 12/13/2023
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT05828069

ACNS2031- A Phase 3 Study of Sodium Thiosulfate for Reduction of Cisplatin-Induced Ototoxicity in Children with Average-Risk Medulloblastoma and Reduced Therapy in Children with Medulloblastoma with Low-Risk Features


Protocol #23-0658, No Longer Enrolling: 1/27/2024
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT05382338

EAY191-E4, ComboMATCH Treatment Trial E4: Nilotinib and Paclitaxel in Patients with Prior Taxane-Treated Solid Tumors (NCT #05554341)


Protocol #23-1959, No Longer Enrolling: 1/13/2024
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05554341

GRADE: The Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study.


Protocol #13-0131, No Longer Enrolling: 6/10/2021
Locations: CTRC-adult, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT01794143

D2D: Vitamin D and Type 2 Diabetes

To assess whether, in participants with pre-diabetes, oral daily vitamin D3 (cholecalciferol) supplementation reduces the rate of progression from prediabetes to diabetes.
Protocol #14-2402, No Longer Enrolling: 11/14/2019
Locations: CTRC-adult, University of Colorado Hospital

Comparison of Weight Loss Induced by Intermittent Fasting Versus Daily Caloric Restriction in Individuals with Obesity: A 1-Year Randomized Trial

This study plans to learn more about the best eating patterns for weight loss. Specifically, this study is being done to try to determine if intermittent fasting is as effective for weight loss as daily calorie restriction. In this study, we will be evaluating how your body weight, body composition, laboratory values, energy expenditure, and eating and exercise behaviors change during a 12-month weight loss program. We will also evaluate how your biology, life experiences, thought processes, behaviors, and environment predict how much weight you lose and how well you follow the diet and exercise recommendations in the study.
Protocol #17-0369, No Longer Enrolling: 6/15/2021
Locations: Anschutz Health and Wellness, UCD Anschutz Health & Wellness Center, University of Colorado Hospital

Tissue-specific effects of insufficient sleep

The proposed project is a within-subject consecutive design examining 14 healthy individuals after baseline and after 4 nights of insufficient sleep. Following 7 days of at-home habitual sleep of 9 hours/night and a 3-day lead-in energy balanced diet, participants will be admitted for a 6-night inpatient stay at the UC Denver. Sleep schedules will be verified via sleep logs, time-stamped voice-recorder of bed and wake times, and wrist actigraphy recordings. On the morning after the 1st night in the lab, subjects will undergo including saliva sampling, endothelial function testing, muscle biopsy, fat biopsy, hyperinsulinemic euglycemic clamp.
Protocol #17-0533, No Longer Enrolling: 12/2/2022
Locations: CTRC Inpatient, CTRC-UC Boulder, University of Colorado Hospital

A Phase III, multi-center, randomized, double-blind, 48 week study with an initial 12 week placebo-controlled period to evaluate the safety and efficacy of osilodrostat in patients with Cushing's disease

This study is a clinical research study consisting of 2 different periods (in the Core phase) with a total expected duration of 48 weeks and the first 12 weeks being a double-blind placebo controlled portion and then 36 weeks of study drug treament, followed by an optional extension phase for an additional 52 weeks (in which case the total duration of study participation will be up to 100 weeks). It is sponsored by the pharmaceutical company named Novartis (the ?Sponsor?). Around 69 patients will join this study in approximately 35 centers located in different countries (around 12) across the world. The purpose of this study is to confirm the effectiveness and safety of osilodrostat in treating patients with Cushing's Disease.
Protocol #17-0483, No Longer Enrolling: 3/10/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02697734

A Phase 3, Randomized, Double--Blind, Placebo--Controlled, Multicenter Study to Evaluate Efficacy and Safety of Octreotide Capsules in Patients Who Previously Tolerated and Demonstrated Biochemical Control on Injectable Somatostatin Receptor Ligands (SRL) Treatment


Protocol #17-0399, No Longer Enrolling: 2/10/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03252353

A Phase 2, Multicenter, Randomized, Single-Blind, Placebo-Controlled Cross-over Study to Assess the Efficacy and Safety of Exendin 9-39 in Patients with Postbariatric Hypoglycemia


Protocol #17-0366, No Longer Enrolling: 7/22/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03373435

A PHASE 2, RANDOMIZED, PLACEBO CONTROLLED STUDY OF SAFETY AND EFFICACY FOLLOWING REPEAT-DOSE ADMINISTRATION OF EVINACUMAB (ANTI ANGPTL3) IN PATIENTS WITH SEVERE HYPERTRIGLYCERIDEMIA (SHTG) AT RISK FOR ACUTE PANCREATITIS (R1500-HTG-1522)


Protocol #17-2118, No Longer Enrolling: 1/6/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03452228

A Double Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of ISIS 766720 (IONIS GHR-LRX, an Antisense Inhibitor of the Growth Hormone Receptor) Administered Once Every 28 Days for 16 Weeks in Patients with Acromegaly Being Treated with Long-acting Somatostatin Receptor


Protocol #18-0756, No Longer Enrolling: 2/10/2021
Locations: University of Colorado Hospital

The Effect of Exercise on Sleep Quality and Nocturnal Fat Oxidation in Individuals with Metabolic Syndrome


Protocol #18-0369, No Longer Enrolling: 5/13/2021
Locations: University of Colorado Hospital

A PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY


Protocol #18-2230, No Longer Enrolling: 10/26/2020
Locations: Childrens Hospital Colorado

Novel Evaluations of Aging and Gender-Affirming Hormone Therapy on Vascular Endothelial Function and Metabolic Profiles in Transgender Women Compared to Age- and BMI-Matched Cisgender Adults


Protocol #18-2258, No Longer Enrolling: 7/19/2023
Locations: Anschutz Health and Wellness, Outpatient CTRC, Outpatient CTRC, Rocky Mountain Regional VA Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04066283

A Phase 2, Interventional, Randomized, Double Blind, Placebo-Controlled Pilot Study of Glucagon RTU in Subjects Who Experience Hyperinsulinemic Hypoglycemia After Bariatric Surgery


Protocol #18-1934, No Longer Enrolling: 10/8/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03770637

A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic Gastroparesis


Protocol #18-2435, No Longer Enrolling: 10/6/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03285308

Long term comparative effectiveness of once weekly semaglutide versus standard of care in a real world adult US population with type 2 diabetes - a randomized pragmatic clinical trial


Protocol #19-0120, No Longer Enrolling: 5/13/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03596450

EnVision CF Multicenter Study of Glucose Tolerance in Cystic Fibrosis

The purpose of this study is to find out what the normal levels of insulin and blood sugar are in children and adults with Cystic Fibrosis. In this study participants will undergo a 3 hour Oral Glucose Tolderance Test, OGTT, and have the option to wear a Continuous Glucose Monitor, CGM, and get a DXA scan.
Protocol #19-0422, No Longer Enrolling: 9/26/2023
Locations: Childrens Hospital Colorado, University of Colorado Hospital

PHASE 1, OPEN-LABEL SAFETY STUDY OF UMBILICAL CORD LINING MESENCHYMAL STEM CELLS (CORLICYTE?) TO HEAL CHRONIC DIABETIC FOOT ULCERS


Protocol #19-1113, No Longer Enrolling: 10/12/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04104451

A Phase 2, Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Adult Subjects with Congenital Adrenal Hyperplasia V: 2Feb2018


Protocol #17-1543, No Longer Enrolling: 8/29/2020
Locations: Childrens Hospital Colorado

A Two-Period, Open-label Trial Evaluating the Efficacy and Safety of Dasiglucagon for the Treatment of Children with Congenital Hyperinsulinism


Protocol #18-2130, No Longer Enrolling: 12/21/2020
Locations: Childrens Hospital Colorado

A double-blind, randomised, placebo-controlled, parallel group trial to evaluate the efficacy and safety of empagliflozin and linagliptin over 26 weeks, with a double-blind active treatment safety extension period up to 52 weeks, in children and adolescents with type 2 diabetes mellitus.


Protocol #18-1223, No Longer Enrolling: 11/2/2022
Locations: Childrens Hospital Colorado

TESTO: Testosterone Effects on Short Term Outcomes in Infants with XXY V:10/5/2017


Protocol #17-1317, No Longer Enrolling: 8/20/2021
Locations: Childrens Hospital Colorado, Department Specific Free Standing Clinic

A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (!Y10 to <18 years) with Type 2 Diabetes Mellitus


Protocol #17-1809, No Longer Enrolling: 5/12/2021
Locations: Childrens Hospital Colorado

A Phase 3, Multicenter, Open-Label, Two-Part Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Leuprolide Acetate 45 mg 6-Month Depot Formulation in Children with Central Precocious Puberty (CPP)


Protocol #18-1716, No Longer Enrolling: 12/7/2020
Locations: Childrens Hospital Colorado

Novel Evaluations of Aging and Gender-Affirming Hormone Therapy on Vascular Endothelial Function and Metabolic Profiles in Transgender Men Compared to Age Group-Matched Transgender Women and Cisgender Adults


Protocol #19-2323, No Longer Enrolling: 7/19/2023
Locations: Anschutz Health and Wellness, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04237467

A Phase 2, Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Pediatric Subjects with Congenital Adrenal Hyperplasia


Protocol #19-1230, No Longer Enrolling: 2/17/2022
Locations: Childrens Hospital Colorado

The effects of hormone therapy on renal hemodynamic function in transgender youth

One screening visit to see if you are eligible to participate, then one study visit prior to starting testosterone or estradiol and one study visit 3 months later.
Protocol #20-0572, No Longer Enrolling: 10/18/2022
Locations: Childrens Hospital Colorado, Outpatient CTRC, Outpatient CTRC
More information available at ClinicalTrials.gov: NCT04482920

Evaluation of Intestinal Permeability and Chronic Inflammation in Patients with Type 2 Diabetes and Obesity Compared to Healthy Lean Controls

Patients will complete two visits- a screening visit and a testing visit. Both visits include blood draws and the testing visit includes blood draws and frequent urine samples. Patients will also be asked to provide a stool sample after screening.
Protocol #20-2179, No Longer Enrolling: 7/26/2023
Locations: CTRC Inpatient, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Adult Subjects with Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment


Protocol #20-2113, No Longer Enrolling: 1/18/2023
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT04490915

Salmon intake and gut health in adults


Protocol #20-1033, No Longer Enrolling: 6/23/2023
Locations: Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital

A Proof-of-Concept Study Examining the Addition of Yoga to a Behavioral Weight Loss Intervention on Energy Balance and Health-Related Outcomes

Participation will include: Blood draws and questionnaires; Assessments of body composition, energy metabolism, and glucose control; Membership to the Anschutz Health and Wellness Center; Monetary compensation
Protocol #21-3690, No Longer Enrolling: 10/23/2021
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05031221

Impact of SomaSignal Tests on the choice of glucose-lowering medications: An Adaptive Implementation Study

This study plans to learn more about using a protein based test called the SomaSignal Cardiovascular (CV) Risk Test in Type 2 Diabetes (CVD-T2D) to improve medical care for patients. The SomaSignal CVD-T2D Test is a specialized blood test that measures the levels of 27 different proteins in your blood and uses the results to help predict your risk of cardiovascular events over the next few years. Providers will be randomized into informed and uninformed groups with their enrolled patients being put into the same group. Patients will be asked to attend 2 research visits along with 2 normally scheduled standard of care visits with their provider. Patients and providers in the informed group will receive CVD-T2D test results before their standard of care visits while those in the uninformed group will not receive results until the end of the study.
Protocol #21-4510, No Longer Enrolling: 7/26/2023
Locations: Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital

Assessing feasibility, safety, and efficacy of deploying a closed-loop automated insulin delivery system by community-based primary care physicians and academic endocrinologists, in person and through telehealth.

The purpose of this study is to learn more about the safety and effectiveness of the iLet - Bionic pancreas device for treating Type 1 diabetes when implemented in primary care and endocrinology, and both in-person and via telehealth. This is a study assessing the feasibility of deploying the iLet bionic pancreas system in the insulin-only configuration to pump-naive MDI users with type 1 diabetes, in the setting of being recruited from community-based primary care practices and being trained and managed by primary care providers, and in pump- and CGM-experienced (sensor-augmented pump or hybrid closed-loop) users with type 1 diabetes recruited from, trained, and managed by an academic endocrinology practice. In both practice settings, the exclusive use of telehealth (TH) visits will be assessed, as will the use of in-person (IP) visits. We will enroll 40 adult volunteers with type 1 diabetes, 20 who are insulin pump naive MDI users enrolled from community primary care practices by University of Colorado Family Medicine and 20 who are technology-savvy sensor-augmented pump or hybrid closed-loop users enrolled by the Massachusetts General Hospital Diabetes Clinical Research Center. Ten of the participants at each center will be trained and managed throughout the trial using in-person visits and the other ten from each center will be trained and managed throughout the trial exclusively via telehealth visits. This will result in four study cohorts overall (endocrinology in-person, endocrinology telehealth, primary care in-person, primary care telehealth). Subjects in all four groups will each participate, in random order, in one 14-day study arm under their own usual care (UC arm) and one 14-day study arm under the insulin-only configuration of the iLet bionic pancreas (iLet arm).
Protocol #21-3272, No Longer Enrolling: 5/25/2023
Locations: Department Specific Free Standing Clinic, Lone Tree Medical Center, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05168657

A Phase 3 Multi-Center, One-Year, Open-Label study of Setmelanotide in Pediatric Patients Aged 2 to <6 years of age with Rare Genetic Causes of Obesity


Protocol #21-4459, No Longer Enrolling: 6/2/2022
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT04966741

BRIGHT- Randomized, sham-controlled, multicenter, pragmatic, trial with open-label extension of BT-100 to improve glycemic control in adults with type 2 diabetes

Randomized, sham-controlled, multicenter, pragmatic, pivotal trial with open-label extension evaluating the hypothesis that PHOENIX, an investigational digital therapeutic intended to help patients with type 2 diabetes improve their glycemic control, will lower hemoglobin A1c (HbA1c) compared to a sham application added to usual care across a broad range of patients in a real-world setting
Protocol #22-0325, No Longer Enrolling: 5/31/2023
Locations: Harmony Campus, Medical Center of the Rockies

Randomized, sham-controlled, multicenter, pragmatic, trial with open-label extension of PHOENIX to improve glycemic control in adults with type 2 diabetes in a real-world setting

- To evaluate the efficacy and safety of the digital therapeutic, Phoenix, to improve HbA1c at three (3) and six (6) -months compared to a control group. - To evaluate the long-term effectiveness and impact on health care utilization and medication use between study groups in real-world clinical practice over a pragmatic extension period of an additional 18 months.
Protocol #22-0315, No Longer Enrolling: 3/7/2023
Locations: Memorial Hospital Central
More information available at ClinicalTrials.gov: NCT05266625

A Phase IIa, randomized, double-blind placebo-controlled, dose comparison, multi-centre adaptive design clinical trial to evaluate the immune signature of the treatment with the Imotope IMCY-0098 and its effect on the preservation of beta-cell function in adult patients with a recent onset Type 1 diabetes

Subcutaneous injections of IMCY-0098 or placebo every 2 weeks, for a total of 7 injections
Protocol #22-0478, No Longer Enrolling: 4/18/2023
Locations: Barbara Davis Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04524949

A Randomized, Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects with Non-pharmacologically Treated Acromegaly

The purpose of this study is to see if the Sponsor’s investigational (research) medication called paltusotine is tolerable, safe, and effective in controlling the growth hormone (GH) levels of patients with acromegaly. GH acts on many parts of the body to promote growth in children. Once the growth in childhood is over, GH does not further increase height. In adults, it does not normally cause growth, but it helps to maintain normal body structure and function, including helping to keep blood sugar within set levels. However, the benign pituitary tumor that causes acromegaly makes too much GH and it affects the body by promoting abnormal growth of the bones of the hands, feet, face, jaw, and soft tissues. These high GH levels can lead to a wide range of cardiovascular (heart and blood vessels issues, e.g., high blood pressure), respiratory (lungs), endocrine (hormone) and metabolic (e.g., diabetes; elevated blood sugar) illnesses, as well as joint pain, weakness, and sometimes visual disturbances. Patients with acromegaly have too much IGF-1 in the blood caused by too much GH. Paltusotine is the study medication being tested. It is a somatostatin agonist which may help to lower the GH in the body. It is a tablet that will be taken by mouth (orally). Paltusotine is an “investigational” medication. This means the United States Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulatory authorities have not approved paltusotine for treating acromegaly or any other disease. Your regular doctor cannot prescribe paltusotine. Paltusotine is only available as part of this study. The purpose of this study is to see if the Sponsor s investigational (research) medication called paltusotine is tolerable, safe, and effective in controlling the growth hormone (GH) levels of patients with acromegaly.
Protocol #22-1406, No Longer Enrolling: 4/6/2023
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05192382

Investigator- and subject-blinded, randomized, placebo-controlled study to evaluate safety, tolerability, pharmacokinetics and efficacy of CFZ533 in pediatric and young adults with new onset type 1 diabetes mellitus (T1DM)

1st treatment of study drug or placebo given by IV infusion Weekly subcutaneous injections of study drug or placebo for 1 year (52 weeks) Completion of a study diary to record insulin dose, and hypoglycemic events CGM measurements 8 mixed-meal tolerance tests (MMTTs): a test where the participant drinks high protein drink without giving insulin coverage. Blood samples are then collected from an IV over time to monitor glucose levels and the participant’s natural ability to still produce insulin.
Protocol #22-0191, No Longer Enrolling: 4/1/2023
Locations: Barbara Davis Center, Childrens Hospital Colorado, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04129528

A Multicenter, Phase 2, Randomized, Open-label, Active-controlled, Parallel Group Clinical Trial to Investigate the Safety, Tolerability, and Efficacy of Different Dose Levels of Once-weekly Lonapegsomatropin Compared to Daily Somatropin in Prepubertal Individuals with Turner Syndrome


Protocol #22-1731, No Longer Enrolling: 9/14/2023
Locations: Childrens Hospital Colorado

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study with an Open-Label Extension Assessing the Efficacy, Safety, and Pharmacokinetics/Pharmacodynamics of Tirzepatide in Pediatric and Adolescent Participants with Type 2 Diabetes Mellitus Inadequately Controlled with Metformin, or Basal Insulin, or Both (SURPASS-PEDS)


Protocol #22-0513, No Longer Enrolling: 1/4/2024
Locations: Childrens Hospital Colorado

A Phase 3, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Setmelanotide in Patients with Acquired Hypothalamic Obesity


Protocol #23-0221, No Longer Enrolling: 10/27/2023
Locations: Childrens Hospital Colorado

The Colonic Microbiome and Mucosal Immunity in Inflammatory Bowel Disease and Ankylosing Spondylitis

This study uses colonic biopsies to compare immune cell function and gut microbiome between those with IBD, AS, AS/IBD overlap, and healthy controls. To evaluate the relationship between the colonic microbiome and the immune system in AS, IBD, AS+IBD, and healthy controls.
Protocol #14-1507, No Longer Enrolling: 7/6/2021
Locations: Colorado Research Center, Denver Health and Hospital Authority, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02389075

A Randomized, Open-label, Phase 2 Study to Evaluate Safety and Efficacy of DUR-928 in Subjects with Primary Sclerosing Cholangitis (PSC)

DUR-928 (investigational drug)
Protocol #18-0123, No Longer Enrolling: 1/6/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03394781

An Open-Label, Multicenter and Open Enrollment Model, Postmarketing, Milk-Only Lactation Study to Assess Concentration of Vedolizumab in Breast Milk of Lactating Women With Active Ulcerative Colitis or Crohn's Disease Who Are Receiving Vedolizumab Therapeutically

The safety of medications to treat UC and CD during pregnancy and lactation is of significant interest of childbearing potential, as these medications may be transferred in utero or though breast milk form nursing mothers to their newborns. It is unknown whether vedolizumab is present in human breast milk.
Protocol #16-0066, No Longer Enrolling: 6/9/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02559713

A Multicenter, Single-Arm Study of Endoscopic Ultrasound-Guided Drainage of Walled-off Pancreatic Necrosis with Lumen-Apposing Metal Stents

The purpose of this study is to determine if a newer type of metal stent with a plastic covering, called the AXIOSTM stent, is safe and effective in draining your WON.
Protocol #18-0442, No Longer Enrolling: 12/3/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03525808

An Observational Cohort Study of the Use of Avatrombopag in Patients with Thrombocytopenia Associated with Chronic Liver Disease Undergoing a Procedure


Protocol #18-1144, No Longer Enrolling: 1/6/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03554759

A Multicenter, Double-Blind, Parallel-Arm, Placebo-Controlled Phase 2 Study of the Efficacy, Safety, and Tolerability of Oral Full-Spectrum Microbiota? (CP101) in Subjects with Recurrence of Clostridium difficile Infection (2/22/2018 version 3)

This is a double-blind, placebo-controlled, parallel-arm, multicenter study comparing the safety, tolerability, and efficacy of CP101 treatment relative to placebo in adults with previously treated recurrent CDI. Subjects who are experiencing recurrent CDI will undergo screening procedures. Subjects who meet eligibility criteria will be randomized to study drug. Approximately 200 subjects (100 subjects per treatment group) will be randomized in a 1:1 ratio to receive CP101 (6  1011 bacteria) or placebo. The treatment duration will be 1 day, including active drug (CP101) and placebo. Subjects will be monitored for recurrence of CDI, safety, and tolerability for 24 weeks following Randomization. The primary efficacy and safety endpoints will be evaluated at 8 weeks post-treatment, and all subjects will continue to be followed for an additional 16 weeks for safety and recurrence of CDI. To qualify for the study, subjects must be experiencing recurrent CDI defined as: a)  3 episodes of CDI, with 2 episodes occurring within the previous 12 months (inclusive of the current episode); OR b) 2 episodes of CDI occurring within the previous 6 months (inclusive of the current episode) AND 65 years of age or older. Additionally, to qualify, recurrent CDI subjects must have received standard-of-care CDI antibiotics for the most recent CDI episode (for 10-21 days, with exact duration, antibiotic type, and dose at the discretion of the Investigator) and have an adequate clinical response, defined as  3 unformed stools in 24 hours for 2 or more consecutive days immediately prior to Randomization.
Protocol #18-1166, No Longer Enrolling: 9/28/2021
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03497806

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial of Oral IW-3718 Administered to Patients with Gastroesophageal Reflux Disease while receiving Proton Pump Inhibitors

The Treatment Period begins with treatment assignment and lasts for 8 weeks. Patients will be stratified by whether they have, or do not have, erosive esophagitis on the screening EGD, and by their baseline heartburn severity level (average heartburn severity score over the last 7 days prior to randomization of <3 vs. ≥3; see Criteria for Evaluation, below) and randomly assigned within each stratum to placebo or 1500 mg IW-3718 BID (1:1). The treatment randomization schedule will be managed by a central vendor. Enrollment will be monitored to ensure that no single center contributes > 10% of the targeted study enrollment, unless otherwise approved by the Medical Monitor. Study drug will be taken immediately after the morning and evening meals. Patients will continue to take their PPI approximately 30-60 minutes before breakfast each day and to use the eDiary to provide their daily assessments (GERD symptoms and assessment of sleep), weekly assessments (degree of relief of GERD symptoms, symptom bothersomeness, and treatment satisfaction questions). At the end of the treatment period study medication will be discontinued and patients will return for an End-of-Treatment (EOT) Visit. All patients who have erosive esophagitis (LA classification A-D) on EGD at Screening and completed ≥4 weeks of treatment will have a repeat EGD at their EOT Visit. Patients will also complete all End-of-Treatment assessments
Protocol #18-2021, No Longer Enrolling: 6/10/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03327727

A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Olaparib Alone or in Combination With Bevacizumab Compared to Bevacizumab With a Fluoropyrimidine in Participants with Unresectable or Metastatic Colorectal Cancer who Have not Progressed Following First-line Induction (LYNK-003)


Protocol #19-6102, No Longer Enrolling: 8/23/2022
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital
More information available at ClinicalTrials.gov: NCT04456699

EA2187: "A Phase 2 Study of Pevonedistat in Combination with Carboplatin and Paclitaxel in Advanced Intrahepatic Cholangiocarcinoma"


Protocol #20-0584, No Longer Enrolling: 4/2/2021
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital
More information available at ClinicalTrials.gov: NCT04175912

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AK002 in Patients with Moderately to Severely Active Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis Who Have an Inadequate Response with, Lost Response to, or Were Intolerant to Standard Therapies

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of AK002 in patients with EG and/or EoD who have an inadequate response with, lost response to, or were intolerant to standard therapies. Patients enrolled in the study will receive 6 infusions of placebo or AK002 administered every 4 weeks and will be followed for 812 weeks after the last dose unless patients elect to enter the optional long-term extension study. Patients will be consented and then screened for 3–5 weeks (2118–35 days) prior to Day 1. Patients who meet all eligibility criteria can be enrolled into the study. Patients, who do not meet all eligibility criteria at screening or who qualify at screening but are not enrolled, may be assigned a new patient identification number and rescreened once. Patients rescreened within 30 days of signing the initial consent will not need to sign a new informed consent form (ICF) providing no changes have been made to the ICF. The primary objective of the study is to evaluate the efficacy and safety of AK002 in patients with moderately to severely active EG and or/ED, with inadequate or loss of response to, or intolerance to standard therapies, when compared with placebo,
Protocol #19-3096, No Longer Enrolling: 8/19/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04322604

A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Sclerosing Cholangitis (VISTAS)

Volixibat is an experimental treatment, meaning that it has not yet been approved by the US Food and Drug Administration or any worldwide regulatory body. Volixibat is a medicine that lowers circulating bile acid levels that are believed to lead to the itching in patients with PSC. There are no other medicines approved to treat itching in patients with PSC. This is the first time volixibat will be used in patients with PSC. In the first part of this study, called the “Core Study,” the study medicine will be compared with a placebo for a period of 28 weeks. A placebo is a capsule that looks exactly like the study medicine but does not contain any active ingredient. At any time during this part of study, you may be given volixibat or placebo. Whether you receive volixibat or placebo will be decided randomly (by chance, like flipping a coin/rolling a die). In the Core Study, between 50% and 67% of participants will receive volixibat. To make this study fair, for part of the study, you and the study doctor will not be told which medicine or placebo you will receive. This is called “blinding.” In case of an emergency, the study doctor will be able to look up the medicine or placebo you are taking/receiving at any time. In the next part of this study, called the “Open-Label Extension,” all eligible participants who choose to continue will receive volixibat for up to 2 years. The primary and secondary objectives and endpoints will be evaluated in participants with PSC who have a baseline score of ≥4 on the Adult Itch-Reported Outcome (ItchRO), as assessed during the single-blind, placebo run-in period during the core study.
Protocol #20-2820, No Longer Enrolling: 11/1/2021
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04663308

A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

This is an international, multicenter evaluation of seladelpar in a randomized, double-blind, placebo-controlled, parallel-group study in patients with PBC. Approximately 180 subjects will be randomized in 2:1 ratio (seladelpar:placebo) across approximately 150 sites worldwide. Enrolled subjects will have confirmed PBC as defined by having any 2 of the following 3 diagnostic criteria: (1) history of ALP above 1.0? the upper limit of normal (ULN) for at least 6 months; (2) positive antimitochondrial antibody (AMA) titer (>1:40 on immunofluorescence or M2 positive by enzyme lin1;4ed immunosorbent assay [ELISA]) or positive PBC-specific antinuclear antibodies (ANAs); and (3) documented liver biopsy results consistent with PBC. Enrolled subjects must have received UDCA for at least 12 months (>3 months of stable dose prior to screening) or have intolerance to UDCA (last dose of UDCA >3 months prior to screening). During the study, the study drug will be administered as an add-on to UDCA therapy for subjects who tolerate UDCA; for subjects with UDCA intolerance, the study drug will be administered as a monotherapy. Subjects with the presence or history of cirrhosis with complications, Gilbert’s syndrome with elevated total bilirubin, primary sclerosing cholangitis (PSC), current features of autoimmune hepatitis (AIH), biopsy-confirmed nonalcoholic steatohepatitis (NASH), alcoholic liver disease, or chronic hepatitis B or C will be excluded. In order to establish the histological status of their liver before and after treatment, all subjects will be encouraged to have a liver biopsy during the Screening Period and after 1 year of treatment, or at Early Termination if the subjects withdraw from the study, provided that they have received at least 6 months of treatment. A follow-up liver biopsy will be performed only in subjects with baseline liver biopsy. Transient elastography via FibroScan? will be performed to assess liver stiffness at baseline and during the Treatment Period or at Early Termination. On Day 1, subjects will be randomized into 1 of 2 treatment arms (seladelpar 10 mg or placebo) in a 2:1 ratio. Subjects will be stratified at randomization according to ALP <350 U/L versus ≥350 U/L and pruritus numerical rating scale (NRS) (<4 versus ≥4) to ensure even distribution across the treatment groups. The total duration of participation in the study for each subject will be up to 14 months and consists of Screening Period (up to 2 weeks), a Run-in Period (up to 2 weeks), a Treatment Period with a maximum duration of up to 12 months, and a Safety Followup Period (1 month after the last dose, only for subjects who are not enrolled in the long-term study). The Screening Period will be up to 2 weeks, during which time subject eligibility will be confirmed. The Run-in Period will start 2 weeks prior to the planned Day 1 Visit; at this visit, subjects start their pruritus evaluation using an e-diary. Liver biopsy will be performed at any time between Screening and Day 1 for subjects willing to undergo the procedure and after their eligibility is confirmed. At Day 1, subjects will enter the Treatment Period. Subjects will receive double-blinded treatment for 12 months. After the completion of the Treatment Period, subjects will be invited to enroll into an open-label, long-term study (Study CB8025-31731-RE) in which each subject will be administered seladelpar and subjects on placebo will initiate seladelpar treatment. Subjects who decline long-term study participation will have a follow-up visit performed 1 month after the last dose of study drug. The primary objective of this study is to evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on ALP and total bilirubin and to evaluate the safety of seladelpar over 12 months of treatment compared to placebo
Protocol #21-2480, No Longer Enrolling: 9/27/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04620733

Radiologic and Mechanistic Assessment of Sarcopenia in Children with Chronic Liver Disease

This study plans to learn more about muscle wasting in children with chronic liver disease. We know that older people with chronic liver disease can have severe loss of muscle and that this increases their risk of poor outcomes associated with their liver disease. We hope to find out more information about if muscle wasting is happening in children with liver disease and what may be driving the loss of muscle mass.
Protocol #21-3275, No Longer Enrolling: 3/2/2022
Locations: Childrens Hospital Colorado

Fibrinolysis Resistance in Pediatric Liver Transplant Surgery: A Potential Therapeutic Target to Reduce Post-Operative Hepatic Artery Thrombosis

We hope to figure out the following aims: Aim 1: Describe the timing and duration of fibrinolysis resistance in pediatric liver transplant recipients pre-operatively through post-operative day 5 with tEG and t-PA TEG, and contrast coagulation profiles to adult liver transplant recipients during a similar time course. Aim 2: Determine if fibrinolysis shutdown on post-operative day 1 is associated with hepatic artery thrombosis. Aim 3: Characterize a targeted coagulation proteome of pediatric liver transplant recipients that remain in fibrinolysis shutdown on post-operative day 1 versus liver recipients that recover to normal fibrinolysis function.
Protocol #18-1295, No Longer Enrolling: 3/2/2022
Locations: Childrens Hospital Colorado

A Prospective, Multicenter Study to Compare and Validate Endoscopic, Histologic, Molecular, and Patient-Reported Outcomes in Pediatric and Adult Patients With Eosinophilic Esophagitis (EoE), Gastritis (EG) and Colitis (EC)

Specific Aim 1- Determine the correlation of EoE, EG, EGE and EC clinical outcome measures (COMs) with mucosal eosinophilia. Primary Objective-To perform a prospective, multicenter, pediatric and adult longitudinal study to determine the correlation of COMs (PROs, QoL and endoscopy) with the established biomarker of peak mucosal eosinophil count (Phase 1). Specific Aim 2- Determine the correlation of the molecular profile for EoE, EG, EGE and EC with clinical outcome measures (COMs) and mucosal eosinophilia. Primary Objective-To perform a prospective, multicenter, pediatric and adult exploratory study to compare the transcriptomes (EoE transcriptome, EG-transcriptome , EGE-transcriptome and EC transcriptome) with their respective peak mucosal eosinophil counts and respective COMs generated in Aim 1. Specific Aim 1 Secondary Objective-To determine how the EoE, EG, EGE and EC COMs and tissue histology change over time in order to determine a better understanding of the natural history of the disease and response to therapy. (Phase 2) Specific Aim 2 Secondary Objective- To perform an exploratory study to compare the four transcriptomes to each other in order to identify patterns of similarity and differences in order to understand the etiological relationship of these diseases and potential therapeutic strategies moving forward.
Protocol #15-1913, No Longer Enrolling: 3/2/2022
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02523118

A Multicenter, Open-Label PK Study of Mirikizumab in Pediatric Patients with Moderately to Severely Active Ulcerative Colitis SHINE-1


Protocol #19-2668, No Longer Enrolling: 3/2/2022
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT04004611

Post Approval Study: Longitudinal Monitoring of Newly Implanted Subjects with the Nucleus Hybrid L24 Cochlear Implant System

The visit dates for this study are a candidacy evaluation, a baseline evaluation, the Initial Activation, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years. Most of these visits will be at the same time as your clinical audiologist visits. To evaluate the long term safety and effectiveness of the Nucleus Hybrid L24 Implant in a group of newly implanted individuals
Protocol #14-1927, No Longer Enrolling: 9/29/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02379819

A PROSPECTIVE, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, MULTICENTER, PHASE 3 EFFICACY AND SAFETY STUDY OF OTO-104 GIVEN AS A SINGLE INTRATYMPANIC INJECTION IN SUBJECTS WITH UNILATERAL MENIERE'S DISEASE

Participants will come into the clinic for 5 visits which will last 1.5-3.5 hours long. Each visit has an Audiologist and an Otologist component in it. Each participant will need to complete daily diary entries by calling into phone number and answering some questions.
Protocol #18-1269, No Longer Enrolling: 3/2/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03664674

Laryngeal Chemosensation: A Pilot Study


Protocol #18-1057, No Longer Enrolling: 12/3/2019
Locations: University of Colorado Hospital

A 24-Week Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study Evaluating the Efficacy and Safety of Intranasal Administration of 186 and 372 ?g of OPN-375 Twice a Day (BID) in Subjects with Chronic Sinusitis With or Without the Presence of Nasal Polyps

OptiNose intends to study the efficacy and safety of OPN-375 in subjects with chronic sinusitis.
Protocol #18-2823, No Longer Enrolling: 9/17/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03781804

Evaluation of AutoSense OS on a Naida CI M90 Sound Processor Programmed with Target CI Fitting Software in Adult Users of the HiResolution Bionic Ear System


Protocol #19-2598, No Longer Enrolling: 7/23/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04237207

Colorado Oral Strengthening Device

A new study is looking at a device that would strengthen the muscles of the mouth to make eating and drinking easier for those who have trouble swallowing. Participants will be randomized to either the group using the investigational device for tongue exercise or the group using standard of care tongue depressors. All participants will receive compensation for participating. To develop a low-cost device that improves patient outcomes by eliciting the same methods of action of existing higher cost devices. To assess if exercising the tongue with this novel device can achieve increased tongue strength among individuals with Parkinson's disease.
Protocol #19-1850, No Longer Enrolling: 11/18/2020
Locations: University of Colorado Hospital

Development and Content Validation of Instruments to Screen for and Assess Severity of Tinnitus in Young People


Protocol #19-2940, No Longer Enrolling: 4/28/2021
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT00000000

The contributions of age related changes in the sound localization pathway to central hearing loss

This study plans to learn more about how age affects the way we process sounds we hear. If you join the study, you will come into our Auditory Lab on the Anschutz Medical Campus 4-6 times and complete hearing assessments and questionnaires. To learn more about how age affects the way we process sounds we hear.
Protocol #19-1213, No Longer Enrolling: 8/24/2022
Locations: Department Specific Free Standing Clinic
More information available at ClinicalTrials.gov: NCT04513782

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 2 STUDY OF OTO-313 GIVEN AS A SINGLE INTRATYMPANIC INJECTION IN SUBJECTS WITH UNILATERAL SUBJECTIVE TINNITUS

If you are to take part in this study, you would be able to come to the clinic for 6 visits which lasts about 110 days. Visit 1 (Screening) and 2 (Baseline) will have about the same procedures done: 1. We will ask about your demographics, medical history, and current medications and check you vital signs 2. We will ask you some questionnaires 3. We will do a blood draw and take your urine for lab tests to check the safety of the medication 4. The Provider will examine your ears and an Audiologist will check your hearing 5. You will receive an electronic Daily Diary which you will need to complete every night of the trial 6. During Visit 2, if you qualify, you will be randomized in to the placebo or the investigational product group. This is a completely blind trial. The Providers, Audiologists, Clinical Research Staff and yourself won't know which group you are in. You will receive the injection. For Visits 3 – 5: 1. We will ask you about your current medications, changes to your health, and take your vital signs 2. We will ask you some questionnaires 3. The Provider will examine your ears and an Audiologist will check your hearing For Visit 6: 1. We will ask you about your current medications, changes to your health, and take your vital signs 2. We will ask you some questionnaires 3. We will do a blood draw and take your urine for lab tests to check the safety of the medication 4. The Provider will examine your ears and an Audiologist will check your hearing
Protocol #21-3418, No Longer Enrolling: 2/4/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04829214

Critical Windows in the Development of Asthma Endotypes and Phenotypes in High-Risk Toddlers

We are studying how asthma develops in early childhood to help doctors provide better asthma treatments for children. If you decide to participate, your child will complete up to five research visits. There will be one visit per year over 4 years. During the visits your child will do breathing tests, and we will swab their nose using one or two swabs. We will give you a nighttime breathing monitor to measure your child's breathing for two nights while they are sleeping. We may take a blood sample at the first and last visits. You will also be sent a secure link to a survey about your child's health. This study plans to learn more about how asthma develops in early childhood. This will help doctors understand how to provide better asthma treatments to improve children s health.
Protocol #21-3116, No Longer Enrolling: 1/9/2024
Locations: Childrens Hospital Colorado

A randomised, double-blind, parallel group Phase III study to assess the efficacy and safety of 100 mg SC depemokimab in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) - ANCHOR-1 (depemokimAb iN CHrOnic Rhinosinusitis)

If you choose to participate, you will have 17 visits for a little over 1 year. Most visits will be about 4 weeks apart; some will be 2 weeks apart. Visits are typically about 2 hours long, but the first visit, two injection visits, and the second to last visit will take about 6 hours. There are also some visits where we can do a telehealth visit with you, so you won't need to come to clinic. We will be asking you some questions, providing you a mobile device for you to complete questions once a day, conducing physical exams and vital signs, having doctors look inside your nose (nasal endoscopy), going for a CT Scan at the beginning and end of the study, looking at the electrical activity of your heart (Electrocardiogram (ECG)), asking you about your health and your medications, doing blood and urine tests, if you are able to become pregnant we will check to see if you are pregnant, and providing the study drug or a placebo. The placebo contains no active medicine. Like the study drug, it will be given as one injection under the skin every 6 months. Clinical trials often include a placebo so that effects seen in people who receive a study drug can be compared to effects seen in people who do not receive a study drug.
Protocol #22-1480, No Longer Enrolling: 7/29/2023
Locations: Anschutz Health and Wellness, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05274750

An Observational, Multicenter Study of the Prevalence of Cerebrotendinous Xanthomatosis (CTX) in Patient Populations Diagnosed with Early-Onset Idiopathic Bilateral Cataracts


Protocol #16-0145, No Longer Enrolling: 2/10/2021
Locations: Childrens Hospital Colorado

A RANDOMIZED, PARALLEL-ARM, ACTIVE CONTROL, MULTICENTER STUDY ASSESSING THE SAFETY AND EFFICACY OF DEXTENZA? FOR THE TREATMENT OF OCULAR PAIN AND INFLAMMATION FOLLOWING SURGERY FOR PEDIATRIC ATARACT


Protocol #21-2605, No Longer Enrolling: 11/1/2023
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT04539548

An Open-label, Phase 1/2 Trial of Gene Therapy 4D-125 in Males with X-linked Retinitis Pigmentosa (XLRP) Caused by Mutations in the RPGR Gene

This is a multicenter study with two parallel parts: an observational Natural History Cohort and an open-label, prospective interventional trial in males with non-syndromic XLRP due to mutations in RPGR. The target population is restricted to avoid confounding atypical presentation in female patients. The Natural History Cohort seeks to examine the course of disease and aid in the development of clinical endpoints for male adult and pediatric patients with XLRP who do not seek experimental therapy in this study. The Phase 1/2 trial is designed to assess the safety and tolerability of 4D-125 following IVT administration; preliminary clinical efficacy will also be examined. The study looks to evaluate the following objectives for the two parallel parts: Natural History • Characterize the population of patients with XLRP aged 6 years and older, and evaluate natural progression of disease. Phase 1/2 • Evaluate the safety and tolerability of 4D-125 following IVT administration. • Identify the appropriate dose level of 4D-125 for further evaluation. • Assess the relationship between the dose of 4D-125 and indicators of visual function. • Evaluate clinical activity and impact on health-related quality of life (HRQOL) of 4D-125 in males with XLRP.
Protocol #20-0130, No Longer Enrolling: 2/7/2024
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04517149

Face Masks, Behavioral and Environmental Modifications, and Dry Eye

If you join the study, we will ask you to answer questions about the symptoms of your dry eye. We will measure the humidity around your eyes; this will be done by asking you to wear a pair of non-framed eyeglasses with a small hygrometer attached to the frame in front of your eyes. Hygometer measures the humidity in the air. Neither the eyeglasses nor the hygometer will touch your eyes. We also will take photographs to document your mask fit. We will exam the surface of your eyes, which involves using fluorescein eye drops to stain the outer surface of your eye. You may feel a slight stinging sensation when the dye is first applied. After a few moments, the dye will feel like normal liquid on the eye and will no longer be uncomfortable. The fluorescein eye drops are considered safe. There is no lasting stain, but the eyelids and cheeks may be colored, which can be wiped off by gentle washing.
Protocol #21-2541, No Longer Enrolling: 8/6/2022
Locations: Denver Health and Hospital Authority, University of Colorado Hospital

IMVT-1401-3201: A Phase 3, Multi-center, Randomized, Quadruple-masked, Placebo-controlled Study of Batoclimab for the Treatment of Participants with Active Thyroid Eye Disease (TED)


Protocol #22-1591, No Longer Enrolling: 2/7/2023
Locations: University of Colorado Hospital

A Randomized Trial of Low-Dose Bevacizumab versus Laser for Type 1 Retinopathy of Prematurity (ROP3)


Protocol #21-3951, No Longer Enrolling: 12/16/2023
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT04634604

A Phase 2 Randomized, Multicenter, Double-blind, Vehicle-controlled, 12-Week, Safety, Efficacy, and Systemic Exposure Study followed by a 12-Week Open-label Extension of Trifarotene (CD5789) Cream HE1 in Adults and Adolescents with Autosomal Recessive Ichthyosis with Lamellar Scale


Protocol #19-0396, No Longer Enrolling: 2/10/2022
Locations: Childrens Hospital Colorado

Phase I Study of Feasibility and Safety of UCD19 Chimeric Antigen Receptor (CAR) T Cells in Adult Subjects with Relapsed/Refractory (R/R) B-Cell Non-Hodgkin's Lymphoma (B-NHL)


Protocol #19-2807, No Longer Enrolling: 6/6/2020
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04240808

A Pivotal Phase 3 Study of FCX-007 (Genetically-Modified Autologous Human Dermal Fibroblasts) for Recessive Dystrophic Epidermolysis Bullosa (DEFI-RDEB)


Protocol #19-1972, No Longer Enrolling: 2/24/2023
Locations: Childrens Hospital Colorado

ACcomplisH: A Phase 2, multicenter, double-blind, randomized, placebo-controlled, dose escalation trial evaluating safety, efficacy, and pharmacokinetics of subcutaneous doses of TransCon CNP administered once weekly for 12 months in prepubertal children with achondroplasia


Protocol #20-0142, No Longer Enrolling: 2/25/2023
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT04085523

Cardiovascular consequences of hypogonadism in men


Protocol #15-1162, No Longer Enrolling: 5/24/2023
Locations: Outpatient CTRC, Rocky Mountain Regional VA Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02758431

Effect of Mechanical Circulatory Support on Exercise Capacity in Heart Failure


Protocol #16-1635, No Longer Enrolling: 8/5/2023
Locations: Colorado Research Center, CTRC-adult, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03078972

The impact of estrogen status on the biological function of brown adipose tissue in women measured using quantitative PET/CT

The physiological relevance of brown adipose tissue in humans is largely unknown. We have shown that suppressing ovarian function in premenopausal women reduces resting energy expenditure (REE), and this is prevented by adding back estradiol (E2). Our preliminary data suggest that this may be due, in part, to reduced brown adipose tissue (BAT) activity. However, whether E2 status affects BAT activity in women has not been studied. In this research, we will study 1) the contribution of BAT to REE under basal (room temperature) and stimulated conditions (mild cold-exposure); and 2) whether these responses are modulated by E2 status.
Protocol #16-1479, No Longer Enrolling: 2/2/2024
Locations: CTRC-adult, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02927392

The effect of isotretinoin on the etonogestrel contraceptive implant


Protocol #16-0614, No Longer Enrolling: 8/18/2021
Locations: Comprehensive Women's Health Center, Comprehensive Womens Health Center

Reprometabolic Syndrome Mediates Subfertility in Obesity


Protocol #15-1052, No Longer Enrolling: 2/4/2022
Locations: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02653092

Dysregulation of FSH in Obesity: Functional and Statistical Analysis

This study plans to learn more about the relationship between fertility and obesity.
Protocol #15-0474, No Longer Enrolling: 3/2/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02478775

The Cellular Pharmacology of F-TAF in dried blood spots

The goal of this study is to vary the amount of F-TAF dosing and see if the drug levels in dried blood spots (DBS) change in a predictable way.
Protocol #16-0972, No Longer Enrolling: 10/16/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02962739

Myeloid to Adipocyte Transdifferentiation in Human cells

If you join the study, you will complete the following research procedures over the course of 2 study visits: Informed consent, physical exam and medical history, body composition test, blood draw and fat biopsy. This research study plans to learn more about where the fat cells in your body come from. Understanding the origin of fat cells is important because it may help to determine the health of fat cells and why fat that is stored in some places of your body is more "unhealthy" than other fat.
Protocol #15-1779, No Longer Enrolling: 6/16/2021
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02654925

Appetite Regulation in Older-Aged Obese Individuals

Participants needed for a research study that plans to examine the effects of age and body weight on food intake, appetite regulation, and brain responses to food.
Protocol #15-1511, No Longer Enrolling: 1/26/2022
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02721303

Validation of a method for isotopic analysis in human plasma samples V:04/20/2018


Protocol #16-2739, No Longer Enrolling: 4/30/2021
Locations: University of Colorado Hospital

Effects of Ovarian Hormone Suppression on Vascular and Cognitive Function


Protocol #17-0092, No Longer Enrolling: 6/17/2021
Locations: University of Colorado Hospital

Rapid measurements of water isotopes in human breath and saliva for doubly labeled water analysis V: 04/03/18


Protocol #16-2203, No Longer Enrolling: 10/12/2023
Locations: Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03233256

Mitochondrial targeted antioxidant supplementation and diastolic function in healthy men and women

As we get older, our cardiovascular health worsens. This can lead to high blood pressure and heart disease. In this study we want to find out what causes cardiovascular health to worsen in older men and women. Also we want to find out what happens to the cardiovascular system when we take a dietary antioxidant supplement for a short period of time. Specifically, we want to see if the antioxidant supplement will improve cardiovascular health in older men and women because of damage to mitochondria. Mitochondria are the main power supply of the cells in our body. The results from this study will help to understand whether improvements in mitochondrial function will also improve cardiovascular health in older men and women.
Protocol #17-1782, No Longer Enrolling: 12/2/2022
Locations: Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital

Precision Approach to PPI Therapy in Gastroesophageal reflux disease

Over the past 25 years, RALS has been increasingly, and often incorrectly, diagnosed and has emerged as a point of controversy and confusion. Despite the limitations of current diagnostic tests and therapeutic strategies, recent advances in gastoresophageal reflux disease offer tremendous potential for RALS diagnosis and treatment. Newer diagnostic tools are able to assess physiologic properties of RALS. Thus, this study will address three crucial gaps impacting the clinical approach to RALS: 1) Paucity of diagnostic tests that predict clinically relevant outcomes, 2) undefined clinical role of UES augmentation, and 3) deficiency or cost-effective and personalized approaches.
Protocol #18-0205, No Longer Enrolling: 5/3/2022
Locations: University of Colorado Hospital

Mechanisms for Sleep/Circadian Disruption-Induced Impairments in Bone Formation

We are looking for healthy men to participate in a research study on the effects of sleep restriction on bone. The purpose of this research is to understand how shortened sleep affects bone metabolism. The study includes an intervention phase consisting of a 1-week outpatient and 8-night inpatient stay. Participants will be observed after discharge from the intervention phase for 3 weeks. Principal Investigator, Christine Swanson, MD, MCR (COMIRB #18-0015)
Protocol #18-0015, No Longer Enrolling: 10/8/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03733483

Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis (StopRA)


Protocol #15-1868, No Longer Enrolling: 9/21/2022
Locations: Barbara Davis Center, UCD Barbara Davis Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02603146

CU Faces of Hope-Genetics of Craniofacial and Dental Development Research Study

This study plans to collect samples to create a database of patients with various syndromes that affect the way bones of the face are formed, termed “craniofacial”. These samples will support a new research program, named CU Faces of Hope, which involves a team of researchers and doctors who will work together toward a goal of better understanding facial development and gain knowledge about your specific syndrome. Samples, such as blood, DNA, and cells, will be stored for future approved research. The reason for collecting both health information and blood/tooth samples from the same person is to look at relationships between physical symptoms, behavior, genes, and parts of the blood. We are also asking parents and siblings of people with these various craniofacial associated syndromes to join the study. Having information available from family members can help researchers look at differences between people who have a syndrome and those who do not.
Protocol #18-1916, No Longer Enrolling: 4/21/2023
Locations: Childrens Hospital Colorado

Effect of freestyle skiing on bone mineral density


Protocol #19-0802, No Longer Enrolling: 2/21/2020
Locations: Barbara Davis Center, UCD Barbara Davis Center

Cardiopulmonary and Right Ventricular Function in Health and Disease

The primary objective of this research protocol is to advance the understanding of cardiopulmonary and right ventricular (RV) performance among individuals with cardiomyopathy (heart failure with reduced ejection fraction [HFrEF], heart failure with preserved ejection fraction [HFpEF]), as well as athletes engaging in endurance/prolonged exercise, who are at a high risk of an acquired cardiomyopathy during/following completion of an endurance event. Examine the heart function of elite athletes and heart failure patients utilizing a novel catheter system.
Protocol #19-1141, No Longer Enrolling: 7/6/2023
Locations: Brain Imaging Center - BIC, CTRC Inpatient, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04147299

Neurophysiological Correlates V: 31Jan18


Protocol #16-1480, No Longer Enrolling: 3/7/2023
Locations: Childrens Hospital Colorado

Validation of the Apollo EE Device, Indirect Calorimetry


Protocol #20-0317, No Longer Enrolling: 8/3/2023
Locations: Anschutz Health and Wellness, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital

Colorado Nurses Experience with COVID-19

The purpose of the study is to find out the experiences of nurses who cared or prepared to care for COVID-19 patients. If you join the study you will help us learn about what nurses are going through during this pandemic time. You will provide insight to how nurses can improve or change the delivery of care to patients during a pandemic.
Protocol #20-6039, No Longer Enrolling: 3/2/2023
Locations: Boulder Health Center, Broomfield Hospital, Cherry Creek Medical Center, Grandview Hospital, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Longs Peak Hospital, Longs Peak Hospital, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Pikes Peak Regional Hospital, Poudre Valley Hospital, UCHealth Central Park Medical Center, UCHealth Internal Medical Clinic - Lowry, UCHealth Inverness, UCHealth Steadman Hawkins Clinic - Denver (Inverness), University of Colorado Hospital, Yampa Valley Medical Center

A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older (mRNA-1273-P301)


Protocol #20-1619, No Longer Enrolling: 4/25/2023
Locations: Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04470427

Use of accelerometers to improve estimation of the thermic effect of feeding in whole room calorimetry studies

What you receive for participating: -Personalized information about your energy expenditure ("metabolism") -Five total days of food -Monetary compensation Test whether accelerometer-based measures of physical activity from Actigraph and ActivPAL accelerometers can be used to improve the calculation of TEF in whole room calorimeter studies.
Protocol #20-0191, No Longer Enrolling: 9/3/2021
Locations: University of Colorado Hospital

The HPV 9-10 Trial: Early Initiation of HPV Vaccination


Protocol #19-3006, No Longer Enrolling: 2/4/2021
Locations: CHOC ? Children?s Hospital of Orange County, UCLA - University of California, UCLA, Jonsson Cancer Center, University of Colorado Hospital

Sex effects on the neurobiology of eating behaviors in Veterans with overweight/obesity

Participants will complete: - 2 to 4 MRI scans - Food, attention, and mood questionnaires - Blood draws for measuring hormones Participants will be compensated for their time
Protocol #19-0940, No Longer Enrolling: 8/12/2022
Locations: Outpatient CTRC, Outpatient CTRC, Rocky Mountain Regional VA Medical Center, University of Colorado Hospital

Premature Vascular Aging in Women following an In Vitro Fertilization Pregnancy

Ultrasound of blood vessels, blood draw, 24-hour blood pressure monitoring, body composition and bone mineral density testing Compensation is provided. The purpose of this research study is to evaluate if women who have had a pregnancy conceived through IVF exhibit increased blood pressure compared with women who did not have an IVF pregnancy one-to-five years earlier. To answer this, we will recruit: 1) Women with a prior IVF pregnancy 1-5 years earlier; 2) Women with a healthy pregnancy conceived through spontaneous (unassisted) conception 1-5 years earlier. Main inclusion/exclusion: 1) Age 18-45 years 2) Non-smoking 3) Not currently taking medications to treat high blood pressure or cholesterol 4) Not currently pregnant or wishing to become pregnant in the next 3 months
Protocol #21-2903, No Longer Enrolling: 1/24/2024
Locations: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

Opioid modulation and neural reward activation in healthy adults


Protocol #21-2886, No Longer Enrolling: 4/20/2022
Locations: Brain Imaging Center (BIC), Outpatient CTRC, University of Colorado Hospital

Ovarian Hormone Regulation of Central and Cerebrovascular Hemodynamics

Inclusion criteria: - Women aged 18-55 years - Non-smoking - Not taking medications to treat high blood pressure or cholesterol Did you know women represent 2/3rds of the >5 million individuals living with Alzheimer’s disease? We’d like to know why. Changes in vascular function during menopause may contribute to the increased Alzheimer’s disease risk in women. We are inviting premenopausal (women with regular menstrual periods) and postmenopausal (no menstrual period >12 months) women to participate in a study looking at the effects of estrogen and menopause on vascular function in the brain.
Protocol #21-3590, No Longer Enrolling: 2/21/2024
Locations: Outpatient CTRC, University of Colorado Hospital

Investigating the Role of the Endocannabinoid System in Joint Pain

If you join the study, you will be asked to complete one 10-minute study visit at the Barbara Davis Center on the University of Colorado's Anschutz Medical Campus. During this visit, the study coordinator will first go through the consent process and confirm your eligibility, which may require a review of your medical records. Then we will draw a small sample of your blood (4mL or about one teaspoon) that we will use to analyze your body's natural endocannabinoid levels. Your participation in the study will conclude after this blood draw and we will send you a $15 Amazon gift card to thank you for participating.
Protocol #21-3357, No Longer Enrolling: 8/5/2022
Locations: University of Colorado Hospital

Comparing WatchPAT to Polysomnography in the Assessment of Sleep Disordered Breathing in At-Risk Adolescents

Participants will wear the WatchPAT device during their PSG appointment and the results between the two tests will be compared.
Protocol #22-0847, No Longer Enrolling: 6/10/2023
Locations: Childrens Hospital Colorado

Measurement of Hematopoietic Stem Cell Derived Adipocytes

The purpose of this study is to learn more about where the fat tissue in your body originates. For many years it has been thought that all fat cells come from cells that are from the fat tissue itself, but now we know it is possible that some fat cells may originally come from the bone marrow. Understanding the origin of fat cells is important because it may help to determine the health of fat cells. You are being asked to be in this research study because you are a person over the age of 18 who has had a hematopoietic stem cell transplant or has chronic phase chronic myeloid leukemia (CML). To understand if some fat cells (adipocytes) may originally come from cells in the bone marrow. Understanding the origin of fat cells is important because it may help to determine the health of fat cells and why fat that is stored in some places of your body is more unhealthy than other fat.
Protocol #13-0026, No Longer Enrolling: 8/19/2021
Locations: University of Colorado Hospital

Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure-Connect-HF


Protocol #17-0423, No Longer Enrolling: 1/6/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03035474

Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure

Assess your medical care Help researchers better understand your medical treatment and health outcomes Provide an understanding on how diseases impact your daily life Provide you with more information about heart disease
Protocol #17-6148, No Longer Enrolling: 6/27/2020
Locations: Memorial Hospital Central

Randomized Observation of Biventricular pacemakers on ventrIcular function among patients with mechaNical circulatory support devices: "ROBIN"


Protocol #17-1042, No Longer Enrolling: 7/6/2021
Locations: CTRC Inpatient, University of Colorado Hospital

A clinical trial of an Electronic health record-leveraged, Patient-centered, Intensification of Chronic care for Heart Failure (EPIC-HF) patient engagement video and medication options checklist


Protocol #17-1249, No Longer Enrolling: 5/20/2022
Locations: Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital

A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction


Protocol #17-1343, No Longer Enrolling: 1/15/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02929329

Real-time Electrogram Analysis for Drivers of Atrial Fibrillation


Protocol #17-1506, No Longer Enrolling: 11/14/2019
Locations: University of Colorado Hospital

Observational Registry of Treatment Patterns in U.S. Heart Failure Patients with Reduced Ejection Fraction

The objective of this study is to understand real-world treatment patterns, as well as the reasons and barriers for treatment changes in heart failure patients with reduced ejection fraction.
Protocol #16-6062, No Longer Enrolling: 5/20/2020
Locations: Memorial Hospital Central

A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients who have Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement

The purpose of this trial is to establish the safety and efficacy of the Edwards SAPIEN 3 THV device in patients with severe, calcific, aortic stenosis who are at low operative risk for SAVR.
Protocol #16-6069, No Longer Enrolling: 10/1/2019
Locations: Harmony Campus, Medical Center of the Rockies
More information available at ClinicalTrials.gov: NCT02675114

MOMENTUM 3 Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy with HeartMate 3?


Protocol #16-2506, No Longer Enrolling: 10/9/2021
Locations: University of Colorado Hospital

EARLY-TAVR Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients with AsYmptomatic Severe Aortic Stenosis


Protocol #17-6134, No Longer Enrolling: 1/22/2022
Locations: Greeley Campus, Harmony Campus, Long's Peak Hospital, Longs Peak Hospital, Medical Center of the Rockies, Yampa Valley Medical Center
More information available at ClinicalTrials.gov: NCT03042104

Watchman for patients with atrial fibrillation undergoing transcatheter aortic valve replacement

WATCH-TAVR is a prospective, multicenter, randomized event-driven controlled trial.
Protocol #18-6002, No Longer Enrolling: 11/7/2020
Locations: Harmony Campus, Medical Center of the Rockies
More information available at ClinicalTrials.gov: NCT03173534

Multiple cArdiac seNsors for mAnaGEment of Heart Failure (MANAGE-HF)

The MANAGE-HF study is a multi-center, global, prospective, open label, multi-phase trial. Phase I will be non-randomized. Phase II will be randomized. 1) To evaluate and optimize HeartLogic? Heart Failure Diagnostics (called HeartLogic from here on) clinical integration and the alert management process (Phase I) 2. To evaluate HeartLogic in regards to patient outcomes of death and heart failure hospitalizations (Phase II)
Protocol #18-6028, No Longer Enrolling: 5/20/2020
Locations: Memorial Hospital Central, Memorial Hospital North
More information available at ClinicalTrials.gov: NCT03237858

Assessment of the Watchman Device in Patients Unsuitable for Oral Anticoagulation

This study is a prospective, randomized, multi-center, global investigation to determine the safety and effectiveness of the WATCHMAN Device for subjects with non-valvular atrial fibrillation who are deemed not suitable for anticoagulation therapy to reduce the risk of stroke.
Protocol #18-6501, No Longer Enrolling: 1/21/2020
Locations: Memorial Hospital Central
More information available at ClinicalTrials.gov: NCT02928497

An Open-Label Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Subjects with Thrombocytopenia Scheduled for a Surgical Procedure

The purpose of this study is to test the safety and effectiveness of the study drug, avatrombopag, in subjects with thrombocytopenia undergoing an operation. Patients will receive either 60mg or 80mg of avatrombopag once daily by mouth for 5 days prior to surgery
Protocol #18-0546, No Longer Enrolling: 9/15/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03326843

Education Efficacy in Patient Interventions


Protocol #18-6020, No Longer Enrolling: 1/22/2022
Locations: Medical Center of the Rockies

A Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of Once Weekly Subcutaneous Injections of a Sustained-Release VIP Analogue, PB1046, in Adult Subjects with Symptomatic Pulmonary Arterial Hypertension

Once the subject meets entry criteria, the study will enroll into a 25 week study. The subject will have subcutaneous injections once weekly and be expected to return to clinic every 6 weeks. The other weekly visits can be done in the subject's location of choice (i.e. home/work). There are multiple blood draws required for this study at certain time points. Other procedures that the subject will complete during the study are: a complete physical exam, EKGs, laboratory assessments, 6 minute walks, 2 right heart caths - one at the beginning and one at the end of the study and daily blood pressures. The subject will be given a home B/P monitor to use. During this study, the subject has a 66% chance of getting active study drug and a 33% change of getting a placebo. Once the subject completes the study, the subject will have the option to enroll into the open label study during which he/she will be given the active study drug.
Protocol #18-0915, No Longer Enrolling: 10/1/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03556020

A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of CSL112 in Subjects with Acute Coronary Syndrome

If you agree to join the study, screening tests will be performed while you are in the hospital to assess your eligibility for the study. If you are eligible to take part in the study, you will be randomized to receive either the study drug or placebo. ?Randomized? means that you will be assigned by chance, like flipping a coin, to take the study drug (CSL112) or the placebo. You will have a 50/50 chance of receiving either CSL112 or placebo. Both the study drug and placebo will be given by intravenous (IV) infusion which means slowly pumping the drug into your body through a small tube that is inserted into a vein. The infusion will last approximately 2 hours. You will receive up to four (4) infusions of either the study drug or placebo weekly for 4 weeks; each infusion is to be given at least 5 days apart. All 4 infusions should be administered within 30 days of you receiving your first infusion. Additional study visits will occur throughout the next year to assess for any new health problems, side effects, or changes in your medical conditions. This is a double-blind study, which means you, your Study Doctor, and the study staff will not know which treatment you are getting, but your Study Doctor can find out if there is an emergency, if it is critical to know for your health, or after the study has ended and the results have been analyzed. Your participation in the study will be approximately 1 year (365 days). This includes the Screening Period (1 visit), an Active Treatment Period (which includes 4 weekly infusion visits and a follow-up visit for safety) and a Follow-Up Period (which includes 5 visits) to assess any new health problems or side effects you may have experienced since your last study visit and your overall well-being. This study will have 11 study visits, 2 of which may be conducted by telephone during the Follow-Up period.
Protocol #18-6051, No Longer Enrolling: 8/12/2020
Locations: Memorial Hospital Central
More information available at ClinicalTrials.gov: NCT03473223

EMPERIAL-preserved: A phase III randomized, double-blind trial to evaluate the effect of 12 weeks treatment of once daily EMPagliflozin 10 mg compared with placebo on ExeRcise ability and heart failure symptoms, In patients with chronic HeArt FaiLure with preserved Ejection Fraction (HFpEF)

Subjects enrolled in this trial will be randomly assigned to receive either Empagliflozin 10 mg or placebo for 12 weeks.
Protocol #18-0925, No Longer Enrolling: 9/9/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03448406

EMPERIAL-reduced: A phase III randomized, double-blind trial to evaluate the effect of 12 weeks treatment of once daily EMPagliflozin 10 mg compared with placebo on ExeRcise ability and heart failure symptoms, In patients with chronic HeArt FaiLure with reduced Ejection Fraction (HFrEF)

Participants will be randomly assigned to empagliflozin or placebo. Participants will take the study medication (empagliflozin or placebo) for 12 weeks.
Protocol #18-0926, No Longer Enrolling: 9/9/2021
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03448419

A phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy and safety of CSL112 in subjects with acute coronary syndrome.

The primary objective of this study is to evaluate the efficacy of CSL112 on reducing the risk of MACE (CV death, MI, or stroke) from the time of randomization through 90 days in subjects with ACS (diagnosed with STEMI or NSTEMI)
Protocol #18-6081, No Longer Enrolling: 4/13/2021
Locations: Harmony Campus, Medical Center of the Rockies
More information available at ClinicalTrials.gov: NCT03473223

Phase IIb Study of Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells during Stage II Surgical Repair of Hypoplastic Left Heart Syndrome (Auto Cell-II)

Umbilical cord blood is collected at birth and shipped to ReGen Theranostics, Inc for manufacturing. The umbilical cord blood mononuclear cells (MNC) are isolated from the cord blood and frozen. The cells are then transported to the study site when the patient undergoes the Glenn surgery. This study will evaluate the efficacy and safety of UCB-MNC intramyocardial injections performed during Stage II surgical palliation by focusing on short and long-term cardiac function leading up to the pre-op work-up for Stage III surgical palliation.
Protocol #18-2012, No Longer Enrolling: 3/2/2022
Locations: Childrens Hospital Colorado

CLASP IID/IIF

PASCAL System (vs. MitraClip) in treatment of symptomatic degenerative mitral regurgitation
Protocol #18-6126, No Longer Enrolling: 1/22/2022
Locations: Harmony Campus, Medical Center of the Rockies
More information available at ClinicalTrials.gov: NCT03706833

GB001-1101:A Phase 1b, Randomized, Subject- and Investigator-Blinded, Placebo-Controlled, Multi-Center Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Biomarkers of Inhaled GB002 in Subjects with WHO Group 1 Pulmonary Arterial Hypertension (PAH)

This is a multicenter, randomized, blinded and placebo controlled study in subjects with WHO group 1 Pulmonary Arterial Hypertension who will recieve inhaled GB002 or matching placebo for 14 days. The subject will have to visit the clinic for screening and on days 1, 2, 8 and 14. The patient has the option of having a visiting nurse come to them on days 3 to 7 to verify that they are following instrctions for dosing of the study drug and completing their study diary correctly. There will also be a follow up telephone call on days 15 and 42 to assess the patient's physical status and record any additional medications being taken. On day 1 and day 14, the visit will last up to 6 hours and the patient will have 5 blood draws during that time to assess drug levels in the blood and on days 2 and 8, the visi will last up to 2 hours and the patient will have one blood level drawn on these days.
Protocol #18-2672, No Longer Enrolling: 6/16/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03926793

Prospective, multicenter, Single Arm Safety and Effectiveness Confirmatory Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellis System

Patients diagnosed with an abdominal aortic or aortoiliac aneurysm who are considered candidates for endovascular repair and who meet the study eligibility criteria may be screened for enrollment in the study
Protocol #19-6501, No Longer Enrolling: 6/24/2020
Locations: Memorial Hospital Central
More information available at ClinicalTrials.gov: NCT03298477

SELECT: SELExipag in inoperable or persistent/recurrent Chronic Thromboembolic pulmonary hypertension: A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension.

This is a 52 week blinded study in which the subject would recieve either Selexipag or Pacebo. Study visits are approximately every 6 to 12 weeks and study participants may be eligible for the open label extension at the end of 52 weeks.
Protocol #19-0347, No Longer Enrolling: 8/3/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03689244

A PROSPECTIVE, MULTI-CENTER, SINGLE ARM STUDY TO OBTAIN "REAL WORLD" CLINICAL DATA AND CHARACTERIZE THE ACUTE AND LONG-TERM PERFORMANCE OF THE MICRUSFRAME AND GALAXY COILS FOR THE ENDOVASCULAR TREATMENT OF INTRACRANIAL ANEURYSMS

A Prospective, Multi-Center, Single Arm Study to obtain “Real World” Clinical Data and Characterize the Acute and Long-Term Performance of the Micrusframe and Galaxy Coils for the Endovascular Treatment of Intracranial Aneurysms
Protocol #19-6503, No Longer Enrolling: 4/4/2020
Locations: Memorial Hospital Central
More information available at ClinicalTrials.gov: NCT03642639

Edwards Cardioband System ACTIVE Pivotal Clinical Trial

The ACTIVE Trial is a prospective, randomized, multicenter trial. Patients with clinically significant functional mitral regurgitation will be randomized 2:1 to receive either transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT) or GDMT alone.
Protocol #17-2107, No Longer Enrolling: 11/14/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03016975

The CLASP Study - Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study

The Edwards PASCAL System is intended for the percutaneous reconstruction of an insufficient mitral valve in patients with clinically significant, symptomatic mitral regurgitation and:  New York Heart Association (NYHA) Functional Class II, III and ambulatory IV heart failure  The primary regurgitant jet is non-commissural. If a secondary jet exists, it must be considered clinically insignificant
Protocol #18-0876, No Longer Enrolling: 1/6/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03170349

Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR)

This clinical study is a prospective, multicenter, single-arm clinical evaluation of the Multi-Electrode Radiofrequency (RF) Balloon catheter. The purpose of this study is to evaluate the overall safety and effectiveness of the Multi-Electrode RF Balloon catheter, in conjunction with the Multi-Electrode Circular Diagnostic catheter and Multi-Channel RF Generator, for the treatment of drug refractory Paroxysmal Atrial Fibrillation (PAF). Embedded within the Main Study will be a Neurological Assessment Evaluable (NAE) subset and a Cardiac Computed Tomography (CT) or Magnetic Resonance Angiogram (MRA) image (CT/MRA) subset with consecutive enrollment and a prospective design. The same subject can participate in both the NAE and cardiac CT/MRA subsets. The study will enroll subjects with drug refractory, symptomatic PAF who are candidates for catheter ablation. The first 1-3 subjects for each ablating physician will be considered roll-in subjects to verify consistent workflow for study device components and to minimize any learning curve effects. The roll-in subjects will not be included in the NAE subset, cardiac CT/MRA subset, or in the primary endpoint analyses. The roll-in phase will include a maximum of 240 subjects and the main study phase will include a maximum of 400 evaluable subjects. Subjects will be evaluated prior to the procedure, prior to discharge, and post procedure at 7 days (7-14 days), 1 month (23-37 days), 3 months (76- 104 days), 6 months (150-210 days), and 12 months (315-405 days) unless otherwise specified in the protocol.
Protocol #19-1679, No Longer Enrolling: 4/17/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03683030

Comparison of Anticoagulation with Left Atrial Appendage Closure after AF Ablation

This is a study for patients that have a heart condition in which the upper chambers of your heart beat irregularly. This condition, also known as atrial fibrillation, can cause blood clots to form in an area of your heart called the left atrial appendage (LAA). Everyone has a LAA, which is like a pouch on the top of your heart, and it developed along with the other parts of the heart before birth. If a clot forms here, it can increase your chances of having a stroke or other related problems. Because you have atrial fibrillation, it is believed that if the LAA is closed, then blood clots might not be able to form in that area. The current standard of care to prevent stroke in patients with atrial fibrillation is long-term oral anticoagulation (OAC) therapy (blood thinner medication) or, in appropriately selected patients, implant of the commercial WATCHMANTM device followed by short-term OAC therapy.
Protocol #19-6506, No Longer Enrolling: 9/10/2021
Locations: Memorial Hospital Central
More information available at ClinicalTrials.gov: NCT03795298

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Impact of Evolocumab on Major Cardiovascular Events in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke

This is a clinical study sponsored by Amgen Inc. It is a study being done for patients that are at high risk for experiencing a cardiovascular event (like a heart attack or stroke). Elevated cholesterol, in particular low-density lipoprotein cholesterol (LDL-C), can lead to obstructing fatty deposits in blood vessels that can greatly increase the risk of developing cardiovascular disease or experiencing a cardiovascular event. The purpose of this research study is to assess whether lowering of cholesterol blood level can reduce your risk for major cardiovascular events (for example, heart attack or stroke) when evolocumab is taken in addition to current medical therapy as directed by a doctor, which may include a medication for the treatment of abnormal cholesterol blood levels called statins.
Protocol #19-6511, No Longer Enrolling: 11/19/2021
Locations: Memorial Hospital Central
More information available at ClinicalTrials.gov: NCT03872401

ECG Belt for CRT Response

Demonstrate benefit of using the ECG Belt Research System on reducing left ventricular end-systolic volume (LVESV) from baseline to 6 months post-implant compared to standard CRT. ECG Belt arm subjects will be compared with the control arm subjects (combined control arms A and B). A core lab blinded to randomization and follow up status will analyze the echo data and measure LVESV. Demonstrate benefit of using the ECG Belt Research System on reducing left ventricular end-systolic volume (LVESV) from baseline to 6 months post-implant compared to standard CRT. ECG Belt arm subjects will be compared with the control arm subjects (combined control arms A and B). A core lab blinded to randomization and follow up status will analyze the echo data and measure LVESV.
Protocol #19-1703, No Longer Enrolling: 9/29/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03504020

A RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, SAFETY AND DESCRIPTIVE EFFICACY STUDY IN PEDIATRIC SUBJECTS REQUIRING ANTICOAGULATION FOR THE TREATMENT OF A VENOUS THROMBOEMBOLIC EVENT


Protocol #15-1434, No Longer Enrolling: 7/7/2022
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02464969

Early Feasibility Study of the Edwards Transcatheter Atrial Shunt System

Adult patients with symptomatic clinically significant heart failure and elevated left atrial pressure despite guideline directed medical therapy (GDMT).
Protocol #18-2765, No Longer Enrolling: 1/20/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03088033

PREcision Event Monitoring of PatienTs with Heart Failure using HeartLogic

You are being asked to participate in this research study because you have been diagnosed with heart failure and you are implanted with a commercially approved Boston Scientific Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy Defibrillator (CRT-D) device. Inside your device are sensors that monitor your heart failure condition. The purpose of this study is to better understand how sensor readings from your device relate to specific clinical events that you may experience during the time you are in the study. This information may be able to detect when your heart failure is getting worse earlier and with more accuracy. This could help your doctor treat your heart failure timely and with the appropriate treatments.
Protocol #19-6516, No Longer Enrolling: 8/8/2020
Locations: Memorial Hospital Central
More information available at ClinicalTrials.gov: NCT03579641

The impact of feminizing gender-affirming hormone therapy on biomarkers of coagulation and thrombosis


Protocol #20-0104, No Longer Enrolling: 6/19/2021
Locations: University of Colorado Hospital

Evaluation of the VISITAG SURPOINT Module with External Processing Unit (EPU) when used with the THERMOCOOL SMARTTOUCH SF and the THERMOCOOL SMARTTOUCH Catheters for Pulmonary Vein Isolation (PVI)

The SURPOINT COA study is a prospective, multicenter, non-randomized post-market clinical evaluation of the VISITAG SURPOINT™ Module with EPU when used with the STSF/ST catheters in treating subjects with symptomatic PAF who have failed at least one antiarrhythmic drug. A total of 330 subjects will be enrolled at up to 45 sites. Two hundred eighty (280) enrolled subjects will be treated using the STSF catheter with EPU and fifty (50) subjects will be treated with ST catheter. Prior to enrollment, a few sites will be selected to only enroll subjects who will be treated with the ST catheter and the remaining sites will only enroll subjects who will be treated with the STSF catheter. Effectiveness and safety endpoints have been defined, and will be compared to predetermined performance goals. Subjects who sign the SURPOINT COA informed consent are considered enrolled in the study. Enrolled subjects who satisfy all eligibility criteria will then undergo the ablation procedure with the catheter and VISITAG SURPOINT™ Module. After the study ablation procedure, subjects will enter a 3-Month blanking period (Day 0-90). After the Blanking Period, subjects will enter the Evaluation Period (Days 91-365). Subjects having AF recurrence and/or receiving therapeutic interventions during the evaluation period will be considered effectiveness failures (refer to Section 4.1.1 for all effectiveness failure modes). All subjects will undergo follow up visits at defined intervals (refer to Table 5-1 Schedule of Treatments and Evaluations). Subjects complete the SURPOINT COA study after the 12-month follow up visit.
Protocol #19-0003, No Longer Enrolling: 9/29/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03624881

An Open-Label, Single Arm, Multicenter Study to Broaden Access to Emapalumab, an Anti-Interferon Gamma (Anti-IFNy) Monoclonal Antibody, and to Assess its Efficacy, Safety, Impact on Quality of Life, and Long-term Outcome in Pediatric Patients with Primary Hemophagocytic Lymphohistiocytosis


Protocol #19-0105, No Longer Enrolling: 6/9/2021
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03312751

Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR)

Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation To demonstrate the safety based on the incidence of early-onset (within 7 days of ablation procedure) primary adverse events. To demonstrate the 12-month effectiveness based on the proportion of subjects with freedom from documented asymptomatic and symptomatic Atrial Fibrillation, Atrial Tachycardia, or Atrial Flutter episodes
Protocol #19-6101, No Longer Enrolling: 6/14/2022
Locations: Harmony Campus, Medical Center of the Rockies
More information available at ClinicalTrials.gov: NCT03683030

A Phase 3 Global, Double-Blind, Randomized, Placebo‑Controlled Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Transthyretin‑Mediated Amyloid Cardiomyopathy (ATTR CM)

Randomized, double-blind, placebo-controlled study of ION‑682884 vs. placebo administered by SC injection once every 4 weeks for 120 weeks in patients with ATTR-CM receiving available background SoC. Patients will be stratified at Randomization based on NYHA Classification (I and II vs. III), ATTR mutation status (mutated vs. wild-type), 6MWT (≤ 350 meters vs. > 350 meters), and current treatment with tafamidis (Yes vs. No). Study Drug (ION‑682884 or placebo) will be administered for 120 weeks (Treatment Period) followed by an additional 20 weeks of Post-Treatment Evaluation Period.
Protocol #19-2854, No Longer Enrolling: 10/29/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04136171

A Randomized, Controlled Phase 3 Study of Pacritinib Versus Physician s Choice in Patients with Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post Essential Thrombocythemia Myelofibrosis with Severe Thrombocytopenia (Platelet Counts <50,000/μL)


Protocol #19-2788, No Longer Enrolling: 7/24/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03165734

The Cardiovascular Multi-dimensional Observational Investigation of the Use of PCSK9 Inhibitors (cvMOBIUS)

While you are taking part in in the study, you will see your doctor as usual. Your doctor will make notes (medical records) about your disease and its treatment as he/she normally would. For the next 5 years, a study coordinator at your doctor’s office will collect information from your doctor’s notes about your medical condition and treatments, including any medication changes.
Protocol #19-6518, No Longer Enrolling: 12/22/2020
Locations: Memorial Hospital Central, Memorial Hospital North
More information available at ClinicalTrials.gov: NCT04197453

OPTION

This study is a prospective, randomized, multi-center, global investigation to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation in patients after AF ablation.
Protocol #20-6502, No Longer Enrolling: 7/17/2021
Locations: Medical Center of the Rockies
More information available at ClinicalTrials.gov: NCT03795298

An open-label, repeat-application, intra-subject, dose escalation (Part 1) followed by a randomized, double-blind, placebo-controlled (Part 2) trial of topical VT30 in subjects with venous, lymphatic or mixed malformations associated with PIK3CA or TEK genetic mutations


Protocol #20-1757, No Longer Enrolling: 5/7/2022
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT04409145

STOP BLOQ: (Surveillance and Treatment to Prevent Fetal Atrioventricular Block Likely to Occur Quickly)


Protocol #20-1310, No Longer Enrolling: 9/30/2021
Locations: Childrens Hospital Colorado, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04474223

The ENCIRCLE high-risk trial: SAPIEN M3 system TransCatheter mitral valve ReplaCement vis TransseptaL AccEss

To establish the safety and effectiveness of the SAPIEN M3 System in subjects with mitral regurgitation (MR) who are at high surgical riskv
Protocol #20-2889, No Longer Enrolling: 4/22/2022
Locations: Medical Center of the Rockies
More information available at ClinicalTrials.gov: NCT04153292

Pathophysiology of Vaccine-Induced Thrombotic Thrombocytopenia

To determine the mechanisms behind vaccine induced thrombotic thrombocytopenia
Protocol #21-3401, No Longer Enrolling: 4/2/2022
Locations: Department Specific Free Standing Clinic

A Phase 1/2 Study to Evaluate the Safety and Efficacy of a Single Dose of Autologous Clustered Regularly Interspaced Short Palindromic Repeats Gene-edited CD34+ Human Hematopoietic Stem and Progenitor Cells (EDIT-301) in Subjects with Severe Sickle Cell Disease


Protocol #20-2626, No Longer Enrolling: 9/22/2023
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT04853576

A Phase 3, Open-label, Single Arm, Multicenter Study of Ravulizumab in Addition to Best Supportive Care in Pediatric Participants (from 1 month to < 18 years of age) with Thrombotic Microangiopathy (TMA) after Hematopoietic Stem Cell Transplantation (HSCT)


Protocol #20-2471, No Longer Enrolling: 1/13/2023
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT04557735

AALL1821 - A Phase 2 Study of Blinatumomab (NSC# 765986, IND# 125462) in Combination with Nivolumab (NSC # 748726, IND# 125462), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged Greater than or equal to 1 to < 31 Years Old with First Relapse


Protocol #21-3049, No Longer Enrolling: 1/27/2024
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT04546399

Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial, with Cross-Over, of Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of posoleucel (ALVR105) as compared to placebo for the treatment of AdV infection in pediatric and adult recipients of HCT with AdV infections receiving SoC. Approximately 80 participants at approximately 40 clinical sites in the US and Europe will be enrolled into the study and randomized 1:1 to receive posoleucel or placebo. Randomization will be stratified by level of viremia and age. To compare the percent of participants who have clearance of AdV viremia at Day 29 in participants receiving posoleucel and SoC to that in participants receiving placebo and SoC.
Protocol #22-0182, No Longer Enrolling: 1/12/2024
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT05179057

Scleroderma Lung Study III (SLS III): Combining the anti-fibrotic effects of pirfenidone (PFD) with mycophenolate (MMF) for treating scleroderma-related interstitial lung disease


Protocol #17-1226, No Longer Enrolling: 4/23/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03221257

A PHASE 2A, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF RSLV-132 IN SUBJECTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS

- assess the impact of 13 IV infusions of RSLV-132 on cutaneous lupus disease activity using the CLASI activity score. -assess improvement in disease activity using SLEDAI-2K, BILAG-2004 and PGA; - evaluate the immunogenicity of RSLV-132 in subjects with SLE; - assess improvement in tender or swollen joint count; - assess improvement in patient reported outcomes using the FACIT-Fatigue scale; - assess the ability of subjects to reduce oral steroids at Day 169; ? evaluate the safety and tolerability of 22 weeks of RSLV-132 exposure; - assess the proportion of subjects achieving a 50% improvement in CLASI activity score - assess the following exploratory endpoints -- evaluate the impact of RSLV-132 treatment on gene expression profile; -- evaluate the impact of RSLV-132 treatment on autoantibody and complement profiles; -- evaluate the impact of RSLV-132 on serum protein levels; -- assess the impact of RSLV-132 on the CLASI damage score
Protocol #16-0603, No Longer Enrolling: 1/4/2020
Locations: Barbara Davis Center, UCD Barbara Davis Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02660944

A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects with Systemic Lupus Erythematosus (SLE)

-To evaluate the efficacy and dose response of evobrutinib (also referred to as M2951) compared to placebo in reducing disease activity in adult subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard of care (SoC) therapy based on SLE Responder Index (SRI)-4 response at Week 52 in all subjects, or on SRI-6 response at Week 52 in the High Disease Activity (HDA) subgroup, defined as SLE Disease Activity Index 2000 (SLEDAI-2K) !Y 10 -To evaluate the safety of M2951 in subjects with SLE on SoC therapy
Protocol #17-0405, No Longer Enrolling: 1/6/2021
Locations: Barbara Davis Center, UCD Barbara Davis Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02975336

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis


Protocol #17-1792, No Longer Enrolling: 10/1/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03398837

A randomized, controlled pilot trial to evaluate the efficacy and safety of subcutaneous Abatacept in treating interstitial lung disease associated with the anti-synthetase syndrome


Protocol #17-2000, No Longer Enrolling: 1/6/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03215927

A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS


Protocol #18-0489, No Longer Enrolling: 1/4/2020
Locations: Barbara Davis Center, UCD Barbara Davis Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03161483

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus


Protocol #18-0907, No Longer Enrolling: 1/4/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03517722

A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE)


Protocol #18-2346, No Longer Enrolling: 9/10/2021
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03742037

A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TAK-079 in Combination With Standard Background Therapy in Patients With Moderate to Severe Systemic Lupus Erythematosus


Protocol #19-0027, No Longer Enrolling: 9/29/2021
Locations: Barbara Davis Center
More information available at ClinicalTrials.gov: NCT03724916

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy and Safety Study of Methotrexate to Increase Response Rates in Patients with Uncontrolled Gout Receiving Krystexxa (pegloticase)(MIRROR Randomized Controlled Trial [RCT])


Protocol #19-1717, No Longer Enrolling: 4/11/2020
Locations: Barbara Davis Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03994731

A Phase 3, Randomized, Double-blind, Placebo and Adalimumab-controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects with Active Psoriatic Arthritis Who Are Naive to Biologic DMARD Therapy


Protocol #19-2533, No Longer Enrolling: 5/13/2021
Locations: Barbara Davis Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04115748

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects with Active Psoriatic Arthritis Who Have an Inadequate Response or are Intolerant to Biologic DMARD Therapy


Protocol #19-2534, No Longer Enrolling: 5/13/2021
Locations: Barbara Davis Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04115839

Determination of Hypoallergenicity of an Extensively Hydrolyzed Infant Formula in Infants and Children with Cow's Milk Allergy

This is a multi-center, randomized, double-blind, placebo-controlled food challenge (DBPCFC) to be conducted in infants or children with confirmed IgE-mediated cow’s milk allergy (CMA), followed by a 7-day open feeding of the experimental formula
Protocol #21-2701, No Longer Enrolling: 3/9/2022
Locations: Childrens Hospital Colorado

A Phase 4, Multicenter, Open-label, Efficacy and Safety Trial of Pegloticase and Methotrexate Co-administered in Patients with Uncontrolled Gout who have Previously Received Pegloticase Monotherapy but did not Maintain a Serum Uric Acid Response


Protocol #21-3601, No Longer Enrolling: 9/26/2023
Locations: Barbara Davis Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04772313

A Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment with Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults with Early, Seropositive Rheumatoid Arthritis Who Have "Shared Epitope" HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate


Protocol #21-3663, No Longer Enrolling: 11/3/2023
Locations: Barbara Davis Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04909801

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Guselkumab in Subjects with Active Lupus Nephritis


Protocol #20-1490, No Longer Enrolling: 10/11/2022
Locations: Barbara Davis Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04376827

A Phase 4, Multicenter, Open-Label, Infusion Duration Study To Assess Safety, Tolerability and Efficacy of Pegloticase Administered With a Shorter Infusion Duration in Subjects with Uncontrolled Gout Receiving Methotrexate

Approximately 80-100 participants will be enrolled. After a 4-week methotrexate run-in period, participants will be treated for up to 24 weeks with weekly oral methotrexate and biweekly 8mg pegloticase infusions. Up to three pegloticase infusion durations will be assessed in the study: 60-minute infusion, 45-minute infusion and 30-minute infusion. Safety evaluations will be performed regularly throughout the course of the study. To assess tolerability of Pegloticase administered with shorter infusion duration in subjects with uncontrolled gout receiving methotrexate.
Protocol #22-1077, No Longer Enrolling: 11/3/2023
Locations: Barbara Davis Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04511702

Growth study using a Toddler almond based nutritional drink (test) vs. a. formula that has been shown to support growth (control) in Healthy Toddlers

To investigate the effect of the almond based nutritional drink (AND) on weight gain in toddlers as compared to a standard toddler formula (Enfagrow) based on cow’s milk protein. We hypothesize that mean weight gain between AND and Enfagrow groups will be similar. Both AND and Enfagrow may be referred to as formula for the remainder of this document.
Protocol #21-4644, No Longer Enrolling: 6/30/2023
Locations: Childrens Hospital Colorado

A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS

This phase III, double-blind study will have two arms: Experimental-Participants will receive obinutuzumab 1000 mg IV infusions on Day 1 and at Weeks 2, 24 and 26; Placebo Comparator-Placebo participants will receive obinutuzumab matched placebo on Day 1 and at Weeks 2, 24 and 26. The trial will last for 52 weeks. Adults aged 18 years to 75 years are eligible. This parallel-group, double-blind, placebo-controlled study will evaluate the efficacy and safety of obinutuzumab versus placebo in participants with active, autoantibody-positive systemic lupus erythematosus (SLE) who are treated with standard-of-care therapy.
Protocol #21-3268, No Longer Enrolling: 1/12/2024
Locations: Barbara Davis Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04963296

A Phase 1b/2, randomized, double-blind, placebo-controlled, multi-center study of STMC-103H in neonates and infants at high-risk for developing allergic disease


Protocol #20-2925, No Longer Enrolling: 1/5/2024
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT05003804

NIH RECOVER: A Multi-site Observational Study of Post-Acute Sequelae of SARS-CoV-2 Infection in Adults (Pregnancy Arm)

This study is looking at the long-term implications of COVID-19 infection in pregnant patients. Study participants may be asked to answer sets of questions about ongoing symptoms, give samples such as blood and urine and possibly have some other imaging tests. Have you been pregnant since January 2020 and NEVER have had COVID? If so, we need your help! Join a study to help us learn how having COVID when pregnant affects the long-term health of the pregnant person and their baby. We'll compare people who had COVID when pregnant to those who didn't – this helps us learn what’s related to having Long COVID and how it affects their babies.
Protocol #22-2323, No Longer Enrolling: 1/6/2024
Locations: Outpatient CTRC, University of Colorado Hospital

GS-US-380-4030: Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching from a Regimen of Dolutegravir and Either Emtricitabine/Tenofovir Alafenamide or Emtricitabine/Tenofovir Disoproxil Fumarate to a Fixed Dose Combination of Bictegravir/ Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Subjects who are Virologically Suppressed


Protocol #17-0713, No Longer Enrolling: 11/14/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03110380

A5320:Viral Hepatitis C Infection Long-term Cohort Study (V-HICS)


Protocol #13-3028, No Longer Enrolling: 10/22/2019
Locations: University of Colorado Hospital

A PHASE 3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF A CLOSTRIDIUM DIFFICILE VACCINE IN ADULTS 50 YEARS OF AGE AND OLDER


Protocol #16-2637, No Longer Enrolling: 5/4/2022
Locations: CTRC-adult, University of Colorado Hospital

The relationship between the gut microbiome composition and pulmonary immune function in HIV infection


Protocol #17-1512, No Longer Enrolling: 3/8/2022
Locations: University of Colorado Hospital

Mitochondria in HIV and Aging (MITO+)

The general hypothesis of the proposed pilot study is that older, HIV-infected individuals with a prolonged antiretroviral therapy (ART) treatment history experience an even greater burden of mitochondrial dysfunction, and resulting symptoms of muscle fatigue, physical function impairment, and impaired exercise tolerance compared to HIV-uninfected controls of a similar age and body mass index (BMI).
Protocol #17-2161, No Longer Enrolling: 7/6/2021
Locations: University of Colorado Hospital

A5366: Selective Estrogen Receptor Modulators to Enhance the Efficacy of Viral Reactivation with Histone Deacetylase Inhibitors


Protocol #17-2431, No Longer Enrolling: 4/6/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03382834

Implementing a pharmacist-led protocol to survey and follow-up people living with HIV taking Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) single tablet regimen after being switched from two tablet regimen of Dolutegravir plus Emtricitabine/Tenofovir Alafenamide (DTG + FTC/TAF): patients' satisfaction and adherence


Protocol #18-0715, No Longer Enrolling: 8/24/2023
Locations: University of Colorado Hospital

An Open-label Study to Assess the Intrapulmonary Concentrations of Cefiderocol at Steady State in Hospitalized Subjects with Bacterial Pneumonia on Treatment with Standard of Care Antibiotics and Requiring Mechanical Ventilation

The study is being performed in patients with bacterial pneumonia, an infection in the lung[s] to determine how safe the experimental drug, cefiderocol, is and the amount of cefiderocol that is in blood and lung secretion over time (also known as pharmacokinetics or PK). All participants in this study will receive the study drug.
Protocol #18-1706, No Longer Enrolling: 10/13/2020
Locations: University of Colorado Hospital

A5357: A Study of Long-Acting Cabotegravir Plus VRC01LS to Maintain Viral Suppression in Adults Living with HIV-1


Protocol #18-2315, No Longer Enrolling: 10/18/2023
Locations: Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03739996

A5370: Safety and Immunotherapeutic Activity of an Anti-PD-1 Antibody (Cemiplimab) in HIV-1-infected Participants on Suppressive cART: A Phase I/II, Double-blind, Placebo-controlled, Ascending Multiple Dose Study

Scientists are looking for ways to effectively clear HIV-1 that stays in the body despite successful antiretroviral treatment. Anti-PD-1 is a type of antibody that may target certain cells called latently infected cells where HIV hides and may improve the body's ability to clear these cells, allowing for the possibility of reducing the amount of HIV that persists (the HIV reservoir). This study will include participants who are diagnosed with HIV-1 and suppressed on their current antiretroviral medications.
Protocol #18-2675, No Longer Enrolling: 11/2/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03787095

A Pilot Study in the Treatment of Refractory Adenovirus (ADV) Infection with Related Donor ADV Cytotoxic T-Lymphocytes (ADV-CTLs)in Children, Adolescents and Young Adult Recipients - NYMC 579


Protocol #19-0858, No Longer Enrolling: 3/27/2021
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03266627

GS-US-200-4334: A Phase 2 Randomized, Open Label, Active Controlled Study Evaluating the Safety and Efficacy of Long-acting Capsid Inhibitor GS-6207 in Combination with Other Antiretroviral Agents in People Living with HIV

This study will test an experimental drug named GS-6207 (long acting capsid inhibitor) in combination with other HIV medications for the treatment of human immunodeficiency virus (HIV) infection. An experimental drug means that it is not yet approved for the treatment of HIV-1 Infection by the United States Food and Drug Administration (FDA) and your country’s regulatory agency. Other HIV medications included in this study are B/F/TAF (Biktarvy?) and, F/TAF (Descovy?), which are currently approved by the U.S. FDA for the treatment of HIV infection and TAF (VEMLIDY?) and Bictegravir (BIC) which are part of the medication Biktarvy but are not currently approved as a single agent HIV medication by the U.S. FDA. This is a randomized, open label study. Open-label means you and your study doctor will know what study drugs you will be taking. Randomized means the study treatment you take will be chosen by chance (like flipping a coin) to receive one of four study treatments. The randomization for this study is in a 2:2:2:1 ratio. You will have 6 out of 7 chances to receive GS-6207 in combination with other HIV medications and a 1 out of 7 chance to receive B/F/TAF.
Protocol #19-2810, No Longer Enrolling: 9/26/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04143594

A5380: A Phase II Trial of Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection (PURGE-C)


Protocol #20-0303, No Longer Enrolling: 10/18/2023
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04042740

A5379: B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B

A5379 is a study looking at hepatitis B vaccination in adults living with HIV. Hepatitis B is a serious viral infection that affects the liver and is transmitted through blood and body fluids. The study will involve individuals who have received a previous hepatitis B vaccination but the vaccine did not respond well and individuals who have never received the vaccination. The study will take place both in the US and internationally. The study will compare how well an individual responds to the vaccine in different groups based on the type of vaccine and number of doses.
Protocol #19-2935, No Longer Enrolling: 11/17/2022
Locations: Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04193189

Prone Positioning on Admission for Hospitalized COVID-19 Pneumonia Protocol


Protocol #20-6034, No Longer Enrolling: 4/13/2023
Locations: Medical Center of the Rockies
More information available at ClinicalTrials.gov: NCT04424797

AN ADAPTIVE PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY ASSESSING EFFICACY AND SAFETY OF SARILUMAB FOR HOSPITALIZED PATIENTS WITH COVID-19


Protocol #20-0615, No Longer Enrolling: 9/24/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04315298

A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734 ) in Participants with Severe COVID-19 (GS-US-540-5773)


Protocol #20-0616, No Longer Enrolling: 1/7/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04292899

ODYSSEY: A randomized, double-blind, placebo-controlled study to investigate the efficacy of in treating inflammatory lung injury and improving clinical outcomes associated with severe COVID-19 infection


Protocol #20-6037, No Longer Enrolling: 8/13/2021
Locations: Greeley Campus, Long's Peak Hospital, Medical Center of the Rockies, Poudre Valley Hospital
More information available at ClinicalTrials.gov: NCT04326426

Explorations into the mechanism for INSTI-associated weight gain: a focus on energy balance


Protocol #19-2960, No Longer Enrolling: 2/16/2023
Locations: Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04495348

The Use of Ultrasound in Establishing COVID-19 Infection as Part of a Trauma Evaluation

This study is to learn more about the effectiveness of EFAST evaluation of the chest to trauma patients to identify the effect of the lungs from COVID-19 infections. This study is to evaluate the effectiveness of Expanded Focused Assessment with Sonography in Trauma (EFAST) in identifying high risk trauma patients with active COVID-19 pulmonary infections.
Protocol #20-0751, No Longer Enrolling: 8/3/2022
Locations: Childrens Hospital Colorado, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04340479

IMPAACT 2019: Phase I/II Study of the Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less than 12 Years of Age, Version 1.0


Protocol #18-2714, No Longer Enrolling: 9/20/2022
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03760458

ODYSSEY: A randomized, double-blind, placebo-controlled study to investigate the efficacy of tradipitant in treating inflammatory lung injury and improving clinical outcomes associated with severe COVID-19 infection

The tradipitant therapy is being studied to explore if the administration prevents or treats the cytokine storm and acute respiratory distress syndrome leading to respiratory failure and high mortality in affected patients with COVID-19.
Protocol #20-6506, No Longer Enrolling: 8/12/2021
Locations: Memorial Hospital Central, Memorial Hospital North
More information available at ClinicalTrials.gov: NCT04326426

A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19

To estimate the efficacy, safety, tolerability and reactogenicity of 2 IM doses of AZD1222 compared to placebo for the prevention of COVID-19 in adults. To see if you qualify for the study, please visit this webpage: http://bit.ly/covid19vaccinestudy
Protocol #20-9990, No Longer Enrolling: 2/23/2021
Locations: Greeley Campus, Medical Center of the Rockies, Poudre Valley Hospital
More information available at ClinicalTrials.gov: NCT04516746

A Phase 3 Open-Label Clinical Study to Evaluate the Safety and Tolerability of Rebiotix RBX2660 (microbiota suspension) in Subjects with Recurrent Clostridium difficile Infection


Protocol #19-2746, No Longer Enrolling: 12/2/2021
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03931941

A PHASE 1, OPEN-LABEL DOSE-FINDING STUDY TO EVALUATE SAFETY, TOLERABILITY, AND IMMUNOGENICITY AND PHASE 2/3 PLACEBO-CONTROLLED, OBSERVER-BLINDED SAFETY, TOLERABILITY, AND IMMUNOGENICITY STUDY OF A SARS-COV-2 RNA VACCINE CANDIDATE AGAINST COVID-19 IN HEALTHY CHILDREN ≥5 TO <12 YEARS OF AGE

In this new study, we will learn if the vaccine can produce an immune response against COVID-19, and if it is safe, in children 5-11 years old. All participants will have the opportunity to receive the COVID-19 study vaccine during their time in the trial.
Protocol #21-2841, No Longer Enrolling: 8/18/2021
Locations: Childrens Hospital Colorado

Engaging practices and communities in the development of interventions to promote HPV vaccine uptake


Protocol #18-0338, No Longer Enrolling: 1/12/2024
Locations: Department Specific Free Standing Clinic
More information available at ClinicalTrials.gov: NCT04279964

Doravirine for Persons with Excessive Weight Gain on Integrase Inhibitors and Tenofovir Alafenamide (The Do IT Study)


Protocol #21-3534, No Longer Enrolling: 12/20/2023
Locations: Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04636437

Randomized, Controlled Trial to Evaluate the Anti-inflammatory Efficacy of Letermovir (Prevymis) in Adults with Human Immunodeficiency Virus (HIV)-1 and Asymptomatic Cytomegalovirus (CMV) Who Are on Suppressive ART and Its Effect on Chronic Inflammation, HIV Persistence, and Other Clinical Outcomes (ELICIT)


Protocol #21-4059, No Longer Enrolling: 10/18/2023
Locations: Outpatient CTRC, Outpatient CTRC
More information available at ClinicalTrials.gov: NCT04840199

Phase II, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of a Modified Vaccinia Ankara (MVA)-based anti-Cytomegalovirus (CMV) Vaccine (Triplex?), in Adults with Both Human Immunodeficiency Virus (HIV)-1 and CMV Who Are on Potent Combination ART with Conserved Immune Function


Protocol #21-4360, No Longer Enrolling: 12/20/2023
Locations: Outpatient CTRC, Outpatient CTRC
More information available at ClinicalTrials.gov: NCT05099965

A Multi-site Observational Study: NIH RECOVER Study of Long COVID in Adults

This is a longitudinal study enrolling individuals with and without SARS-CoV-2 infection at varying stages before and after infection and with or without post-acute sequelae of SARS-CoV-2 (PASC). The aim is to better understand risk factors and occurrence of PASC. Study data including age, demographics, social determinants of health, medical history, vaccination history, details of acute SARS-CoV-2 infection, overall health and physical function, and PASC symptom screen will be reported by subjects or collected from the electronic health record using a case report form at specified intervals. Biologic specimens will be collected at specified intervals. Characterize the incidence and prevalence of sequelae of SARS-CoV-2 infection. Characterize the spectrum of clinical symptoms, subclinical organ dysfunction, natural history, and distinct phenotypes identified as sequelae of SARS-CoV-2 infection. Define the biological mechanisms underlying pathogenesis of the sequelae of SARS-CoV-2 infection.
Protocol #21-4528, No Longer Enrolling: 10/31/2023
Locations: Cherry Creek Medical Center, Highlands Ranch Hospital, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05172024

A Phase 3, Double-Blind, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous Twice Yearly Long-Acting Lenacapavir for HIV Pre Exposure Prophylaxis in Cisgender Men, Transgender Women, Transgender Men, and Gender Non-binary People ≥ 16 Years of Age who Have Sex with Male Partners and are at Risk for HIV Infection (GS-US-528-9023)


Protocol #21-3252, No Longer Enrolling: 12/20/2023
Locations: Outpatient CTRC, Outpatient CTRC

A Phase 3, multicenter, randomized, double-blind, 48-week study of the clinical and antiviral effect of S-217622 compared with placebo in non-hospitalized high-risk participants with COVID-19

Participation in the study will last about 24 weeks and participants will have at least 8 study visits. Participants will be randomly assigned to take the investigational drug or a placebo as 3 tablets on the first day of study treatment followed by 1 tablet a day for 4 days. The SCORPIO-HR Study is a clinical research study looking at an investigational drug for COVID-19 in people who have tested positive and whether it can help resolve COVID-19 symptoms faster and reduce COVID-19 symptoms that persist for several months (called “long COVID”).
Protocol #22-0587, No Longer Enrolling: 12/9/2023
Locations: Outpatient CTRC
More information available at ClinicalTrials.gov: NCT05305547

A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients with Chronic Kidney Disease

Assessment of dapagliflozin vs. placebo to slow the progression of kidney disease in patients with chronic kidney disease (CKD). Participation is expected to last between 1.5-4 years with 9-17 visits during that time. Compensation is provided.
Protocol #17-0412, No Longer Enrolling: 10/1/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03036150

Statin Therapy in Patients with Early Stage Autosomal dominant polycystic kidney disease


Protocol #17-0678, No Longer Enrolling: 3/31/2022
Locations: Colorado Research Center, Outpatient CTRC, Renal Research Center, University of Colorado Hospital

A Double-blind Randomized Parallel Group Study of the Efficacy and Safety of Tesevatinib in Subjects with Autosomal Dominant Polycystic Kidney Disease (KD019-211)


Protocol #17-0954, No Longer Enrolling: 5/4/2022
Locations: Colorado Research Center, Renal Research Center, University of Colorado Hospital

Daily Caloric Restriction and Intermittent Fasting in Overweight and Obese Adults with Autosomal Dominant Polycystic Kidney Disease


Protocol #17-1327, No Longer Enrolling: 7/8/2021
Locations: Anschutz Health and Wellness, UCD Anschutz Health & Wellness Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03342742

A Randomized Pilot Study of Treatment for Subclinical Antibody-Mediated Rejection in Kidney Transplant Recipients


Protocol #17-1812, No Longer Enrolling: 10/18/2019
Locations: University of Colorado Hospital

A Phase 3 Prospective, Randomized, Multi-Center, Open-Label, Controlled Trial to Assess the Efficacy and Safety of Cellular Immunotherapy with MDR-101 for Induction of Immune Tolerance in Recipients of HLA-Matched, Living Donor Kidney Transplants (the "Study")

MDR-101 is intended to induce mixed lymphohematopoietic chimerism and donor specific immune tolerance in order to preserve transplant kidney function, avert transplant kidney rejection, and eliminate the cumulative and serious side effects associated with IS drugs. Primary Objectives: To evaluate achievement of induction of functional immune tolerance by cellular immunotherapy with MDR-101 in recipients of human leukocyte an tigen (HLA)-matched, living donor kidney transplants. Functional immune tolerance is defined as remaining off of all immunosuppression (IS) drugs for 24 months or more after completion of anti-rejection, IS drug therapy withdrawal with no episodes of biopsy-proven acute rejection (BPAR), de novo donor-specific anti-HLA antibody (dnDSA) development, transplant kidney loss, or subject death. To compare the safety and tolerability of cellular immunotherapy with MDR-101 compared to conventional, standard-of-care (SOC) IS therapy in recipients of HLA-matched, living donor kidney transplants.
Protocol #17-1730, No Longer Enrolling: 6/12/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03363945

A Phase 2, Proof-of-Concept, Randomized, Double-Blinded, Placebo-Controlled Study of ACH-0144471 Treatment for 6 Months in Patients with C3 Glomerulopathy (C3G)

A Phase 2, Proof-of-Concept, Randomized, Double-Blinded, Placebo-Controlled Study of ACH-0144471 Treatment for 6 Months in Patients with C3 Glomerulopathy (C3G)
Protocol #17-2178, No Longer Enrolling: 5/28/2021
Locations: Childrens Hospital Colorado, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03369236

The Use of Acthar (ACTH) in Patients with Focal Segmental Glomerulosclerosis (FSGS) Who Have Developed Chronic Kidney Disease Stage V (CKD) or End Stage Renal Disease (ESRD) and are Undergoing Renal Transplant


Protocol #17-2336, No Longer Enrolling: 4/29/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02683889

Acute Kidney Injury and Vascular Function

This is a 12 week observational study of cognitive and blood vessel functioning 2 weeks and 12 weeks after an acute kidney injury.
Protocol #18-0654, No Longer Enrolling: 4/6/2021
Locations: University of Colorado Hospital

A Multicenter, Prospective, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study of ANG-3777 (formerly BB3) to Reduce the Severity of Delayed Graft Function in Recipients of a Deceased Donor Kidney

The study is a multicenter, prospective, double-blind, randomized, placebo-controlled, pivotal registration study. The Sponsor, Investigators and patients will all be blinded to study drug assignment. Patients in this study are at risk for requiring dialysis in the first week following transplantation of a kidney from a deceased donor and have early clinical indication of DGF based on poor renal function post-transplantation. Patients who fulfill all other eligibility criteria will be randomized in a 1:1 fashion to receive 2 mg/kg ANG-3777 or placebo (normal saline). Primary Objective: ? To demonstrate the safety and efficacy of ANG-3777 in reducing the severity of delayed graft function (DGF) in recipients at high risk of DGF after receiving a deceased donor renal allograft with DGF Secondary Objectives: ? To demonstrate the efficacy of ANG-3777 in optimizing renal function in recipients of a deceased donor renal allograft with DGF ? To demonstrate the efficacy of ANG-3777 in reducing length of hospital stay in recipients of a deceased donor renal allograft with DGF
Protocol #16-1038, No Longer Enrolling: 10/2/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02474667

A randomized double-blind placebo-controlled study to evaluate the efficacy and safety of CINRYZE? (C1 esterase inhibitor [human]) for the treatment of acute antibody-mediated rejection in kidney transplant patients 22Nov2017


Protocol #17-0275, No Longer Enrolling: 10/1/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02547220

A Phase 3b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of TRC101 in Delaying Chronic Kidney Disease Progression in Subjects with Metabolic Acidosis

This study will compare how well the study drug works in slowing the progression of kidney disease and how safe the study drug is when compared to placebo in chronic kidney disease patients with metabolic acidosis. The average duration of the study is anticipated to be about 3.5 years.
Protocol #18-1795, No Longer Enrolling: 7/20/2023
Locations: Colorado Research Center, Renal Research Center
More information available at ClinicalTrials.gov: NCT03710291

Multicenter, randomized, double-blind, placebo-controlled two stage study to characterize the efficacy, safety, tolerability and pharmacokinetics of GZ/SAR402671 in patients at risk of rapidly progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)

This is an international, multicenter trial. Participants will be given either active study drug or placebo and will be followed for a period of 2 years.
Protocol #18-1842, No Longer Enrolling: 9/22/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03523728

A 12 month, partially-blinded, active-controlled, multicenter, randomized study evaluating efficacy, safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) of an anti-CD40 monoclonal antibody, CFZ533, in de novo and maintenance kidney transplant recipients (CIRRUS I)

Study CCFZ533A2201 is a randomized, 12-month, active-controlled, partially-blinded, multicenter, dose range finding study to evaluate the efficacy, safety, tolerability, PK and PD of CFZ533 in 2 different cohorts: -In adult de novo kidney transplant recipients, CFZ533 in combination with MMF and corticosteroids as compared to standard of care comprised of tacrolimus, MMF and corticosteroids. -In a maintenance kidney transplant population (6-24 months post-transplant), CFZ533 in combination with MMF with or without corticosteroids, compared to a standard of care control arm of tacrolimus and MMF with or without corticosteroids. COHORT 1: Primary Objective(s) -To demonstrate that CFZ533 600 mg or 300 mg bi-weekly (Q2W), subcutaneous (SC), are non-inferior to a tacrolimus-based regimen with respect to the proportion of patients who experience the composite efficacy failure event (Biopsy proven acute rejection (BPAR), Graft Loss or Death) over 12 months post-transplantation. Key secondary objective: -To demonstrate that CFZ533 600 mg or 300 mg Q2W SC are superior to a tacrolimus-based regimen with respect to the mean estimated glomerular filtration rate (eGFR) at 12 months post-transplantation. COHORT 2: Primary Objective(s) -To demonstrate that CFZ533 450 mg Q2W SC is non-inferior to a tacrolimus-based regimen with respect to the proportion of patients who experience the composite event (BPAR, Graft Loss or Death) over 12 months post conversion. Key secondary objective: -To demonstrate that CFZ533 450 mg Q2W SC is superior to a tacrolimus-based regimen with respect to the mean change in eGFR from baseline to 12 months post conversion.
Protocol #18-2117, No Longer Enrolling: 6/12/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03663335

Phase 3, Randomized, Open-label, Controlled, Multiple-Dose, Efficacy, Safety, Pharmacokinetic, and Pharmacodynamic Study of Etelcalcetide in Pediatric Subjects 28 days to < 18 Years of age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis


Protocol #18-2337, No Longer Enrolling: 2/15/2022
Locations: Childrens Hospital Colorado

CLINICAL TRIALS IN ORGAN TRANSPLANTATION CTOT-21: Treg Adoptive Therapy in Subclinical Inflammation in Kidney Transplantation

This is an open label trial to determine the safety and efficacy of a single dose of autologous polyTregs in renal transplant recipients with SCI in the 3 to 7 months pos-transplant allograft biopsy compared to control patients treated with CNI-based immunosuppression. The efficacy of the Treg therapy will be assessed by the reduction of graft inflammation on biopsies performed at 7 months after study group allocation compared to the eligibility biopsy. Primary Safety Objective: This study will evaluate the safety of polyTregs in adult kidney transplant recipients. Secondary Safety Objective: Participants receiving polyTregs will be evaluated for the safety of converting from CNI‐based maintenance therapy to mTOR inhibitors after Treg therapy. Primary Efficacy Objective: This study will evaluate whether polyclonally expanded Tregs (polyTregs) reduce graft inflammation relative to their enrollment biopsy compared to those receiving CNI‐based maintenance therapy with similar baseline biopsy findings. Secondary Efficacy Objective: This study will evaluate whether polyTregs can reduce graft inflammation by 25% or more in the 2 weeks after polyTreg infusion relative to the enrollment biopsy.
Protocol #18-2679, No Longer Enrolling: 4/5/2023
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02711826

A randomized, controlled, multi-center, safety and efficacy study of FCR001 cell-based therapy relative to a tacrolimus and mycophenolate-based regimen in de novo living donor renal transplant recipients, and safety in FCR001 donors (the FREEDOM-1 study)

Evaluation of safety, efficacy and immunosuppression (IS) therapy following FCR001 cell therapy after kidney transplant vs. standard of care. FCR001 is a novel, cryopreserved allogeneic somatic cell therapy, derived from mobilized peripheral blood mononuclear cells from the same donor as the allograft, and containing hematopoietic progenitor cells, facilitating cells and alpha beta T cells. The rationale is to establish durable chimerism and donor-specific tolerance in the recipient enabling freedom from chronic IS and its associated toxicities. Primary Objective: To evaluate the proportion of FCR001 recipients who are free from IS, without biopsy-proven acute rejection (BPAR), at 24 months posttransplant. Key Secondary Objective: To evaluate the change in renal function (estimated glomerular filtration rate [eGFR] by Modification of Diet in Renal Disease (MDRD4) from post-transplant baseline (Month 1) to Month 24 in FCR001 recipients.
Protocol #19-1299, No Longer Enrolling: 9/30/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03995901

APOL1 Long-term Kidney Transplantation Outcomes Network

APOLLO is an observational study designed to assess the impact of RRVs in the APOL1 gene on the functional outcomes of kidneys transplanted from living and deceased donors with recent African ancestry and on the kidney function of living kidney donors with recent African ancestry in a prospective manner. In this protocol, recent African ancestry is broadly defined as African American, Afro-Caribbean, Hispanic black, and African. To test kidney donors and transplant recipients for forms of the APOL1 gene for purposes of evaluating how the various forms may impact both donors and recipients. To determine whether the presence of APOL1 RRVs in a kidney donor shortens death-censored renal allograft survival. Secondary Objectives: 1. Define whether the presence of APOL1 RRVs in a kidney donor is associated with worse renal function or greater proteinuria after transplantation of the kidney; 2. Define whether the presence of APOL1 RRVs is associated with worse renal outcomes in living kidney donors after nephrectomy, and; 3. (if donor APOL1 RRVs are associated with worse kidney function in recipients of renal allografts) identify modifying factors that increase susceptibility for shortened allograft survival, reduced renal allograft function or greater proteinuria in recipients of kidneys from donors with APOL1 high-risk genotypes. Modifying factors may include cause of death in the deceased donor, ischemia time, type of immunosuppression, graft rejection, viral infection, post-engraftment renal dysfunction, etc.
Protocol #19-0461, No Longer Enrolling: 9/22/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03615235

A Randomized, Placebo-Controlled, Phase 2 Study of HB-101, a Bivalent Cytomegalovirus (CMV) Vaccine, in CMV-Seronegative Recipient (R-) Patients Awaiting Kidney Transplantation from Living CMV-Seropositive Donors (D+)

This is a randomized, placebo-controlled, Phase 2 study of HB-101, a bivalent CMV vaccine, in CMV-seronegative recipient (R-) patients awaiting kidney transplantation from living CMV-seropositive donors (D+). The study population of the study is adult CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor, recruited globally from specified transplant centers. Primary Objectives: 1. To assess the safety and reactogenicity of HB-101 2. To assess the immunogenicity of HB-101 Secondary Objectives: 1. To assess the efficacy of the administration of at least 2 doses of HB-101 compared to that of placebo in mitigating CMV DNAemia/viremia for patients followed by CMV preemptive therapy post-transplant 2. To assess the efficacy of the administration of at least 2 doses of HB-101 compared to that of placebo in decreasing the use of anti-virals at treatment dose for patients to be treated prophylactically for CMV post-transplant 3. To assess additional immunogenicity parameters of HB-101
Protocol #18-1003, No Longer Enrolling: 6/2/2023
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03629080

Regulatory T Cell Modulation in Kidney Transplantation with Biologic Blockade of Dual Effector Pathways, CD28 and IL-6 (CTOT-24)

CTOT-24 is a multi-center, open-label, single arm clinical trial for kidney transplant recipients. This study will evaluate a new combination of 4 anti-rejection drugs to determine if it is safe and will prevent rejection of the transplanted kidney with fewer side effects than the standard treatment. Study participants will be enrolled prior to transplantation, will receive study drugs for one year after the transplant and will be followed for health status and kidney function for an additional year. Primary Objective: This study will evaluate the safety of the investigational agent lulizumab pegol (BMS-931699), administered with an immunosuppressive regimen that includes tocilizumab, in adult living-donor kidney transplant recipients in the first 6 months after transplantation. Secondary Objective: This study will also evaluate the safety of the study therapy regimen in adult living donor kidney transplant recipients 6 to 12 months after transplantation.
Protocol #19-2362, No Longer Enrolling: 8/3/2022
Locations: Outpatient CTRC, Pathology - SOM, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04066114

EVALUATION OF PATIENT OUTCOMES FROM THE KIDNEY ALLOGRAFT OUTCOMES ALLOSURE REGISTRY (KOAR)

This is a multicenter, non-blinded, prospective observational cohort study of 1000 patients enrolled in an AlloSure testing registry, including 300 patients at centers with planned renal surveillance biopsies at 12 months post-transplantation. The other 700 patients will be from centers that do not perform protocol surveillance biopsies. This registry study does not provide any medical care. Outcomes in this sub-cohort, which represents the majority of the intended use population in the U.S., will be compared to the outcomes of the test and control cohorts. Primary Safety Objective: To test the hypothesis that a strategy of monitoring for rejection that introduces AlloSure into clinical practice does not lead to inferior renal allograft outcomes when compared to a strategy of monitoring for rejection that does not include AlloSure. Primary Efficacy Objective: To test the hypothesis that a strategy of monitoring for rejection that introduces non-invasive AlloSure testing as part of clinical care results in a reduction in the number of renal biopsies performed when compared to a strategy of clinical care without the use of AlloSure testing. Secondary Safety Objectives: Include the assessment of other safety endpoints such as graft survival and graft function. Secondary Efficacy Objectives: To confirm AlloSure test performance characteristics in discrimination of active rejection and to describe the impact of AlloSure use and results on patient management.
Protocol #17-2267, No Longer Enrolling: 12/8/2023
Locations: University of Colorado Hospital

A PIVOTAL PHASE 3 TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF CLAZAKIZUMAB FOR THE TREATMENT OF CHRONIC ACTIVE ANTIBODY-MEDIATED REJECTION IN KIDNEY TRANSPLANT RECIPIENTS

This multi-center, randomized, double-blind, parallel-group, placebo-controlled, Phase 3 trial investigates whether clazakizumab (an anti-IL-6 mAb) may be beneficial for the treatment of CABMR in kidney transplant recipients by inhibiting the production of DSA and re-shaping T cell alloimmune responses. Subjects will be administered clazakizumab at a target dose of 12.5 mg (or placebo) by SC injection, Q4W for up to 260 weeks (or until allograft loss or death). Primary Objectives: 1. To evaluate the efficacy of clazakizumab in preventing all-cause composite allograft loss due to CABMR (defined as return to dialysis, allograft nephrectomy, re-transplantation, eGFR <15 mL/min/1.73 m2 or death from any cause (including death with functioning allograft). 2. To evaluate the efficacy of clazakizumab in slowing/preventing the progressive loss of kidney function (as measured by eGFR using the MDRD4 equation). 3. To evaluate the safety of clazakizumab. Secondary Objectives: 1. To evaluate the effects of clazakizumab on death-censored allograft loss (defined as return to dialysis, allograft nephrectomy, re-transplantation or eGFR <15 mL/min/1.73 m2 but excluding death from any cause). 2. To evaluate the effects of clazakizumab on albuminuria. 3. To evaluate the effects of clazakizumab on DSA titers and mean fluorescence intensity (MFI) scores. 4. To evaluate the effects of clazakizumab on incidence of acute rejection episodes (TCMR and ABMR). 5. To evaluate the effects of clazakizumab on the histology of kidney biopsies according to the Banff 2015 lesion grading scores. 6. To evaluate the effects of clazakizumab on overall patient survival. 7. To evaluate the effects of clazakizumab on healthcare utilization due to ABMR and patient reported outcomes, including health-related quality of life (HRQoL).
Protocol #19-0460, No Longer Enrolling: 11/29/2023
Locations: Outpatient CTRC, Pathology - SOM, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03744910

Kidney Immunosuppression Dosed Daily Only (KIDDO)


Protocol #17-2311, No Longer Enrolling: 10/21/2020
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT04156204

X-linked Hypophosphatemia Disease Monitoring Program (XLH-DMP)


Protocol #18-0225, No Longer Enrolling: 3/26/2020
Locations: Childrens Hospital Colorado

A Phase 3 Multicenter, Randomized, Double-Blinded, Placebo-Controlled Withdrawal Study Evaluating ADV7103 in Pediatric and Adult Subjects with Distal Renal Tubular Acidosis


Protocol #18-2100, No Longer Enrolling: 8/1/2020
Locations: Childrens Hospital Colorado

A Randomized, Multicenter, Double-Blind, Parallel, Active-Control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) (DUPLEX Study)


Protocol #17-2378, No Longer Enrolling: 2/20/2021
Locations: Childrens Hospital Colorado

A PHASE 3 TRIAL OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE

Each study subject will be randomized to receive either study drug or placebo for a total of 100 weeks, with the exception of a 4 week period between weeks 48 an 52, where no study drug is taken. Neither the subject nor the study staff will know which treatment was given until after the study finishes.
Protocol #19-2782, No Longer Enrolling: 6/3/2023
Locations: Brain Imaging Center (BIC), Outpatient CTRC, Renal Research Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03918447

A Phase 2 Study to Evaluate the Safety and Biologic Activity of APL-2 in Patients With IgA Nephropathy, Lupus Nephritis, Primary Membranous Nephropathy, or C3 Glomerulopathy (C3 Glomerulonephritis and Dense Deposit Disease)


Protocol #18-1723, No Longer Enrolling: 6/24/2020
Locations: Childrens Hospital Colorado

An adaptive seamless randomized, double-blind, placebocontrolled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients

Each study subject will be randomized to receive either study drug or a placebo for 6 months. Neither the subject nor the study staff will know which treatment was given until after the study has finished. Study subjects will be monitored every 2 weeks for the first month, then less frequently as the study progresses. The total length of the study is about 8 months.
Protocol #19-2819, No Longer Enrolling: 9/25/2020
Locations: Renal Research Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03373461

A PHASE 3, OPEN-LABEL, MULTICENTER STUDY OF ALXN1210 IN CHILDREN AND ADOLESCENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME (aHUS)


Protocol #17-0573, No Longer Enrolling: 6/4/2021
Locations: Childrens Hospital Colorado

A Phase 3, Prospective, Open-Label, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Paricalcitol Oral Solution for the Treatment of Secondary Hyperparathyroidism in Pediatric Subjects Ages 0 to 9 Years with Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis


Protocol #19-2333, No Longer Enrolling: 2/9/2021
Locations: Childrens Hospital Colorado

A Phase 2, Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of BMS-986165 with Background Treatment in Subjects with Lupus Nephritis

Each study subject will start with 12 weeks of treatment of MMF. After the 12 weeks of MMF, the subjects with an inadequate renal response may be randomized to one of the BMS-986165 treatment groups or placebo as add-on treatment to MMF. Subjects will be monitored and evaluated every 4 weeks for 52 weeks. Neither the subject or study staff will know which treatment was given until after the study has finished.
Protocol #19-2904, No Longer Enrolling: 7/13/2021
Locations: Renal Research Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03943147

Bicarbonate Administration and Cognitive Function in Midlife and Older Adults with CKD

This study is a 52 week intervention with visits at the CU Med Building on the Anschutz Medical Campus. Visits will include blood pressure checks, blood and urine collection, measurement of brain blood flow, measurement of cognitive function, and assessment of physical function via a questionnaire. Study purpose: This research study is being conducted to examine the effects of oral sodium bicarbonate therapy on blood vessel function in the brain and performance on cognitive tests. Study visits will take place at the Renal Research Office on the University of Colorado Anschutz Medical Campus. Participants will receive information regarding their overall health status; including testing for blood pressure, serum bicarbonate levels and kidney function levels. For more information, please contact Luis Perez at Luis.M.Perez@cuanschutz.edu or 303-724-1647
Protocol #20-1672, No Longer Enrolling: 7/22/2023
Locations: Renal Research Center

A Multicenter, Comparative Safety and Efficacy Study of ACTHar gel alone or in combination with oral Tacrolimus to reduce urinary proteinuria in patients with idiopathic DNAJB9 Positive Fibrillary glomerulopathy

Each patient will undergo 12 months of treatment with 17 patients randomized to ACTHar gel alone (17 patients) or to ACTHar gel plus oral Tacrolimus (17 patients) Year 2: Follow up and observation for 12 months OFF ACTHar gel or ACTHar gel and Tacrolimus
Protocol #19-2902, No Longer Enrolling: 12/3/2022
Locations: Renal Research Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04080076

The PROspera Kidney Transplant ACTIVE Rejection Assessment registry (ProActive) study

This is a non-treatment study that uses a blood test ("Prospera") to measure kidney function following transplant. This study will look at the usefulness of the Prospera testing compared to the usual serum creatinine testing done at regular intervals in kidney transplant recipients.
Protocol #19-2394, No Longer Enrolling: 9/22/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04091984

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients with ISN/RPS 2003 Class III or IV Lupus Nephritis

After a screening period of up to 28 days, eligible subjects will be randomized to receive blinded infusions of obinutuzumab 1000 mg or placebo on Day 1, and weeks 2,24,26,50,52 in three treatment groups. and will be assessed at week 76. Neither the subject or study staff will know which treatment was given until after the study has finished. Eligibility for subsequent infusions after week 76 will be determined based on the investigator's assessment of the adequacy of treatment response.
Protocol #20-0941, No Longer Enrolling: 6/3/2023
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04221477

DAPASALT: An Open Label, Phase IV, Mechanistic, Study to Evaluate the Natriuretic Effect of 2-Week Dapagliflozin treatment in Type 2 Diabetes Mellitus Patients with Impaired Renal Function


Protocol #20-0902, No Longer Enrolling: 8/5/2023
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04620590

A Phase 2a Multiple Ascending, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GFB-887, a TRPC5 Channel Inhibitor, in Patients with Diabetic Nephropathy, Focal Segmental Glomerulosclerosis, and Treatment-Resistant Minimal Change Disease

After each study subject qualifies, they will be assigned to one of the 5 treatment groups. The participants of each group will be given multiple doses of study drug at different dose levels. A computer will automatically assign the subject to one of the dose levels as well as whether the subject are placed in the placebo or active drug group. Neither the study doctor and study staff will know who is assigned to placebo or active drug.The total duration of this study is 26 weeks, and the study subject will have a total of 17 visits over this period
Protocol #20-1341, No Longer Enrolling: 12/3/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04235621

An Open-Label, Randomized, Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Pegcetacoplan in the Treatment of Post-Transplant Recurrence of C3G or IC-MPGN


Protocol #20-2106, No Longer Enrolling: 1/14/2023
Locations: Childrens Hospital Colorado, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04572854

A Double-blind Randomized Placebo-controlled Parallel Design Multicenter Phase IIIb Study of the Effect of Sodium Zirconium Cyclosilicate (SZC) on Serum Potassium and Serum Bicarbonate in Pateitns with Hyperkalemia and Metabolic Acidosis Associated with Chronic Kidney Disease (NEUTRALIZE)

This is a 36 day trial with 8 in-person visits comparing the effect of Lokelma vs. placebo on serum potassium and bicarbonate levels.
Protocol #21-2470, No Longer Enrolling: 4/7/2023
Locations: Renal Research Center
More information available at ClinicalTrials.gov: NCT04727528

CMV and CMV-Immune Responses in Geriatric Conditions Post-Kidney Transplant (CMV-GeriKT)


Protocol #21-2602, No Longer Enrolling: 9/16/2023
Locations: Outpatient CTRC, Outpatient CTRC

An open-label, long-term study of GFB-887 in Patients with Glomerular Kidney Disease

To evaluate long-term safety and tolerability of GFB-887; to evaluate treatment effect; to evaluate remission status
Protocol #22-0267, No Longer Enrolling: 12/3/2022
Locations: Renal Research Center

Nicotinic agonist effects on BMI and neuronal response in overweight/obese adults

This study plans to learn more about the effects of an investigational new drug (DMXB-A) and its effects on obesity. The study drug has similar effects to nicotine. Since nicotine has been found to effect appetite, we are interested in studying the effects of the study drug, which has similarities to nicotine, on how your brain responds to such things as pictures of food. This study drug has not been approved by the Food and Drug Administration (FDA), and is considered experimental. This research study plans to examine the effects of an investigational new drug on neuronal, physiological, and behavioral mechanisms of obesity in the general population.
Protocol #15-0650, No Longer Enrolling: 12/31/2021
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02458313

Setmelanotide (RM-493) Phase 2 Treatment Trial in Patients with rare genetic disorders of obesity


Protocol #17-0373, No Longer Enrolling: 6/24/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03013543

Neural Effects of Negative Affect on Food Choices and Reward Processing In Individuals with Binge Eating Episodes

The goal of this study is to learn more about how brain function drives binge eating, a condition where individuals eat unhealthy large amounts of food
Protocol #16-2658, No Longer Enrolling: 10/1/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03393039

Pilot study of time restricted feeding as a weight loss intervention in overweight and obese adults


Protocol #18-0487, No Longer Enrolling: 2/27/2020
Locations: Anschutz Health and Wellness, UCD Anschutz Health & Wellness Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03571048

Obalon? Balloon System, The Post Approval Study

The aim of the study is to show that the device demonstrates continued performance and safety in a commercial setting. Efficacy of the Six Month Obalon Balloon System will be evaluated utilizing the standard weight loss metrics. Patients will be followed for 12 months (6- months Device therapy and 6-months post-removal). The primary objective is to collect additional safety data with the Obalon Balloon System and confirm the existing safety profile results gathered in PTL-1100-0013, the Obalon Pivotal Study.
Protocol #18-1209, No Longer Enrolling: 9/2/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03570034

The Effects of Resistance Training on Appetite Regulation

In this study we will be evaluating how your brain responds to food images, as well as how your behaviors and hormones change with a 12-week resistance training intervention.
Protocol #18-1298, No Longer Enrolling: 1/26/2022
Locations: Anschutz Health and Wellness, UCD Anschutz Health & Wellness Center, University of Colorado Hospital

The use of Libre to educate, motivate and activate adults with newly diagnosed type 2 diabetes to improve metabolic control and reduce their reliance on medication: A pilot study.

What will be asked of you: Eligible participants will be asked to follow a lifestyle program for a total of 4 months, complete one (virtual) assessment, and complete questionnaires at the beginning and end of the study. All participants will receive: - A Freestyle Libre 2 continuous blood glucose meter and supplies for 3 months - A Fitbit? activity monitor - A treatment manual and diary The goal is to study a non-medication treatment for adults newly diagnosed with Type 2 Diabetes (T2D) that uses a lifestyle program and continuous glucose monitoring to see if this reduces or prevents the need for diabetes medications.
Protocol #20-2470, No Longer Enrolling: 12/4/2021
Locations: Department Specific Free Standing Clinic

ASPIREASSIST POST APPROVAL STUDY


Protocol #17-0195, No Longer Enrolling: 2/16/2023
Locations: University of Colorado Hospital

Protocol Title: Efficacy and safety of cagrilintide s.c. 2.4 mg in combination with semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) once-weekly in participants with overweight or obesity (Study ID: NN9838-4608)

Participants will be randomly assigned to one of four treatment options (CagriSema, or Cagrilintide alone, Semaglutide alone, or placebo) and will receive monthly dietary counseling during the 75 week main study.
Protocol #22-1393, No Longer Enrolling: 6/17/2023
Locations: Anschutz Health and Wellness, Outpatient CTRC
More information available at ClinicalTrials.gov: NCT05567796

Development of My Plan, an adaptive mobile health intervention for adolescents with obesity


Protocol #21-2817, No Longer Enrolling: 11/4/2023
Locations: Childrens Hospital Colorado

Familial Hyperlipidemia Registry


Protocol #22-1979, No Longer Enrolling: 10/27/2023
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital

A Master Protocol to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants without Type 2 Diabetes who have Obesity or Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial (TRIUMPH-1)


Protocol #23-0833, No Longer Enrolling: 12/1/2023
Locations: Anschutz Health and Wellness, Outpatient CTRC
More information available at ClinicalTrials.gov: NCT05929066

A Phase 2a, Randomized, Open-Label, Active Control, Multi- Center Study to Assess the Efficacy and Safety of ASKP1240 in de novo Kidney Transplant Recipients

The primary objectives of this study are: - to compare the efficacy of basiliximab induction, ASKP1240, mycophenolate mofetil [MMF], and steroids to the standard of care immunosuppressive regimen (basiliximab induction + tacrolimus + MMF + steroids) [CNI avoidance]. - to compare the efficacy of basiliximab induction, ASKP1240, tacrolimus, and steroids to the standard of care immunosuppressive regimen (basiliximab induction + tacrolimus + MMF + steroids) [CNI minimization- MMF avoidance]. The secondary objectives of this study are: - to compare the safety of the experimental arms to the standard of care arm. -to evaluate the long term safety and tolerability of ASKP1240 administration in subjects in the Long Term Extension (LTE) period of the study.
Protocol #13-0061, No Longer Enrolling: 10/1/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT01780844

Helping Ourselves, Helping Others: The Young Women's Breast Cancer Study

This study plans to learn more about breast cancer in young women, including the biology of the disease and young women's experiences with it. We aim to use this information to improve the care and information available for young women with breast cancer.
Protocol #08-1222, No Longer Enrolling: 2/12/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT01468246

Quantification of Pain Sensitivity to Controlled Objective Pain Stimuli


Protocol #07-0354, No Longer Enrolling: 2/13/2021

Inter-Segmental Coordination and Ankle-foot Orthoses during Gait by Children with Spastic Cerebral Palsy


Protocol #10-1084, No Longer Enrolling: 10/2/2021

The Chest Wall And Spine Deformity Registry


Protocol #11-1248, No Longer Enrolling: 10/24/2019

REAL Athlete Injury Tracking Database


Protocol #11-1640, No Longer Enrolling: 6/30/2021

Autograft plus Allograft Hybrid ACL Reconstruction


Protocol #12-0144, No Longer Enrolling: 1/6/2021

Health Related Quality of Life and Surgical Outcomes of Patients Attending Amputee and Deformity Clinic (Amputee Database)


Protocol #12-1525, No Longer Enrolling: 11/1/2019

Chronic Recurrent Multifocal Osteomyelitis (CRMO): Functional Outcomes and Quality of Life in Patients Undergoing Treatment


Protocol #12-1557, No Longer Enrolling: 11/1/2019

A prospective, post-market, clinical outcomes of the Secur-Fit Advanced Hip Stem by Stryker Orthopedics-Total Hip Arthroplasty

Primary Objective: - 5-year success rate of the Secur-Fit Advanced Hip Stem with an endpoint of revision for aseptic loosening or femoral fracture will be compared with a 99% success rate, with a 2.5% noninferiority margin.
Protocol #14-0447, No Longer Enrolling: 4/4/2023
Locations: Colorado Research Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT01917929

Multicenter Prospective Cohort Study on Current Treatments of Legg-Calve-Perthes Disease


Protocol #13-0101, No Longer Enrolling: 11/1/2019

The Use of Casting in Patients with Infantile Scoliosis


Protocol #13-2952, No Longer Enrolling: 10/24/2019

Quantification of the variable expression of estrogen receptors in human articular cartilage of healthy versus osteoarthritic females


Protocol #14-1971, No Longer Enrolling: 1/6/2021

Impact of Neck Strengthening Program in Adolescent Athletes


Protocol #14-0712, No Longer Enrolling: 6/30/2021

Analysis of prognostic cell signaling factors in Adolescent Idiopathic Scoliosis


Protocol #14-0884, No Longer Enrolling: 10/24/2019

Women with Cancer Survivorship Outcomes Program (WCSOP)


Protocol #15-1397, No Longer Enrolling: 11/23/2019
Locations: University of Colorado Hospital

S0820 A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients with Stage 0-III Colon or Rectal Cancer, Phase III-Preventing Adenomas of the Colon with Eflornithine and Sulindac (PACES). Amendment 3 7.15.18


Protocol #15-1590, No Longer Enrolling: 7/1/2023
Locations: Cherry Creek Medical Center, Memorial Hospital Central, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT01349881

Biobank Protocol to Store Specimens and Data on Eligible Subjects that Consented to COMIRB Protocol 13-1744


Protocol #15-1676, No Longer Enrolling: 10/22/2019

Retrospective Review of Minimally Invasive Placement of Pedicle Screws in Spine Surgery


Protocol #14-0654, No Longer Enrolling: 10/2/2021

15-1621 A Phase 0 Trial of Gemcitabine in Newly-Diagnosed Diffuse Intrinsic Pontine Glioma


Protocol #15-1621, No Longer Enrolling: 3/10/2020
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02992015

Safety and Efficacy of Pulsed Electromagnetic Fields (Cervical-Stim?) as an Adjunct to Enhance Union in Conservatively Treated Type II Fractures of the Odontoid Process


Protocol #14-2369, No Longer Enrolling: 11/3/2021

15-2069 Using the Neurologic Assessment in Neuro-oncology (NANO) Scale as a Predictive Assessment Tool for Survival in Malignant Glioma


Protocol #15-2069, No Longer Enrolling: 10/1/2019
Locations: University of Colorado Hospital

A221405 POSITIVE (Pregnancy Outcome and Safety of Interrupting Therapy for women with endocrine responsive breast cancer)


Protocol #15-2078, No Longer Enrolling: 1/17/2020
Locations: Greeley Hospital, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02308085

Review of Outcomes of Bone Marrow Transplant (BMT) Patients


Protocol #15-2279, No Longer Enrolling: 11/28/2019

Functional Connectivity of the Basal Ganglia in Primary Focal Dystonia

In this study we are looking at how the brain works in people who have dystonia compared to those who don't have dystonia. This study will use magnetic resonance imaging (MRI), magnetoencephalography (MEG), and Electroencephalography (EEG) to see how the brain reacts while resting and doing a finger-tapping task. Aim 1: A second level contrast between Primary Focal Dystonia (PFD) and Healthy Controls (HC) of the statistical parametric maps of correlation coefficients at rest and during a tapping motor task Aim 2: the strength of correlation between basal ganglia motor network functional connectivity measures and total PFD clinical assessment scale scores
Protocol #12-0289, No Longer Enrolling: 2/4/2021
Locations: Colorado Research Center, Department Specific Free Standing Clinic, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT01761903

APEC14B1 The Project: Every Child Protocol: A Registry, Eligibility Screening, Biology and Outcome Study


Protocol #15-2012, No Longer Enrolling: 12/22/2023
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02402244

15-0963 Analysis of Biofluid Extracellular Vesicles from Brain Tumor Patients


Protocol #15-0963, No Longer Enrolling: 10/22/2019

G1T28 Biobanking


Protocol #15-1187, No Longer Enrolling: 10/22/2019

Comparative Analysis of Intraosseous and Soft Tissue Meningiomas


Protocol #15-1106, No Longer Enrolling: 10/22/2019

Department of Otolaryngology Biobank


Protocol #14-0269, No Longer Enrolling: 6/30/2023
Locations: University of Colorado Hospital

Retrospective Analysis of "Second-Look" (Re-Staging) Transurethral Resection on the Development of Bladder Cancer and the Difference in Cost of Care for Patients with and without Second Look Resection


Protocol #16-1023, No Longer Enrolling: 11/7/2019
Locations: University of Colorado Hospital

I3Y-MC-JPCE Phase 1b Study of Abemaciclib in Combination with Pembrolizumab for Patients with Stage IV Non-Small Cell Lung Cancer or Hormone Receptor Positive, HER2 Negative Breast Cancer


Protocol #16-0705, No Longer Enrolling: 9/22/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02779751

An Intermediate-size, Expanded Access Protocol to Provide Brincidofovir for the Treatment of Serious Adenovirus Infection or Disease (PROTOCOL No. CMX001-351)


Protocol #16-0225, No Longer Enrolling: 6/29/2021
More information available at ClinicalTrials.gov: NCT02596997

Successful use of EPOCH-R in two pediatric patients with Burkitts Lymphoma and Acute Kidney Injury: a case report


Protocol #16-0907, No Longer Enrolling: 11/23/2019
Locations: Childrens Hospital Colorado

Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE) V: 6.0; 12Sept2018


Protocol #15-0537, No Longer Enrolling: 8/22/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02381509

A Pilot Clinical Trial of Genomic Based Assignment of Therapy in Advanced Urothelial Carcinoma


Protocol #16-1082, No Longer Enrolling: 10/18/2019
Locations: University of Colorado Hospital

Patient-Initiated Biobanking of Deceased Lung Cancer Patient Tissues

To collect archival tissues and validated clinical history of deceased Lung cancer patients & deposit them into the NCI SPORE biobank
Protocol #15-1294, No Longer Enrolling: 11/23/2019
Locations: Department Specific Free Standing Clinic, University of Colorado Cancer Center

AOST1421 A Phase II Study of Human-Mouse Chimeric Anti-Disialoganglioside Monoclonal Antibody ch14.18 (Dinutuximab, NSC#764038, IND#4308) in Combination with GM-CSF in Patients with Recurrent Osteosarcoma


Protocol #15-2393, No Longer Enrolling: 5/22/2020
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02484443

Apollo Onyx Delivery Micro Catheter Post Market Safety Study


Protocol #14-2270, No Longer Enrolling: 10/1/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02378883

BIPM Biorepository Project (BBP)/ Rocky Mountain Biorepository (RMB)


Protocol #15-0461, No Longer Enrolling: 11/9/2019
Locations: Boulder Health Center, Cherry Creek Medical Center, Greeley Hospital, Harmony Campus, Lone Tree Medical Center, Longs Peak Hospital, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Pikes Peak Regional Hospital, Poudre Valley Hospital, Steadman Hawkins Clinic - Denver, UCHealth Internal Medical Clinic - Lowry, UCHealth Stapleton Medical Center, University of Colorado Hospital

Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations

1. To determine which pharmaceutical therapy is most effective and causes the fewest side effects in CSPN. 2. To determine which drug has the fewest and which has the most side effects.
Protocol #14-2157, No Longer Enrolling: 10/1/2019
Locations: University of Colorado Hospital

The Impact of Vocal Folds Augmentation with Injection Laryngoplasty on Quality of Voice in Patients with Parkinson Disease (VoCAL-PD ? Vocal Cords Augmentation Laryngoplasty in PD)

1. To assess the effect of vocal folds augmentation with long acting calcium hydroxyapatite paste on the quality of voice in PD subjects. 2. To assess the effect of vocal folds augmentation with long acting calcium hydroxyapatite paste on structural and functional parameters of the larynx measured on videostroboscopic recordings assessing glottic closure time and supraglottic constriction. 3. Assess the duration of the long term treatment effect.
Protocol #16-1127, No Longer Enrolling: 5/11/2021
Locations: University of Colorado Hospital

ADVL1412 A Phase 1/2 Study of Nivolumab (IND#124729) in Children, Adolescents, and Young Adults with Recurrent or Refractory Solid Tumors as a Single Agent and in Combination with Ipilimumab


Protocol #16-1285, No Longer Enrolling: 4/15/2020
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02304458

RANDOMIZED PHASE III TRIAL EVALUATING THE ROLE OF WEIGHT LOSS IN ADJUVANT TREATMENT OF OVERWEIGHT AND OBESE WOMEN WITH EARLY BREAST CANCER


Protocol #16-1240, No Longer Enrolling: 3/10/2021
Locations: Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02750826

WHOLE BLOOD SPECIMEN COLLECTION FROM PREGNANT SUBJECTS (PRO-101-SAMPLES)

To obtain whole blood specimens from pregnant subjects to be used for research and development and clinical validation studies of prenatal assays.
Protocol #16-0911, No Longer Enrolling: 1/21/2021
Locations: Childrens Hospital Colorado, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02430584

Tumor Genetics as Predictors of Response to Stereotactic Radiosurgery (SRS) in Melanoma Brain Metastases


Protocol #16-0908, No Longer Enrolling: 11/23/2019
Locations: University of Colorado Hospital

Effects of Antidepressant Medication Use in Glioblastoma Multiforme


Protocol #16-0895, No Longer Enrolling: 11/23/2019
Locations: University of Colorado Hospital

NANT 2015-01: Neuroblastoma Precision Trial


Protocol #16-0932, No Longer Enrolling: 11/19/2020
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02868268

Evaluation of Colorado Oncology Providers on the Use of Medical Marijuana


Protocol #16-1541, No Longer Enrolling: 11/20/2019
Locations: University of Colorado Hospital

Malglycemia in the Pediatric Hematopoietic Stem Cell Transplant Population


Protocol #16-1496, No Longer Enrolling: 11/23/2019
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03482154

Mediators of Perceived Exercise Effort in Type 2 Diabetes - Barriers to Physical Activity


Protocol #11-0909, No Longer Enrolling: 7/6/2021

When is enough, enough? Investigating end-of-life care provided to HSCT recipients


Protocol #16-1714, No Longer Enrolling: 11/23/2019
Locations: University of Colorado Hospital

Bromocriptine QR as adjunct therapy in Type 1 Diabetes


Protocol #15-1309, No Longer Enrolling: 12/27/2019
Locations: CTRC-adult, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02544321

A prospective, single blinded, multi-center, randomized, controlled, pivotal study to assess the safety and effectiveness of the InSpace device for treatment of full thickness Massive Rotator Cuff Tears


Protocol #15-1348, No Longer Enrolling: 10/1/2019
More information available at ClinicalTrials.gov: NCT02208440

Skin cancer prevention in a young adult population - nevus excision


Protocol #16-1782, No Longer Enrolling: 10/8/2020
Locations: University of Colorado Hospital

Comparison of Prolaris and Oncotype Dx Genomic Prostate Cancer Tests


Protocol #16-2525, No Longer Enrolling: 11/23/2019
Locations: University of Colorado Hospital

Prostate Cancer and Prospect of Brain Metastases Development


Protocol #16-1884, No Longer Enrolling: 10/22/2019
Locations: University of Colorado Hospital

Genomics and Proteomics of Chemosensitivity in Bladder Cancer


Protocol #16-1983, No Longer Enrolling: 10/22/2019
Locations: University of Colorado Hospital

Effect of Metformin on Vascular and Mitochondrial Function in Type 1 Diabetes


Protocol #11-0693, No Longer Enrolling: 12/27/2019
Locations: CTRC-adult, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT01813929

Role of vascular function: oxygen delivery vs oxygen utilization in the exercise impairment in type 2 diabetes


Protocol #06-0062, No Longer Enrolling: 10/1/2019
Locations: CTRC-adult, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT01793909

Impact of sitagliptin on cardiovascular exercise performance in type 2 diabetes


Protocol #13-2015, No Longer Enrolling: 10/4/2019
Locations: CTRC-adult
More information available at ClinicalTrials.gov: NCT01951339

The Oncoshare Project: An integrated informatics approach to understanding breast cancer survival.


Protocol #16-2276, No Longer Enrolling: 11/23/2019

Molecular Analysis of Drug Sensitivity and Resistance in Advanced Thyroid Cancer


Protocol #16-0868, No Longer Enrolling: 11/23/2019
Locations: University of Colorado Hospital

Amyloid Imaging with 11C-PiB in Healthy Aging and Mild Cognitive Impairment


Protocol #16-2064, No Longer Enrolling: 8/3/2022
Locations: University of Colorado Hospital

A011502: A RANDOMIZED PHASE III DOUBLE BLINDED PLACEBO CONTROLLED TRIAL OF ASPIRIN AS ADJUVANT THERAPY FOR HER2 NEGATIVE BREAST CANCER: THE ABC TRIAL


Protocol #16-2437, No Longer Enrolling: 12/5/2020
Locations: Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02927249

Multicenter, Open-Label, Phase 3 Study of Tabelecleucel for Allogeneic Hematopoietic Cell Transplant Subjects with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease after Failure of Rituximab (MATCH Study)


Protocol #16-2448, No Longer Enrolling: 9/30/2020
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03392142

Colorectal Cancer Incidence Trends in Colorado


Protocol #16-2487, No Longer Enrolling: 10/24/2019
Locations: University of Colorado Hospital

S1418/BR006, A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with greater than 1 cm Residual Invasive Cancer or Positive Lymph Nodes (greater than pN1mic) After Neoadjuvant Chemotherapy.


Protocol #16-2594, No Longer Enrolling: 8/19/2021
Locations: Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02954874

Automated Three Dimensional Morphologic Analysis of Sputum Cells for the Diagnosis of Lung Cancer


Protocol #16-2160, No Longer Enrolling: 11/23/2019
Locations: Rocky Mountain Regional VA Medical Center, University of Colorado Hospital

Survey of Protocol Review and Monitoring Systems in U.S. Cancer Centers


Protocol #16-2755, No Longer Enrolling: 10/22/2019
Locations: University of Colorado Hospital

a characterization of the effect of total knee arthroplasty on glycemic control in the VA population


Protocol #15-2242, No Longer Enrolling: 1/15/2021

a retrospective review of regional variation in pediatric musculoskeletal infection


Protocol #15-2466, No Longer Enrolling: 3/10/2021

BIOMARKERS IN BARRETT'S ESOPHAGUS AND ESOPHAGEAL ADENOCARCINOMA: THE TREAT-BE (TREATMENT WITH RESECTION AND ENDOSCOPIC ABLATION TECHNIQUES FOR BARRETT'S ESOPHAGUS) CONSORTIUM BIOBANK


Protocol #16-2636, No Longer Enrolling: 11/26/2019
Locations: University of Colorado Hospital

A Review of the Incidence of CNS Metastasis in Prostate Cancer and Possible Pharmaceutical Links to Increasing Occurrence


Protocol #17-0192, No Longer Enrolling: 10/1/2019
Locations: University of Colorado Hospital

STRENGTH: Seeking To Reactivate Esophageal aNd Gastric Treatment Health


Protocol #16-2228, No Longer Enrolling: 11/26/2019
Locations: University of Colorado Hospital

Factors mediating gut microbiota dysbiosis and metabolic disease in HIV patients.

This study plans to learn more about immune responses in intestinal (gut) tissue in people with human immunodeficiency virus (HIV) infection. This study will determine whether change in the composition of gut bacteria in HIV infected individuals is related to a high prevalence of chronic gut inflammation and metabolic disease. The investigators will also investigate immune-modulatory properties of specific bacteria that correlate with disease both by characterizing which functional genes are selected for in their genomes and by stimulating immune cells isolated from blood and gut tissue with bacterial isolates. This work will establish whether gain/loss of bacterial drivers/suppressors of information in the gut contributes to metabolic disease in HIV-infected individuals.
Protocol #14-1595, No Longer Enrolling: 10/4/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02258685

Effect of Interferon gamma 1-b (IFN-gamma 1b) on Innate Immune Cells

The investigators hypothesize that neutrophils and monocytes developed under the influence of Interferon- gamma-1b (IFN-gamma-1b, Actimmune(R) in vivo will display enhanced function across a broad range of activities related in large part to the transcriptional activation effects of this cytokine. The investigators will evaluate the effects of IFN-? in healthy human subjects in vivo on gene expression, biologic activity markers, and functional activity of myeloid cells in single dose studies and in steady state studies.
Protocol #15-1643, No Longer Enrolling: 10/1/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02609932

CD8+ T-cell Responses to a Conserved Herpesvirus Epitope After Natural Infection, Vaccination, or Reactivation with Human Herpesviruses


Protocol #13-2122, No Longer Enrolling: 4/6/2021
Locations: University of Colorado Hospital

Exercise for Healthy Aging

The primary objective of this proposal is to compare a moderate or high intensity exercise intervention to improve physical function in persons aging with Human Immunodeficiency Virus (HIV).
Protocol #14-2207, No Longer Enrolling: 10/4/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02404792

IMPAACT 2012: Phase I Placebo-Controlled Study of the Infectivity, Safety and Immunogenicity of a Single Dose of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, LID cp AM2-2, Lot RSV#009B, Delivered as Nose Drops to RSV-Seronegative Infants 6 to 24 Months of Age, Version 1.0


Protocol #16-1564, No Longer Enrolling: 12/17/2019

PTH And Calcium Responses to Exercise (PACE) in Older Adults

The primary goal of this research is to find out if exercise that causes the loss of calcium from the blood, possibly through the sweat, also causes the release of calcium from the bones.
Protocol #15-0250, No Longer Enrolling: 5/20/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02468817

Female Influences on the Etiology of Rheumatoid Arthritis (FIERA) Study

1. To establish the relationship between exposure to certain female factors (e.g. contraceptive, menstrual, pregnancy and sexual history) and the presence of serum RA-related autoimmunity and/or RA-related immunologic factors in subjects with RA, subjects at-risk for RA, and control subjects. These evaluations will include baseline and longitudinal studies to determine incident development of RA-related autoimmunity. 2. To determine the prevalence of RA-related biomarkers, such as Abs and inflammatory cytokines, in the lower female genital tract in women with RA, women at-risk for RA, and controls. These evaluations will include baseline and longitudinal studies to determine incident development of RA-related autoimmunity at the CV mucosa. 3. To evaluate microbial communities in the lower female genital tract of women with RA, women at-risk for RA, and control subjects. These evaluations will include baseline and longitudinal studies of microbiota as well as comparison to serum and CV biomarkers. 4. To simultaneously compare RA-related Abs and immunologic biomarkers in the female genital tract and serum in women with RA, women at-risk for RA and control subjects. These evaluations include cross-sectional and longitudinal studies to determine evolution over time at each site (CV fluid and serum) to determine incident development of RA-related autoimmunity. 5. To demonstrate specific immunologic mechanisms of RA-related Ab generation in the cervical and uterine mucosa associated with systemic or mucosal RA-related Abs in women who had previously obtained and stored cervical or uterine tissue. 6. To compare the performance of self-collected and investigator-collected CV samples for detection of mucosal immunity and microbiota.
Protocol #14-1751, No Longer Enrolling: 10/4/2019
Locations: University of Colorado Hospital

Bioequivalence of tenofovir and emtricitabine following over-encapsulation

The goal of this study is to determine whether the use of the PSS with Truvada will vary the drug concentrations of FTC/TDF.
Protocol #16-1478, No Longer Enrolling: 10/16/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02968576

An investigation of the neural and executive function underpinnings of severe worry among adolescents

This study seeks to improve our understanding of worry among adolescents.
Protocol #15-1593, No Longer Enrolling: 1/14/2022

Feasibility Study of Metformin Therapy in ADPKD V: 6.20.2017

The primary purpose of the research study is to determine the safety and tolerability of the study drug (Metformin or placebo) when given to subjects with ADPKD (Autosomal Dominant Polycystic Kidney Disease).
Protocol #16-0802, No Longer Enrolling: 7/6/2021
Locations: Department Specific Free Standing Clinic, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02903511

EFFECTS OF SERUM FATTY ACID LOWERING ON INSULIN SENSITIVITY, CARDIOVASCULAR FUNCTION, AND EXERCISE CAPACITY IN NON-INSULIN DEPENDENT DIABETES

To research the effects of an investigational drug on exercise capacity and blood vessel function​.​
Protocol #10-1393, No Longer Enrolling: 5/18/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT01580813

Effectiveness Analysis of Natalizumab versus Fingolimod using Patient-Reported Outcomes in Patients with Multiple Sclerosis

The purpose of this study is to compare two medications, natalizumab and fingolimod, used in the treatment of multiple sclerosis (MS) through a variety of previously validated patient reported outcomes (PROs).
Protocol #13-2767, No Longer Enrolling: 7/6/2021
Locations: University of Colorado Hospital

Qualitative Needs Assessment for a Hospice Care Decision Aid


Protocol #16-0479, No Longer Enrolling: 10/2/2021
Locations: Denver Health and Hospital Authority, University of Colorado Hospital

Pilot Study to Examine the Impact of Overfeeding on Peripheral Clock Gene Expression in Humans

The overall goal of this pilot project is to take the first steps toward developing translational methods to investigate links between changes in energy flux and the circadian system in human tissues.
Protocol #15-1570, No Longer Enrolling: 12/27/2019
Locations: CTRC-adult, Denver Health Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02809482

Insular Inhibitory Neuromodulation to Reduce Cigarette Craving and Alter Brain Function in Smokers

The goal of this study is to determine if a specific experimental brain stimulation technique can be used as a non-invasive way to reduce cigarette cravings in current smokers.
Protocol #15-1016, No Longer Enrolling: 6/30/2021
More information available at ClinicalTrials.gov: NCT02590640

Heart Sounds at Home: Prospective Maternal Surveillance of SSA Positive Pregnancies Using a Hand-Held Fetal Heart Rate Monitor

The purpose of the research study "Heart Sounds at Home" is for pregnant SSA or SSA/SSB (Sjogren syndrome B) antibody positive mothers to use a Doppler fetal heart rate monitor to detect abnormal heart rates and rhythms in their babies before they are born.
Protocol #13-1879, No Longer Enrolling: 5/1/2021
More information available at ClinicalTrials.gov: NCT02920346

Eosinophils and Gastrointestinal Inflammation

Determine the efficacy of the EnteroTracker String Test (EST)for monitoring inflammation in the esophagus. Compare analysis of the EST to biopises taken during an upper endoscopy.
Protocol #07-0223, No Longer Enrolling: 12/31/2019
Locations: Childrens Hospital Colorado, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02008903

A phase III, open label, multicenter study to evaluate the impact of reactogenicity on Quality of Life (QoL), after intramuscular administration of GSK Biologicals candidate Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A) in adults > or = 50 years of age


Protocol #16-1787, No Longer Enrolling: 6/30/2021

Effectiveness of Therapy via Telemedicine following Cochlear Implants

This research plans to learn more about the use of telemedicine as a means of providing therapy to children who have a cochlear implant(s). While Auditory-Verbal Therapy has typically been delivered in person, many people are starting to access therapy over the internet. We are conducting this research to determine if the outcomes of therapy are the same when AVT is delivered in person and via telemedicine.
Protocol #12-1103, No Longer Enrolling: 9/21/2021

Phosphate Lowering to Treat Vascular Dysfunction in Chronic Kidney Disease


Protocol #13-0328, No Longer Enrolling: 10/2/2021
More information available at ClinicalTrials.gov: NCT02209636

Mechanisms of Vascular Dysfunction in CKD and ADPKD: A Cross-Sectional Study

This research study will compare blood vessel function in healthy adults to adults with two different types of kidney disease. The testing visit will include non-invasive testing of blood vessel function and collection of blood and cells from an IV.
Protocol #15-0869, No Longer Enrolling: 7/6/2021

Cath Lab Data Collection Study


Protocol #RRR16-1481, No Longer Enrolling: 12/20/2023
Locations: University of Colorado Hospital

Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohns Disease V: 05 March 2018


Protocol #16-2456, No Longer Enrolling: 11/17/2022
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02914561

Cardiovascular Mechanisms of Exercise Intolerance in Diabetes and the Role of Sex

Participants will undergo baseline testing of heart and blood vessel function as well as skeletal muscle function and exercise ability. Participants will then do cardiovascular exercise for 15 weeks, and all testing will be repeated. Testing includes cardiac ultrasound, exercising on a stationary bicycle, tests of insulin sensitivity, muscle biopsy, and MRI. Total duration of participation will last approximately 6 months. This study will define the relationship of cardiac, vascular function and skeletal muscle blood flow (individually and together) to cardiovascular exercise capacity in in men and women with and without type 2 diabetes (T2DM). Identification of differences in the effects of exercise training on the integrated cardiovascular system and metabolism in men and women with and without T2DM will reveal specific adaptive responses to exercise. This study will evaluate & compare exercise function in a total of 60 subjects from the Denver area (30 people with T2DM and 30 overweight control subjects).
Protocol #17-0356, No Longer Enrolling: 3/16/2023
Locations: Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03419195

Inotuzumab Ozogamicin Compassionate Access Single IND


Protocol #16-2747, No Longer Enrolling: 3/10/2020
Locations: Childrens Hospital Colorado

ALTE1621 Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Heart Failure (PREVENT-HF): A Phase 2b Randomized Placebo-Controlled (Carvedilol) Trial


Protocol #17-0486, No Longer Enrolling: 1/22/2021
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02717507

A NOVEL APPROACH TO INFANTILE SPASMS: COMBINED COSYNTROPIN INJECTABLE SUSPENSION, 1 MG/ML AND VIGABATRIN INDUCTION THERAPY V: 2.4; 11.20.2018


Protocol #17-0222, No Longer Enrolling: 3/15/2022
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03347526

Twenty-One-Gene Recurrence Score Assay in CHEK2-Associated Versus Sporadic Breast Cancers: A Case-Control Study


Protocol #17-0763, No Longer Enrolling: 11/26/2019
Locations: University of Colorado Hospital

Rituximab plus Cyclophosphamide followed by Belimumab For the Treatment of Lupus Nephritis


Protocol #16-0604, No Longer Enrolling: 10/1/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02260934

Genotype Phenotype Discordance in Polypharmacy Patients


Protocol #14-0381, No Longer Enrolling: 10/9/2020
Locations: University of Colorado Hospital

Developing biomarkers of acute alcohol exposure


Protocol #15-1799, No Longer Enrolling: 12/28/2019
Locations: CTRC-adult, University of Colorado Hospital

Effect of Urinary Alkalinization on Urine Uric Acid Precipitation and Crystallization in Adults with Type 1 Diabetes


Protocol #15-0541, No Longer Enrolling: 12/27/2019
Locations: CTRC-adult, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02502071

Vascular mechanisms for the effects of loss of ovarian hormone function on cognition in women


Protocol #14-0193, No Longer Enrolling: 5/20/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02122198

Effects of acetate, alcohol, and gut microbiome on brain function


Protocol #15-0933, No Longer Enrolling: 5/22/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02542150

Comparative Effectiveness Between Long Term Fingolimod versus Glatiramer Acetate On Brain Atrophy Rates, Cognition and Patient Reported Outcomes in Patients with Multiple Sclerosis


Protocol #14-0774, No Longer Enrolling: 5/20/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02307877

HepQuant (HQ)-SHUNT Correlates of Hepatic Venous Pressure Gradient (HVPG) Testing


Protocol #15-0520, No Longer Enrolling: 4/6/2021
Locations: University of Colorado Hospital

Outcomes of surgical and medical management of craniopharyngiomas


Protocol #17-0365, No Longer Enrolling: 10/22/2019
Locations: University of Colorado Hospital

Effects of Sofosbuvir/Ledipasvir Treatment on the Pharmacokinetcs and Renal Safety of Tenofovir


Protocol #15-0123, No Longer Enrolling: 5/20/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02588287

Bone and Vascular Health in Postmenopausal Women with Type 1 diabetes


Protocol #15-1854, No Longer Enrolling: 9/18/2020
Locations: University of Colorado Hospital

High Dose Oral Steroids in Sudden Sensorineural Hearing loss


Protocol #16-2342, No Longer Enrolling: 4/22/2023
Locations: Colorado Research Center, Department Specific Free Standing Clinic, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03255473

Therapeutic modulation of the intestinal creatine kinase system in inflammatory bowel disease (IBD)

Specific Aim 1: Determine whether creatine supplementation induces improvement in the endoscopic assessment of mucosal inflammation in ulcerative colitis (UC). Specific Aim 2: Evaluate the feasibility of the current study protocol. Specific Aim 3: Assess the impact of creatine supplementation on intestinal epithelial barrier function and the intestinal microbiome.
Protocol #13-3054, No Longer Enrolling: 3/16/2023
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02463305

A retrospective study of Inotuzumab Ozogamicin in children with relapsed or refractory acute lymphoblastic leukemia (ALL)


Protocol #17-0666, No Longer Enrolling: 11/7/2019
Locations: Childrens Hospital Colorado

Post Market Clinical Follow Up Evaluating the Infinity Deep Brain Stimulation Implantable Pulse Generator System


Protocol #17-0722, No Longer Enrolling: 10/1/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02989610

Targeted strength training to improve gait in people with multiple sclerosis: a feasibility study


Protocol #16-2610, No Longer Enrolling: 5/3/2023
Locations: Colorado Research Center, University of Colorado Hospital

A Dose Frequency Optimization, Phase IIIB/IV Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects with Advanced or Metastatic Non-small Cell Lung Cancer who Received 4 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks


Protocol #16-6086, No Longer Enrolling: 7/28/2021
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital
More information available at ClinicalTrials.gov: NCT02713867

Zoster Eye Disease Study (ZEDS): A multi-center, randomized, double-masked, placebo-controlled clinical trial of suppressive valacyclovir for one year in immunocompetent study participants with an episode of dendriform epithelial keratitis, stromal keratitis, endothelial keratitis, and/or iritis due to Herpes Zoster Ophthalmicus (HZO) in the year prior to enrollment

This study is looking to see if treatment with 12 months of daily valacyclovir medication reduces the development of certain types of new or worsening eye disease; specifically, infection on the surface of the front of the eye (cornea), inflammation of the cornea, or inflammation inside the front of the eye. We also hope to find out if this treatment reduces ongoing pain after the shingles infection goes away. In addition, we want to find out if the effects of valacyclovir treatment last during the six months after treatment is finished.
Protocol #17-0585, No Longer Enrolling: 8/26/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03134196

A Pilot Randomized Double-Blind Placebo-Controlled Phase 2 Trial of the Safety, Efficacy, and Long-Term Tolerability of GM-CSF (Leukine?) in the Treatment of Alzheimer's Disease


Protocol #17-0215, No Longer Enrolling: 10/1/2019
Locations: University of Colorado Hospital

Home or Away From Home: Comparing patient and caregiver reported quality of life and other patient-centered outcomes for inpatient versus outpatient management of neutropenia in children with AML or MDS receiving standard intensive AML frontline chemotherapy


Protocol #17-0812, No Longer Enrolling: 6/24/2020
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02777021

Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-936558 (nivolumab) in Participants with Severe Sepsis or Septic Shock.


Protocol #17-6150, No Longer Enrolling: 5/20/2020
Locations: Memorial Hospital Central
More information available at ClinicalTrials.gov: NCT02960854

A Prospective, Multicenter Registry for Premature Newborns with Severe Pulmonary Hypertension


Protocol #16-2491, No Longer Enrolling: 5/3/2023
Locations: University of Colorado Hospital

Sleep Disordered Breathing Accounts for Abnormal Glycemic Profiles in Pregnant Women: The Sleep in Pregnancy (SiP) Study


Protocol #16-2568, No Longer Enrolling: 5/28/2021
Locations: University of Colorado Hospital

Cross-Cultural Use of Performance-Based Functional Assessment in Alzheimer's Disease


Protocol #16-1954, No Longer Enrolling: 5/28/2021
Locations: University of Colorado Hospital

Retrospective study evaluating the outcomes and clinical characteristics of patients with grade 3A follicular lymphoma


Protocol #17-1041, No Longer Enrolling: 11/7/2019
Locations: University of Colorado Hospital

Assessment of Stakeholder Perspectives of the Clinical Utility of Pharmacogenomics in Solid Organ Transplantation


Protocol #17-1173, No Longer Enrolling: 1/30/2024
Locations: University of Colorado Hospital

Retrospective study assessing radiographic parameters to predict the likelihood of relapse in patients with aggressive non-hodgkin and hodgkin lymphoma


Protocol #17-0784, No Longer Enrolling: 10/5/2019
Locations: University of Colorado Hospital

Registry of Angiovac Procedures In Detail Outcomes Database

The primary objective of this registry is to determine the procedure related mortality associated with the use of the Angiovac device. This is a FDA approved device, being used in clinical practice for the removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours.
Protocol #15-1608, No Longer Enrolling: 11/6/2020
Locations: University of Colorado Hospital

Brain metastases from endometrial cancer: a case series and literature review


Protocol #17-1222, No Longer Enrolling: 11/26/2019
Locations: University of Colorado Hospital

PHASE 2, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, DOSE-RANGING, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF CK-2127107 IN PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSIS (ALS)


Protocol #17-0734, No Longer Enrolling: 10/1/2019
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03160898

Damage to the temporal and marginal mandibular branches of the facial nerve in Mohs Micrographic Surgery


Protocol #17-1307, No Longer Enrolling: 11/26/2019
Locations: University of Colorado Hospital

A comparison of intranasal midazolam and Nitrous Oxide (N2O) minimal sedation for minor procedures in a pediatric emergency department


Protocol #16-1909, No Longer Enrolling: 12/2/2021

Assessment of neuroimaging measurements in predicting post-operative outcomes following resective surgery for brain tumors


Protocol #17-1136, No Longer Enrolling: 10/18/2019
Locations: University of Colorado Hospital

Genetic Predictors of QT Prolongation with Anti-arrhythmic Medication (AADGEN)


Protocol #16-2675, No Longer Enrolling: 9/6/2023
Locations: University of Colorado Hospital

Cesarean Wound Closure in Women with BMI 40 or Greater: A Randomized Controlled Trial Comparing Subcuticular Suture to Surgical Staples C: 4.0; 04/24/2017


Protocol #16-1748, No Longer Enrolling: 5/2/2020
Locations: University of Colorado Hospital

Early feeding following percutaneous gastrostomy tube placement


Protocol #16-1074, No Longer Enrolling: 11/14/2019
Locations: University of Colorado Hospital

The Incidence and Risk of Thrombocytopenia Following Peripheral Blood Stem Cell Donation in Adult, Related Allogeneic Donors.


Protocol #17-1336, No Longer Enrolling: 11/28/2019
Locations: University of Colorado Hospital

Reduced Intensity Conditioning for Haploidentical Bone Marrow Transplantation in Patients with Symptomatic Sickle Cell Disease


Protocol #17-1363, No Longer Enrolling: 11/3/2022
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03263559

Multi-institutional retrospective exploratory chart review to assess the response rate to a class of drugs called poly ADP ribose polymerase inhibitors (PARPi) in patients with ovarian cancer who have previously been treated with PARPi


Protocol #17-0850, No Longer Enrolling: 11/1/2019
Locations: University of Colorado Hospital

The Risk of Long-Term Vascular Dysfunction in Women with a History of Pregnancy-Induced Hypertension


Protocol #16-2581, No Longer Enrolling: 12/2/2022
Locations: Outpatient CTRC, University of Colorado Hospital

Real-Time Sleep Stage Classification with Unobstrustive Bio-potential Recording System


Protocol #16-0328, No Longer Enrolling: 6/15/2021
Locations: Childrens Hospital Colorado, CTRC Inpatient, University of Colorado Hospital

Lipoprotein lipase enzyme activity assay validation and clinical assessment


Protocol #15-1412, No Longer Enrolling: 1/6/2021
Locations: University of Colorado Hospital

FUNCTIONAL ANALYSIS OF COMPLEMENT RECEPTOR 2 AS A LUPUS SUSCEPTIBILITY GENE


Protocol #06-0501, No Longer Enrolling: 6/3/2023
Locations: Outpatient CTRC, University of Colorado Hospital

Retrospective review of radiation oncology clinical, imaging, radiation, and outcomes data


Protocol #17-1004, No Longer Enrolling: 11/7/2019
Locations: University of Colorado Hospital

Open-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) V: 5.0; 13Mar2018


Protocol #17-1267, No Longer Enrolling: 11/2/2019
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02562235

A Retrospective Study of Prolaris for the Prediction of Progression in Men Treated with Modern External Beam Radiation Therapy for Prostate Cancer


Protocol #16-2414, No Longer Enrolling: 10/22/2019
Locations: University of Colorado Hospital

A cluster randomized trial of a home-based intervention to increase uptake of postpartum contraceptives and its effect on short-interval pregnancy rates in a postpartum population of rural Guatemalan women


Protocol #17-1314, No Longer Enrolling: 9/10/2021

Identification of patients at high risk for readmission after a COPD exacerbation


Protocol #17-0245, No Longer Enrolling: 8/29/2023
Locations: University of Colorado Hospital

Virtual and Augmented Reality Study


Protocol #17-6191, No Longer Enrolling: 3/3/2021
Locations: Medical Center of the Rockies

Lifeboard Software Functionality Study

Accuracy of the software will be evaluated through case review. The cases entered into the Lifeboard software will be compared to the paper trauma flow sheet. Research staff will be comparing what is entered into the software on the tablet against the trauma flow sheet for each case.
Protocol #UCH14-1326, No Longer Enrolling: 1/6/2021
Locations: Medical Center of the Rockies

S1007: A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less. RxPONDER: A Clinical Trial Rx for Positive Node, Endocrine Responsive Breast Cancer


Protocol #UCH11-0510, No Longer Enrolling: 10/1/2019
Locations: Memorial Hospital Central

S0931: EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study


Protocol #UCH11-0716, No Longer Enrolling: 10/1/2019
Locations: Memorial Hospital Central

An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)


Protocol #UCH14-0104, No Longer Enrolling: 5/19/2020
Locations: Memorial Hospital Central

Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women with Endocrine Responsive Breast Cancer


Protocol #UCH07-0207, No Longer Enrolling: 10/1/2019
Locations: Memorial Hospital Central

A PHASE III TRIAL OF 6 VERSUS 12 TREATMENTS OF ADJUVANT FOLFOX PLUS CELECOXIB OR PLACEBO FOR PATIENTS WITH RESECTED STAGE III COLON CANCER


Protocol #UCH10-0821, No Longer Enrolling: 10/1/2019
Locations: Memorial Hospital Central

A PHASE 3 OPEN-LABEL RANDOMIZED STUDY TO COMPARE THE EFFICACY AND SAFETY OF RITUXIMAB PLUS LENALIDOMIDE (CC-5013) VERSUS RITUXIMAB PLUS CHEMOTHERAPY FOLLOWED BY RITUXIMAB IN SUBJECTS WITH PREVIOUSLY UNTREATED FOLLICULAR LYMPHOMA


Protocol #UCH11-1023, No Longer Enrolling: 10/1/2019
Locations: Memorial Hospital Central

E1505: A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (!Y 4 cm) - IIIA Non-Small Cell Lung Cancer (NSCLC)


Protocol #UCH09-0308, No Longer Enrolling: 10/1/2019
Locations: Memorial Hospital Central

E1609 A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon a-2b for Resected High-Risk Melanoma


Protocol #UCH11-0715, No Longer Enrolling: 10/1/2019
Locations: Memorial Hospital Central

Retrospective review of clinical and dosimetric data for breast cancer patients receiving radiotherapy


Protocol #17-0380, No Longer Enrolling: 11/1/2019
Locations: Memorial Hospital Central, Memorial Hospital North

E5202: A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers


Protocol #UCH09-1018, No Longer Enrolling: 10/1/2019
Locations: Memorial Hospital Central

Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment: The TAILORx Trial


Protocol #UCH06-0629, No Longer Enrolling: 10/1/2019
Locations: Memorial Hospital Central

S0221: Phase III Trial of Continuous Schedule AC + G Vs. Q 2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High- Risk Node Negative Breast Cancer


Protocol #UCH07-0623, No Longer Enrolling: 10/1/2019
Locations: Memorial Hospital Central

S0307: Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer


Protocol #UCH06-0730, No Longer Enrolling: 10/1/2019
Locations: Memorial Hospital Central

A Phase 2, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of neurobehavioral disinhibition including aggression, agitation, and irritability in patients with traumatic brain injury (TBI).

Structure: This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study. Duration: Patients will be enrolled in the study for up to 16 weeks, with up to a 4-week screening period and a 12-week treatment period. Study Treatment: The investigational product is AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]), which is titrated over a 2-week period to d6-DM 42.63 mg/Q 4.9 mg (AVP-786-42.63/4.9) twice daily (BID). Control: Placebo capsules appearing identical to study medication will be used as control. Randomization: Eligible patients will be randomized into the study to receive AVP-786 or placebo. Dose Regimen:
Protocol #17-6198, No Longer Enrolling: 3/24/2021
Locations: Medical Center of the Rockies
More information available at ClinicalTrials.gov: NCT03095066

RTOG 0129: A PHASE III TRIAL OF CONCURRENT RADIATION AND CHEMOTHERAPY (FOLLOWED BY SURGERY FOR RESIDUAL PRIMARY/N2-3 NODAL DISEASE) FOR ADVANCED HEAD AND NECK CARCINOMAS


Protocol #UCH02-1026, No Longer Enrolling: 10/1/2019
Locations: Memorial Hospital Central

A Phase 2, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of neurobehavioral disinhibition including aggression, agitation, and irritability in patients with traumatic brain injury (TBI).


Protocol #17-6199, No Longer Enrolling: 5/19/2020
Locations: Memorial Hospital Central
More information available at ClinicalTrials.gov: NCT03095006

GORE? HELEX? Septal Occluder / GORE? Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke or Imaging- Confirmed TIA in Patients with Patent Foramen Ovale (PFO)


Protocol #13-3034, No Longer Enrolling: 4/2/2021
Locations: University of Colorado Hospital

The influence of gonadal hormone suppression on adipocyte lineage and the microbiome

Six month intervention of ovarian hormone supression This research study plans to learn more about the role of female sex hormones on fat and the gut microbiome (or the organisms that are in your digestive tract).
Protocol #17-1869, No Longer Enrolling: 8/19/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03396978

VEIN OF MARSHALL ETHANOL INFUSION FOR PERSISTENT ATRIAL FIBRILLATION


Protocol #16-1551, No Longer Enrolling: 10/1/2019
Locations: University of Colorado Hospital

MONALEESA-3: A randomized double-blind, placebocontrolledstudy of ribociclib in combination withfulvestrant for the treatment of postmenopausal womenwith hormone receptor positive, HER2-negative, advancedbreast cancer who have received no or only one line ofprior endocrine treatment

To compare PFS between ribociclib in combination with fulvestrant to placebo in combination with fulvestrant among postmenopausal women with HR+, HER2-negative advanced breast cancer who received no or only one prior endocrine treatment for advanced disease
Protocol #15-6019, No Longer Enrolling: 1/29/2020
Locations: Greeley Hospital, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital
More information available at ClinicalTrials.gov: NCT02422615

A multicenter, randomized, open-label Phase 2 studyevaluating the safety and efficacy of three differentregimens of oral panobinostat in combination withsubcutaneous bortezomib and oral dexamethasone inpatients with relapsed or relapsed/refractory multiplemyeloma who have been previously exposed to immunomodulatory agents


Protocol #16-6057, No Longer Enrolling: 10/1/2019
Locations: Greeley Hospital, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital

A Phase 3, Randomized Study of Margetuximab PlusChemotherapy vs Trastuzumab Plus Chemotherapy in theTreatment of Patients with HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies and RequireSystemic Treatment


Protocol #15-6038, No Longer Enrolling: 5/3/2022
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital
More information available at ClinicalTrials.gov: NCT02492711

A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries


Protocol #UCH12-1142, No Longer Enrolling: 5/20/2020

Prospective, Randomized, SingLe-Blind, U.S. MuLti-Center Study to EvalUate TreatMent of obstructive SupErficial Femoral Artery or Popliteal LesioNs With A Novel Paclitaxel-CoatEd Percutaneous Angioplasty Balloon


Protocol #UCH13-1272, No Longer Enrolling: 5/20/2020

Evaluation of commercial pharmacogenomic testing in psychiatry medicine.


Protocol #17-2347, No Longer Enrolling: 7/29/2023
Locations: University of Colorado Hospital

Influence of PTSD Symptoms on Chronic Pain Development After Sexual Assault


Protocol #15-6021, No Longer Enrolling: 1/6/2021
Locations: Memorial Hospital Central

A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo versus Carboplatin and Paclitaxel Plus Concurrent Bevacizumab (NSC #704865, IND #7921) Followed by Placebo, versus Carboplatin and Paclitaxel Plus Concurrent and Extended Bevacizumab, in Women with Newly Diagnosed, Previously Untreated, Suboptimal Advanced Stage Epithelial Ovarian and Primary Peritoneal Cancer


Protocol #UCH06-778, No Longer Enrolling: 6/17/2022
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital

A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women with Endocrine Responsive Breast Cancer (SOFT)


Protocol #UCH04-680, No Longer Enrolling: 5/20/2020
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital
More information available at ClinicalTrials.gov: NCT00975676

Prospective Data Collection Study of Intra-operative Radiation Therapy (IORT) For Lumpectomy Cavity Boost Treatment Immediately Following Resection In Patients Receiving Radiation Therapy In The Setting of Breast Conserving Therapy v: 7.1; 12/15/2017


Protocol #UCH11-1101, No Longer Enrolling: 2/19/2022
Locations: Harmony Campus

S0820: A DOUBLE BLIND PLACEBO-CONTROLLED TRIAL OF EFLORNITHINE AND SULINDAC TO PREVENT RECURRENCE OF HIGH RISK ADENOMAS AND SECOND PRIMARY COLORECTAL CANCERS IN PATIENTS WITH STAGE 0-III COLON OR RECTAL CANCER, PHASE III-PREVENTING ADENOMAS OF THE COLON WITH EFLORNITHINE AND SULINDAC (PACES) V: 7/2/18


Protocol #UCH13-1260, No Longer Enrolling: 11/7/2019
Locations: Greeley Hospital, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital

Barriers and facilitators to maternal visits in the NICU and impact of visiting on infant development


Protocol #16-0179, No Longer Enrolling: 5/4/2022
Locations: Childrens Hospital Colorado, Denver Health and Hospital Authority, Poudre Valley Hospital, University of Colorado Hospital

Compassionate use of Lorcaserin in Dravet Syndrome

Compassionate use of Lorcaserin in Dravet Syndrome
Protocol #14-2440, No Longer Enrolling: 10/1/2019
Locations: Childrens Hospital Colorado

Prospective, Observational Trial of Blunt Cerebrovascular Injury Management and Stroke Formation

The primary aim of this study is to determine rates of stroke for BCVI overall and by grade of injury and predictors of BCVI related stroke formation.
Protocol #18-6029, No Longer Enrolling: 4/13/2022
Locations: Medical Center of the Rockies

Can the cervical spine be clinically cleared in awake and alert blunt trauma patients with "distracting injuries"?


Protocol #17-6220, No Longer Enrolling: 5/20/2020
Locations: Memorial Hospital Central

Pulse Reduction on Beta Blocker and Ivabradine Therapy (PROBE-IT)

The goals of this study are (1) to test the hypothesis that HR reduction is an important underlying antecedent for reverse remodeling, and (2) to identify components of the beta1-GSN responsible for reverse remodeling caused by HR reduction using ivabradine, which could allow for better drug targeting. This study will also yield hypothesis-generating data on whether ivabradine might be useful in earlier stage HFrEF patients than the current indication.
Protocol #16-1363, No Longer Enrolling: 5/23/2023
Locations: University of Colorado Hospital

Trauma ICU Prevelance Project (TRIPP study) - an American Association for the Surgery of Trauma Multi-institutional Study


Protocol #18-6038, No Longer Enrolling: 5/20/2020
Locations: Memorial Hospital Central

Narcotic consumption in discectomies: microscopic versus endoscopic

In this study a member of the study team will review consenting patient's medical records at pre-op, spine surgery, recovery, follow up visits at 3 months and 12 months
Protocol #18-0830, No Longer Enrolling: 11/15/2023
Locations: University of Colorado Hospital

Unrelated Donor Transplant versus Immune Therapy in Pediatric Severe Aplastic Anemia (TransIT)


Protocol #18-0524, No Longer Enrolling: 7/31/2021
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02845596

Evaluation of Physiologic Characteristics and Clinical Outcomes of Patients with Cardiac Arrythmias Referred for Treatment in the Cardiac Electrophysiology Section


Protocol #16-0996, No Longer Enrolling: 10/1/2019
Locations: University of Colorado Hospital

The Longitudinal Surveillance Study of the 4-SITE Lead/Header System


Protocol #13-2415, No Longer Enrolling: 5/2/2020

Antiviral Cellular Therapy for Enhancing T-cell Reconstitution Before or After Hematopoietic Stem Cell Transplantation (ACES) PBMTC SUP1701


Protocol #18-0834, No Longer Enrolling: 3/2/2021
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03475212

Compassionate use of Kalydeco-L-M (single patient IND #129,402)


Protocol #15-2421, No Longer Enrolling: 10/1/2019
Locations: Childrens Hospital Colorado

PBTC-050: A Phase I and Surgical Study of Ribociclib and Everolimus (RAD001) in Children with Recurrent or Refractory Malignant Brain Tumors


Protocol #18-0947, No Longer Enrolling: 4/18/2020
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03387020

Assessment of the Current Status and Needs for Residency Training on Physics Plan Reviews


Protocol #18-1073, No Longer Enrolling: 11/28/2019
Locations: University of Colorado Hospital

PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF RELTECIMOD AS COMPARED TO PLACEBO IN ADDITION TO STANDARD OF CARE IN PATIENTS WITH SEPSIS-ASSOCIATED ACUTE KIDNEY INJURY (SA-AKI). 10DEC2017


Protocol #18-1095, No Longer Enrolling: 4/7/2020
Locations: Memorial Hospital Central, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03403751

Prospective, Multi-center, Randomized Controlled Study Comparing Endoscopic Clearance of Non-Complex Biliary Stones Using Fluoroscopy/Radiation-Free Direct Solitary Cholangioscopy (DSC) to Standard of Care Endoscopic Retrograde Cholangiography (ERC)


Protocol #18-1137, No Longer Enrolling: 10/10/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03497806

Major Differences in Treatment and Practice Settings for Patients with Acute Lymphoblastic Leukemia


Protocol #18-1031, No Longer Enrolling: 10/31/2019
Locations: University of Colorado Hospital

A Survey Study Examining Cannabis Use in for Cancer Care in Gynecologic Oncology Patients


Protocol #18-1096, No Longer Enrolling: 10/22/2019
Locations: University of Colorado Hospital

Social Convoy Palliative Care (Convoy-Pal) Mobile Health for Older Adults with Advanced Heart Failure


Protocol #RRR18-0973, No Longer Enrolling: 12/28/2023
Locations: Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital

Imaging Early Ovarian Cancer Study: Multi-Institutional study by Society of Abdominal radiology; Uterine Ovarian Cancer Panel


Protocol #18-1143, No Longer Enrolling: 10/22/2019
Locations: University of Colorado Hospital

A Multicenter Retrospective Review of Pediatric Differentiated Thyroid Cancer


Protocol #18-0795, No Longer Enrolling: 11/1/2019
Locations: Childrens Hospital Colorado, University of Colorado Hospital

Post-operative outcomes for nervus intermedius function following acoustic neuroma resection


Protocol #18-1176, No Longer Enrolling: 10/22/2019
Locations: University of Colorado Hospital

Targeting MCJ/DNAJC15 and the mitochondrial electron transport chain in acute myeloid leukemia


Protocol #18-1227, No Longer Enrolling: 11/28/2019
Locations: University of Colorado Hospital

Endocrinopathies in immunotherapy; A retrospective study to evaluate the incidence, risk factors for and clinical implications of immunotherapy induced hypoglycemia.


Protocol #18-1251, No Longer Enrolling: 11/7/2019
Locations: University of Colorado Hospital

A Prospective Randomized Placebo-Controlled Double Blind Clinical Trial to Evaluate the Safety and Efficacy of CLBS03 (Autologous Ex Vivo Expanded Polyclonal CD4+CD25+CD127lo/-FOXP3+ Regulatory T-cells [Tregs]) in Adolescents with Recent Onset Type 1 Diabetes Mellitus (T1DM) v: 7.0; 17-Jan-2017

Assess the safety and potential efficacy of CLBS03 to modify the T1DM disease course, including preservation of a-cell function and improvements in measures of disease severity, as compared with placebo, in adolescents with recent onset T1DM.
Protocol #16-0905, No Longer Enrolling: 3/23/2022
Locations: Barbara Davis Center, UCD Barbara Davis Center

Screening and Surveillance in PCC/PGL Susceptibility Gene Mutation Carriers


Protocol #18-1240, No Longer Enrolling: 11/28/2019
Locations: Childrens Hospital Colorado, University of Colorado Hospital

Second opinion review of outside breast imaging: an analysis of the frequency that additional testing is recommended and radiology/pathology outcomes


Protocol #18-1123, No Longer Enrolling: 11/28/2019
Locations: University of Colorado Hospital

Optimizing delivery of tumor molecular profile information


Protocol #18-1084, No Longer Enrolling: 11/28/2019
Locations: University of Colorado Hospital

A comparison of the immunogenicity and descriptive safety of a live attenuated herpes zoster vaccine and the GSK herpes zoster recombinant HZ/su candidate vaccine in 50-59 year old and 70-85 year old vaccine recipients.


Protocol #13-3192, No Longer Enrolling: 9/10/2021
Locations: Adult Infectious Disease Clinical Trials Center
More information available at ClinicalTrials.gov: NCT02114333

Post-operative reconstruction techniques after translabyrinthine craniotomy: comparison of autologous cranioplasty versus cement reconstruction on functional outcomes and quality of life


Protocol #18-1177, No Longer Enrolling: 10/22/2019
Locations: University of Colorado Hospital

Safety and Efficacy of Immune Checkpoint Inhibitors in Renal and Bladder Cancer Patients with Pre-existing Autoimmune Disorders (Retrospective Study)


Protocol #18-2184, No Longer Enrolling: 10/31/2019
Locations: Lone Tree Medical Center, University of Colorado Hospital

A Humanitarian Device Exemption Treatment Protocol of TheraSphere for Treatment of Unresectable Primary or Secondary Liver Neoplasia


Protocol #07-0084, No Longer Enrolling: 10/22/2019
Locations: University of Colorado Hospital

Risk factors for molecular subtypes of NHL - a prospective evaluation


Protocol #17-0640, No Longer Enrolling: 10/18/2019
Locations: University of Colorado Hospital

Glioma Longitudinal Analysis Consortium


Protocol #18-2263, No Longer Enrolling: 10/22/2019
Locations: University of Colorado Hospital

Efficacy of clofarabine with cytarabine and granulocyte colony-stimulating factor for relapsed and refractory acute myeloid leukemia: a single-center experience


Protocol #18-2186, No Longer Enrolling: 11/28/2019
Locations: University of Colorado Hospital

Assessment of potential predicative and prognostic factors in patients with solid tumors receiving single agent check point inhibitor


Protocol #18-2272, No Longer Enrolling: 11/28/2019
Locations: University of Colorado Hospital

EsVan Infection Risk Prediction Model in Non-Neutropenic Pediatric Oncology Patients


Protocol #18-2257, No Longer Enrolling: 11/28/2019
Locations: Childrens Hospital Colorado

Harnessing the Principles of Visual Perceptual Learning for Training Observers to Interpret Mammography


Protocol #18-2077, No Longer Enrolling: 11/28/2019
Locations: University of Colorado Hospital

Addressing Urban Rural Disparities in Cancer: The Case for Registry Expansion


Protocol #18-2442, No Longer Enrolling: 11/28/2019
Locations: University of Colorado Cancer Center

Laboratory-Based Investigations of Primary Leukemia and Myelodysplastic Syndrome Samples from the Hematologic Tissue Bank


Protocol #18-2461, No Longer Enrolling: 11/28/2019
Locations: University of Colorado Hospital

Ultrarapid Culture Independent Identification and Antibiotic Suspectibility Testing of High-Priority Carbapenem Resistant Enterobacteriaceae Directly from Blood and Urine in Patients with Suspected Bacteremia V: 02 Feb 2017


Protocol #16-0086, No Longer Enrolling: 9/7/2023
Locations: Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital

A double-blind randomized placebo-controlled trial assessing the effects of inclisiran on clinical outcomes among people with atherosclerotic cardiovascular disease

About 15,000 people will take part in this study. Half will get inclisiran injections and half will get dummy placebo) injections. A placebo is a substance that looks like a drug, but has no drug in it. This form will refer to both inclisiran and placebo as “study drug.” Which study drug you get is decided by chance and you will not know which study drug you are given. Joining the study involves 3 clinic visits in the first 5 months and then a visit every 6- months. At each visit a trained researcher will ask some questions about your health, take a blood sample, and give you an injection into your abdomen (tummy). It is expected that about 1 in 20 people administered inclisiran may notice some redness or soreness where the injection is given, but no other side effects have been found. However, at this stage, scientists cannot rule out the possibility of other side effects. You are asked to stay in the study for about 5 years.
Protocol #18-6511, No Longer Enrolling: 8/16/2023
Locations: Memorial Hospital Central
More information available at ClinicalTrials.gov: NCT03705234

Dissecting the Role of Inflammation in Smoking and Aging Associated Lung Cancers


Protocol #18-2584, No Longer Enrolling: 11/28/2019
Locations: Rocky Mountain Regional VA Medical Center

Enhancing Efficacy of Checkpoint Inhibitors through VEGF Blockade in Sarcomas


Protocol #18-2499, No Longer Enrolling: 10/28/2019
Locations: University of Colorado Hospital

Nervus intermedius outcomes after vestibular schwannoma surgery


Protocol #18-2590, No Longer Enrolling: 11/28/2019
Locations: University of Colorado Hospital

Understanding Barriers to Enrollment in Clinical Trials at the University of Colorado Cancer Center


Protocol #18-2684, No Longer Enrolling: 8/4/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT00000000

Evaluation of the treatment of coagulase negative staphylococci identified in blood cultures of outpatient stem cell transplant patients


Protocol #18-2701, No Longer Enrolling: 11/28/2019
Locations: University of Colorado Hospital

An Exploratory Investigation of the Impact of the Assistive Technology Partners Product Testing Laboratory


Protocol #11-0674, No Longer Enrolling: 10/9/2021
Locations: Memorial Hospital Central, Memorial Hospital North

Use of a Pharmacy Managed Empiric Continuous Infusion Vancomycin Protocol in Pediatrics


Protocol #18-6128, No Longer Enrolling: 5/20/2020
Locations: Memorial Hospital Central

Community Cancer Needs Evaluation Project


Protocol #18-2699, No Longer Enrolling: 10/22/2019
Locations: University of Colorado Hospital

Analyzing variations in pre-operative imaging for patients with newly diagnosed breast cancer using the SEER-Medicare database


Protocol #18-2828, No Longer Enrolling: 11/28/2019
Locations: University of Colorado Hospital

NCCN Best Practices Psychologist Staffing Metrics Survey


Protocol #18-2840, No Longer Enrolling: 11/19/2019
Locations: University of Colorado Hospital

New Graduate Nurse Orientation Using a Staged, Task-Layered Strategy: Implications for Length of Orientation and Self-Reported Confidence


Protocol #18-6119, No Longer Enrolling: 12/8/2023
Locations: Medical Center of the Rockies, Poudre Valley Hospital

Caretaker Wireless Vital Sign Monitor Applied in the Field and Transitioned into the Emergency Department: A Quality Initiative Project to Determine the Efficacy of the Caretaker Device Compared to Standard Vital Sign Recordings

To test wireless vital sign monitor in the field and determine feasibility.
Protocol #18-6102, No Longer Enrolling: 3/5/2021
Locations: Medical Center of the Rockies

Blood Transfusion During Hepatectomy


Protocol #18-2887, No Longer Enrolling: 10/30/2019
Locations: University of Colorado Hospital

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Non-Cirrhotic Subjects with Primary Sclerosing Cholangitis


Protocol #19-0444, No Longer Enrolling: 7/19/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03742973

A Phase 3, Randomized, Double-Blind, Multinational, Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab (PRV-031), a Humanized, FcR Non-Binding, anti-CD3 Monoclonal Antibody, in Children and Adolescents with Newly Diagnosed Type 1 Diabetes (T1D)


Protocol #19-0489, No Longer Enrolling: 4/19/2022
Locations: Barbara Davis Center, Outpatient CTRC, UCD Barbara Davis Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03875729

Clinical data paired with omics profiling of leukemic stem cells in patients with AML to predict the likelihood of treatment failure with Venetoclax plus azacytidine and direct patients to optimal therapy


Protocol #19-0522, No Longer Enrolling: 10/23/2019
Locations: University of Colorado Hospital

A Comprehensive and Collaborative Review of the Use of Whole Blood at Trauma Centers in the United States

Compare Whole Blood vs Component Therapy
Protocol #19-6047, No Longer Enrolling: 1/12/2023
Locations: Medical Center of the Rockies, Poudre Valley Hospital

The Perelman Study of IntraUterine Growth Restriction


Protocol #14-1360, No Longer Enrolling: 10/9/2021
Locations: Childrens Hospital Colorado, University of Colorado Hospital

Patient distress at the time of breast cancer diagnosis


Protocol #19-0693, No Longer Enrolling: 11/1/2019
Locations: University of Colorado Hospital

Integration of Specialty Palliative Care in a Phase I Ovarian Cancer Population


Protocol #19-0653, No Longer Enrolling: 10/28/2019
Locations: University of Colorado Hospital

Outcomes Research for Patients Undergoing Treatment for Cutaneous Squamous Cell Carcinoma at the University of Colorado


Protocol #19-0950, No Longer Enrolling: 11/16/2019
Locations: University of Colorado Hospital

Midostaurin (Rydapt), liquid formulation, emergency sIND


Protocol #19-6064, No Longer Enrolling: 10/1/2019
Locations: Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital

Retrospective Review of Cyclophosphamide in the Treatment of Prostate Cancer


Protocol #19-0973, No Longer Enrolling: 11/1/2019
Locations: University of Colorado Hospital

Reliability of Fluorescein-assisted Stereotactic Brain Biopsies in Predicting Conclusive Tissue Diagnosis


Protocol #19-1028, No Longer Enrolling: 12/28/2019
Locations: University of Colorado Hospital

Retrospective analysis of radiotherapy plus concomitant temozolomide in meningioma treatment


Protocol #19-1089, No Longer Enrolling: 11/7/2019
Locations: University of Colorado Hospital

TOPP-2 registry Tacking Outcomes and Practice in Pediatric Pulmonary Hypertension V: 27 July 2018


Protocol #15-0693, No Longer Enrolling: 1/24/2023
Locations: Childrens Hospital Colorado

Retrospective study of the prevalence and outcomesvof children with cancer at the Jose Renan Esquivel Hospital (HJRE) and Hospital Materno Infantil Jose Domingo Obadia (HMIJDO) of Panama City and Chiriqui, Panama


Protocol #19-1136, No Longer Enrolling: 11/7/2019

Non-operative management of suspected Calvarial Langerhans Cell Histiocytosis V: 20March2017


Protocol #13-2571, No Longer Enrolling: 10/1/2019
Locations: Childrens Hospital Colorado

Posterior Fossa Decompression with or without Duraplasty for Chiari type I Malformation with Syringomyelia V: 5; March 20, 2018


Protocol #16-1998, No Longer Enrolling: 7/21/2023
Locations: Childrens Hospital Colorado

Multi-Institutional Validation of Trauma Specific Frailty Index

To test the predictive ability of the Trauma Sepcific Frailty Index.
Protocol #19-6084, No Longer Enrolling: 3/22/2022
Locations: Medical Center of the Rockies

Prevalence of malignancy in incidentally detected homogeneous renal masses measuring 21-39 Hounsfield units on portal venous-phase CT: A multi-institutional retrospective cohort study


Protocol #19-1306, No Longer Enrolling: 10/22/2019
Locations: University of Colorado Hospital

Outcomes of Oligometastatic Renal Cell Carcinoma to Pancreas


Protocol #19-1465, No Longer Enrolling: 10/31/2019
Locations: University of Colorado Hospital

Single Patient IND for sEphB4-HSA, IND#144870


Protocol #19-1388, No Longer Enrolling: 10/1/2019
Locations: University of Colorado Hospital

Apoyo con Cari?o (Support through Caring): Improving Palliative Care Outcomes for Latinos with Advanced Medical Illness V: 03/20/19


Protocol #16-1270, No Longer Enrolling: 12/3/2022
Locations: Denver Health and Hospital Authority, University of Colorado Hospital

Intra articular injections with platelet rich plasma in patients with Juvenile Osteochondritis Dissecans of the knee: Does it Help? A clinical and MR study


Protocol #13-2797, No Longer Enrolling: 10/4/2019
Locations: Childrens Hospital Colorado

Single Patient IND for idebenone, IND# 145007, NSL


Protocol #19-1495, No Longer Enrolling: 10/1/2019
Locations: University of Colorado Hospital

Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults with ADPKD


Protocol #15-0902, No Longer Enrolling: 7/8/2021
Locations: Childrens Hospital Colorado, Colorado Research Center

International Fetal Cardiac Intervention Registry


Protocol #14-0343, No Longer Enrolling: 10/5/2023
Locations: Childrens Hospital Colorado

Prospective, observational, multi-center cohort study of venous thromboembolism outcomes in thrombocytopenic cancer patients (TROVE Study)


Protocol #18-1461, No Longer Enrolling: 1/6/2021
Locations: University of Colorado Hospital

A retrospective review of locally advanced pancreatic adenocarcinoma outcomes within the University of Colorado Health system by neoadjuvant chemotherapy dosing and tumor marker levels


Protocol #17-1414, No Longer Enrolling: 11/7/2019
Locations: Colorado Research Center

Molecular characterization and treatment exploration in hormone therapy-resistant breast cancer


Protocol #17-1411, No Longer Enrolling: 10/22/2019
Locations: University of Colorado Hospital

Retrospective analysis of Invasive Mucormycosis in patients with hematologic malignancies and hematopoietic stem cell transplant recipients in the era of new anti-fungals


Protocol #17-1591, No Longer Enrolling: 11/7/2019
Locations: University of Colorado Hospital

Extracolonic Cancer Risks in Monoallelic and Biallelic MutYH Carriers


Protocol #17-1378, No Longer Enrolling: 11/28/2019
Locations: University of Colorado Hospital

Avascular Necrosis Secondary to the Treatment of Leukemia in the Pediatric Population


Protocol #17-1401, No Longer Enrolling: 11/28/2019
Locations: Childrens Hospital Colorado

External Reproducibility Study of SK005 PD-L1 IHC 28-8 pharmDx on Gastric Gastroesophageal Junction Specimens


Protocol #17-1798, No Longer Enrolling: 11/28/2019
Locations: University of Colorado Hospital

Bone Morphogenetic Proteins in Bone Metastases


Protocol #17-1733, No Longer Enrolling: 11/28/2019
Locations: University of Colorado Hospital

A retrospective review of dose adjustments for 5-fluorouracil based regimens at the University of Colorado Cancer Center


Protocol #17-1942, No Longer Enrolling: 10/19/2019
Locations: University of Colorado Hospital

Ovarian Cancer: An interdisciplinary approach for the identification of novel therapeutic targets.


Protocol #17-1794, No Longer Enrolling: 11/28/2019
Locations: University of Colorado Hospital

Ovarian Cancer: An interdisciplinary approach for the identification of novel diagnostic biomarkers and therapeutic targets


Protocol #18-0119, No Longer Enrolling: 11/28/2019
Locations: University of Colorado Hospital

Redefining natural history of smoldering multiple myeloma and developing a new risk stratification system


Protocol #17-1753, No Longer Enrolling: 10/18/2019
Locations: University of Colorado Hospital

Retrospective study assessing the utility of cardiooncology follow up post completion of chemotherapy on identifying cardiotoxicity risk and short-term incidence and pattern of cardiotoxicity


Protocol #17-1763, No Longer Enrolling: 10/18/2019
Locations: University of Colorado Hospital

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of Evaluating the Safety and Efficacy of Intravenous Delivery of Allogeneic Cardiosphere-Derived Cells in Subjects with Duchenne Muscular Dystrophy (HOPE-2) V: 4.0 / 17Jan2019


Protocol #18-0079, No Longer Enrolling: 10/1/2019
Locations: Childrens Hospital Colorado

Preoperative ligation of ethmoid arteries in resection of anterior fossa meningiomas


Protocol #17-2115, No Longer Enrolling: 10/22/2019
Locations: University of Colorado Hospital

Post-operative imaging after pituitary tumor resection


Protocol #17-2116, No Longer Enrolling: 10/22/2019
Locations: University of Colorado Hospital

Development and Dissemination of KiNet: An Imaging Informatics Tool for Ki67 Counting in Neuroendocrine Tumor


Protocol #17-2167, No Longer Enrolling: 11/28/2019
Locations: University of Colorado Hospital

Disorders of Sex Development and Malignant Germ Cell Tumors


Protocol #17-2142, No Longer Enrolling: 11/28/2019
Locations: Childrens Hospital Colorado

Retrospective Analysis of Patients with Small-Cell Lung Cancer (SCLC) Managed with Radiosurgery for Brain Metastases


Protocol #18-0080, No Longer Enrolling: 11/7/2019
Locations: University of Colorado Hospital

PET Parameters in Differentiating Low-Grade versus Grade 3A Follicular Lymphoma


Protocol #18-0023, No Longer Enrolling: 11/14/2019
Locations: University of Colorado Hospital

Investigating alterations in molecular pathways in human epithelial ovarian cancer tumors


Protocol #17-7788, No Longer Enrolling: 11/28/2019
Locations: University of Colorado Hospital

Retrospective Analysis of Patients treated with Radiosurgery for Brain Metastases from ALK Rearranged and EGFR Mutated NSCLC


Protocol #18-0081, No Longer Enrolling: 11/7/2019
Locations: University of Colorado Hospital

Harnessing principles of visual perceptual learning to improve breast cancer detection by developing evidence based training techniques


Protocol #18-0094, No Longer Enrolling: 11/28/2019
Locations: University of Colorado Hospital

Machine Learning Technology as a Diagnostic Tool in Medulloblastoma and Ependymoma


Protocol #18-0201, No Longer Enrolling: 11/28/2019
Locations: Childrens Hospital Colorado, University of Colorado Hospital

Retrospective study to establish clinical or imaging characteristics of bone and soft tissue tumor that may affect outcomes following percutaneous ablation


Protocol #18-0357, No Longer Enrolling: 11/7/2019
Locations: University of Colorado Hospital

Intraoperative sodium fluorescein for tissue biopsy and resection of spinal cord lesions


Protocol #18-0335, No Longer Enrolling: 11/28/2019
Locations: University of Colorado Hospital

Treatment of Advanced Hepatocellular Carcinoma With DEB-TACE


Protocol #18-0409, No Longer Enrolling: 10/22/2019
Locations: University of Colorado Hospital

The impact of utilizing radiation therapy planning CT on FDG PET/CT interpretation


Protocol #18-0515, No Longer Enrolling: 11/28/2019
Locations: University of Colorado Hospital

The Effect of Cervical Cancer Screening on the Incidence Rate of Invasive Cervical Carcinoma in HIV-positive Women in Lusaka, Zambia


Protocol #18-0528, No Longer Enrolling: 11/28/2019
Locations: University of Colorado Hospital

Racial disparities in cancer treatment, patient-experiences with medical care, patient-reported outcomes, and mortality among cancer patient


Protocol #18-0597, No Longer Enrolling: 10/18/2019
Locations: University of Colorado Hospital, University of Southern California

Safety of Dalteparin Antithrombotic Therapy in Patients with Cancer-Associated Thromboembolism


Protocol #18-0636, No Longer Enrolling: 10/31/2019
Locations: University of Colorado Hospital

Koebnerizing squamous cell carcinoma treated with intralesional 5-fluouracil


Protocol #18-0596, No Longer Enrolling: 11/28/2019
Locations: University of Colorado Hospital

Risk Factors for Acquired Immune Deficiency Syndrome-Associated Kaposi sarcoma AIDS-KS) Mortality among Zimbabwean Adults (A sub-study of Strategies to Improve Kaposi Sarcoma (KS) Outcomes in Zimbabwe (SIKO))


Protocol #18-0749, No Longer Enrolling: 11/28/2019

Predictors of childhood obesity in cancer survivors


Protocol #18-0263, No Longer Enrolling: 11/28/2019
Locations: University of Colorado Hospital

Comparison of Tomosynthesis and Digital Mammography for Breast Cancer Screening


Protocol #18-0717, No Longer Enrolling: 11/28/2019
Locations: University of Colorado Hospital

Effect of Rotational Angiography on Radiation Exposure During Percutaneous Liver Directed Therapy in Interventional Radiology


Protocol #18-0726, No Longer Enrolling: 11/28/2019
Locations: University of Colorado Hospital

A Retrospective Record Review of Mobilization Strategies with and without Plerixafor for Autologous Stem Cell Transplant in Patients with Multiple Myeloma


Protocol #18-0748, No Longer Enrolling: 10/18/2019
Locations: University of Colorado Hospital

Lynch Syndrome: Further Defining the Pediatric Spectrum


Protocol #18-0598, No Longer Enrolling: 11/28/2019
Locations: Childrens Hospital Colorado

Evaluation of recurrent breast cancer in women diagnosed with DCIS treated only with mastectomy


Protocol #18-0776, No Longer Enrolling: 10/25/2019
Locations: University of Colorado Hospital

Targeted therapy for pediatric low-grade glioma and plexiform neurofibromas with trametinib


Protocol #18-1383, No Longer Enrolling: 11/28/2019
Locations: Childrens Hospital Colorado

Computational Phenotyping of Cancer Antecedents and Outcomes


Protocol #18-0848, No Longer Enrolling: 11/28/2019
Locations: University of Colorado Hospital

Practice patterns and incidence of adenovirus infections in hematopoietic cell transplant in the United States: AdVance US


Protocol #18-1420, No Longer Enrolling: 11/28/2019
Locations: Childrens Hospital Colorado

Retrospective study to assess the effect of androgen deprivation therapy on imaging findings in the prostate on multiparametric prostate MRI


Protocol #18-1278, No Longer Enrolling: 10/22/2019
Locations: University of Colorado Hospital

Retrospective study to assess the variation of number of cases ordered and performed through out the year of testicular ultrasounds


Protocol #18-1277, No Longer Enrolling: 11/7/2019
Locations: University of Colorado Hospital

Liposomal Doxorubicin MUE: An evaluation of ejection fraction assessment in breast and ovarian cancer patients receiving liposomal doxorubicin at the University of Colorado Hospital and Cancer Center


Protocol #18-1453, No Longer Enrolling: 11/28/2019
Locations: University of Colorado Hospital

Breast Cancer Brain Metastases Localization to Regions with Increased Estrogen Production


Protocol #18-1720, No Longer Enrolling: 10/22/2019
Locations: University of Colorado Hospital

Estimating Community-Level HPV Vaccine Coverage for Better Targeted Vaccination Uptake Interventions


Protocol #18-1732, No Longer Enrolling: 10/22/2019
Locations: University of Colorado Hospital

Surgically Treated Biphenotypic (Hepatobilliary) Primary Liver Carcinomas A Multicenter Review


Protocol #18-1708, No Longer Enrolling: 11/28/2019
Locations: University of Colorado Hospital

Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or large B-cell lymphoma patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release


Protocol #18-1943, No Longer Enrolling: 11/28/2019
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03601442

Molecular Genomic Profiling of Glassy Cell Cervical Carcinoma


Protocol #18-1898, No Longer Enrolling: 11/28/2019
Locations: University of Colorado Hospital

Patient derived cell lines and ex vivo slice cultures for evaluation of autophagy inhibition in central nervous system tumors


Protocol #18-1815, No Longer Enrolling: 11/28/2019
Locations: Childrens Hospital Colorado

Evaluation of breast asymmetries with 3D mammography; can biopsy be avoided?


Protocol #18-1634, No Longer Enrolling: 11/28/2019
Locations: University of Colorado Hospital

Identifying cancer biomarkers using natural-language processing methods


Protocol #18-1987, No Longer Enrolling: 11/28/2019
Locations: University of Colorado Hospital

Precision treatment of acute myeloid leukemia


Protocol #18-1861, No Longer Enrolling: 11/28/2019
Locations: University of Colorado Hospital

Single Patient IND for ATA129, IND# [IND#], Patient JB


Protocol #19-2297, No Longer Enrolling: 11/1/2019
Locations: Childrens Hospital Colorado

A Phase 1b/2, Open-Label, Multicenter Dose-Escalation and Dose-Expansion Study of the Combination of RMC-4630 and Cobimetinib in Adult Participants with Relapsed/Refractory Solid Tumors and a Phase 1b Study of RMC-4630 with Osimertinib in Participants with Epidermal Growth Factor Receptor Mutation Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer


Protocol #19-1132, No Longer Enrolling: 7/29/2021
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03989115

Current status of Neurosurgical Oncology in Tanzania: Opportunities for international Collaboration


Protocol #19-1766, No Longer Enrolling: 10/22/2019
Locations: University of Colorado Hospital

Immunohistochemical characterization of archival surgical lung pathology specimens


Protocol #19-1742, No Longer Enrolling: 12/24/2019
Locations: University of Colorado Hospital

Vestibular nerve preservation in vestibular schwannoma surgery for facial and cochlear nerve function preservation


Protocol #19-1970, No Longer Enrolling: 10/22/2019
Locations: University of Colorado Hospital

Single Patient IND for Tisagenlecleucel (CTL019), IND#18474


Protocol #18-1940, No Longer Enrolling: 11/1/2019
Locations: Childrens Hospital Colorado

PERFECT: A Phase 3, Randomized. Placebo-Controlled, Double Blind, Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Patients with Pulmonary Hypertension due to Chronic Obstructive Pulmonary Disease (PH-COPD)

This study is a 34 week cross over study with a treatment period of 26 weeks. After screening criteria is met, the subject will receive either active drug or placebo, have a one week "washout" period in which the subject will not receive any medication, then the subject will have another 12 weeks of treatment. (If the subject received active drug in the first 12 weeks he/she will receive placebo during this 12 weeks and previous placebo subjects will receive active drug. Procedures that will be conducted during the study are: completion of quality of life questionnaires, EKGs, laboratory assessments, Pulmonary Function tests, and 6 minute walk tests. Each visit will take approximately 2 hours.
Protocol #18-0761, No Longer Enrolling: 5/3/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03496623

Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (The COAPT Trial)

Prospective, randomized, parallel-controlled, multicenter clinical evaluation of the MitraClip device for the treatment of clinically significant functional mitral regurgitation in symptomatic heart failure subjects who are treated per standard of care and who have been determined by the site's local heart team as not appropriate for mitral valve surgery. Eligible subjects will be randomized in a 1:1 ratio to the MitraClip device (Device group) or to no MitraClip device (Control group). As part of the COAPT trial, a subset of patients (at least 50 up to 100 in total) will be registered in the CPX Sub-study, which is designed as a prospective, randomized (1:1 ratio to the MitraClip or no MitraClip device), parallel-controlled, multicenter study registering approximately 50-100 subjects in up to 50 qualified US sites from the COAPT trial. Subjects registered and randomized in the CPX Sub-study will contribute to the total enrollment approximately of 610 subjects in the COAPT trial. Roll-in subjects will not participate in the CPX Sub-study. The COAPT CAS study is designed as a prospective, multicenter, single arm, continued access registry study. A maximum of 800 subjects (anticipated) will be registered from up to 75 sites in the United States. The enrollment will end once pre-market approval (PMA) of the proposed expanded indication of MitraClip System is obtained. Active follow-up of patients will be performed through 12 months with scheduled visits at 30 days and 12 months. The national Trans catheter Valve Therapy Registry (TVT Registry) will be used for data collection through 12 months. Annual follow-up data from 2 years through year 5 post-implant will be obtained by linkage to the Centers for Medicare and Medicaid Services (CMS) Claims database. COAPT CAS data may be used to support the PMA application of the labeling claims for the treatment of moderate to severe or severe FMR in symptomatic heart failure subjects. This single arm registry will provide valuable new information regarding use of the MitraClip? NT System under more "real world" conditions.
Protocol #13-2266, No Longer Enrolling: 7/26/2023
Locations: University of Colorado Hospital

Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial

A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClip in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT) The objectives of this pivotal clinical trial are to evaluate the safety and effectiveness of the PASCAL System for transcatheter mitral valve repair compared to the MitraClip System in the treatment of patients with symptomatic degenerative mitral regurgitation (DMR) and who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team.
Protocol #18-2298, No Longer Enrolling: 7/26/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03706833

An Open-Label, Long-Term Safety Evaluation of Diazoxide Choline Controlled-Release Tablet in Patients with Prader-Willi Syndrome


Protocol #19-0079, No Longer Enrolling: 5/14/2022
Locations: Childrens Hospital Colorado

Impact of Air Pollution on Immunotherapy Outcomes in Bladder Cancer


Protocol #18-2742, No Longer Enrolling: 12/8/2022
Locations: Department Specific Free Standing Clinic, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT00000000

Adenosinergic immune suppression pathway in glioblastoma multiforme tumors


Protocol #19-2344, No Longer Enrolling: 12/7/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT00000000

A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY)

MEDLEY is a clinical study to research an investigational medicine for babies at high risk for respiratory syncytial virus (RSV) disease. The study is looking to see how safe the investigational medication is and if it works as well as a medication already approved to protect against RSV. The study will include about 1500 babies globally. If you decide to take part, your baby may be in the MEDLEY Study for up to 2 years and may have up to 17 scheduled study visits. Your baby will be monitored throughout the study for respiratory illnesses.
Protocol #19-1403, No Longer Enrolling: 10/26/2022
Locations: Childrens Hospital Colorado

A Protocol Comparing Temporary Transvenous Diaphragm Pacing to Standard of Care for Weaning from Mechanical Ventilation in ICU Patients (RESCUE 3)

This study assesses whether Lungpacer therapy plus usual medical care can safely improve the chances of patients on a breathing machine to regain the ability to breathe on their own as compared to usual medical care alone.
Protocol #19-2401, No Longer Enrolling: 1/6/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03783884

Hemodynamic-GUIDEd Management of Heart Failure (GUIDE-HF)

The purpose of this study is to evaluate a heart pressure system called the CardioMEMS PA Sensor (referred to as "the device") in patients with heart failure. A small sensor is threaded through a vein into your heart on the tip of a catheter, and may allow your health care team to determine fluid balance in your body. The CardioMEMS HF System is FDA approved for a select group of patients. The study plans to see if it works in more patients. The study will also learn if using the device's data for other indicators of heart failure might reduce worsening heart failure resulting in visits to the hospital to treat heart failure or death. You may be eligible if you are at risk of having episodes of worsening heart failure.
Protocol #18-2129, No Longer Enrolling: 5/12/2022
Locations: Medical Center of the Rockies, Memorial Hospital Central, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT00531661

The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension


Protocol #19-0159, No Longer Enrolling: 8/15/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03614260

A Phase 2a, Randomized, Open-Label, Active Control, Multi-Center Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de novo Kidney Transplant Recipients

This is a Phase 2a, randomized, open-label, active control, multi-center study to assess the efficacy and safety of bleselumab in preventing the rFSGS in de novo kidney transplant subjects. Primary Objective: - To assess the efficacy of the bleselumab regimen (basiliximab induction, tacrolimus, steroids and bleselumab) compared with the SOC regimen (basiliximab induction, tacrolimus, steroids and MMF) in the prevention of the recurrence of focal segmental glomerulosclerosis (rFSGS) defined as nephrotic range proteinuria with proteincreatinine ratio (> or equal to 3.0 g/g) through 3 months post-transplant. Death, graft loss or lost to follow-up will be imputed as rFSGS. Secondary Objectives: - To assess the incidence of nephrotic range proteinuria with protein-creatinine ratio (> or equal to 3.0 g/g) through 6 and 12 months post-transplant. Death, graft loss or lost to follow-up will be imputed as rFSGS. - To assess the incidence of biopsy-proven acute rejection (BPAR, Banff Grade ≥ 1; local read) through 3, 6 and 12 months post-transplant. - To assess the incidence of efficacy failure defined as BPAR (Banff Grade ≥ 1; local read), death, graft loss or lost to follow-up through 12 months post-transplant. - To assess the incidence of biopsy-proven (blinded, central read) rFSGS through 3, 6 and 12 months post-transplant. - To assess the safety of the bleselumab regimen compared with the SOC regimen.
Protocol #17-1010, No Longer Enrolling: 10/10/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02921789

Nutrition in Older HIV-Infected Adults Receiving ART: Impacts of Food Insecurity on Frailty and Disease Progression


Protocol #17-2145, No Longer Enrolling: 9/14/2023
Locations: University of Colorado Hospital

Effect of breaking up prolonged sitting on metabolic flexibility

Our objective is to test the effect of breaking-up prolonged sitting with bouts of physical activity on metabolic flexibility, a recognized core component of metabolic health. Metabolic flexibility is defined as the body's ability to adapt fuel oxidation to changing fuel availability and energy demands.
Protocol #14-0429, No Longer Enrolling: 5/20/2021
Locations: CTRC-adult, University of Colorado Hospital

Immune Profiling of Squamous Cell Carcinomas


Protocol #16-2436, No Longer Enrolling: 11/23/2019
Locations: University of Colorado Hospital

Using chronic epilepsy monitoring to study the role of parietal and occipital cortex in movement initiation and perception


Protocol #17-0321, No Longer Enrolling: 5/2/2020
Locations: University of Colorado Hospital

CORONARY ARTERY CALCIFICATION IN TYPE I DIABETES


Protocol #97-661, No Longer Enrolling: 9/24/2021
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT00005754

Dialysis Access Data Repository

This study is designed to collect data for future investigation under the topic of perioperative care and variables affecting outcomes of dialysis access patients at UCHealth.
Protocol #17-1073, No Longer Enrolling: 8/18/2021
Locations: Department Specific Free Standing Clinic, University of Colorado Hospital

NRG-BN001 Randomized Phase II Trial of Hypofractionated Dose-Escalated Photon IMRT or Proton Beam Therapy Versus Conventional Photon Irradiation with Concomitant and Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma

This is a clinical trial of temozolomide that will be administered by mouth which is standard of care along with standard dose radiation therapy that is standard of care or with higher dose radiation therapy which is investigational.
Protocol #14-2131, No Longer Enrolling: 5/13/2022
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital
More information available at ClinicalTrials.gov: NCT02179086

Half-normal saline vs normal saline for irrigation of open-irrigated radiofrequency catheters in left ventricular outflow tract arrhythmias ablation


Protocol #18-2772, No Longer Enrolling: 9/7/2023
Locations: University of Colorado Hospital

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects with Symptomatic Transthyretin Amyloid Cardiomyopathy


Protocol #19-0225, No Longer Enrolling: 10/14/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03860935

The Laboratory for Advanced Medicine (LAM) / Prospective Clinical Trial to Detect Liver Cancer through Quantification of cfDNA Methylation in Blood Samples (CLiMB)


Protocol #19-1272, No Longer Enrolling: 12/10/2022
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03694600

An Open-Label, Multi-Center Patient Access Program of Olaratumab for the Treatment of Soft Tissue Sarcoma


Protocol #19-2529, No Longer Enrolling: 7/12/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03994627

CROCODILE Study: Control of Renal Oxygenation, COnsumption, mitochondrial Dysfunction, and InsuLin rEsistance


Protocol #19-1282, No Longer Enrolling: 10/5/2023
Locations: Childrens Hospital Colorado, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04074668

A Phase 1/2, Open-Label Safety and Dose-Finding Study of Adeno-Associated Virus (AAV) Serotype 8 (AAV8)-Mediated Gene Transfer of Human Ornithine Transcarbamylase (OTC) in Adults with Late-Onset OTC Deficiency


Protocol #16-0927, No Longer Enrolling: 8/16/2021
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02991144

A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the INTERCEPT Blood System for Red blood cells in Subjects undergoing Complex Cardiac Surgery Procedures (the ReCePI study)


Protocol #18-2032, No Longer Enrolling: 10/19/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03459287

A5371: A Single-Arm, Open-Label, Pilot Study of Semaglutide for Non-Alcoholic Fatty Liver Disease (NAFLD), a Metabolic Syndrome with Insulin Resistance, Increased Hepatic Lipids, and Increased Cardiovascular Disease Risk (The SLIM LIVER Study)

About 30-40% of people living with HIV have a condition called NAFLD, or non-alcoholic fatty liver disease. NAFLD is caused by high levels of stored fat in the liver. Most people with NAFLD also have other complications like high cholesterol, obesity, increased belly fat or type 2 diabetes. These complications can lead to cardiovascular disease (any disease of the heart or blood vessels that can lead to a stroke or heart attack). In fact, most of the health problems that are associated with NAFLD are related to these conditions of the heart or metabolism. Without treatment, NAFLD can advance to more serious liver disease. By using a drug that can lower the level of stored fat in the liver, people living with HIV may be able to treat NAFLD and reduce their risk of cardiovascular disease and other complications.
Protocol #19-2824, No Longer Enrolling: 11/17/2022
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04216589

Single Patient IDE for Medtronic Vantage, IDE G170234, pt RC


Protocol #20-0292, No Longer Enrolling: 2/11/2020
Locations: University of Colorado Hospital

Preconception Counseling: Prospective evaluation of subsequent pregnancy outcomes


Protocol #19-2760, No Longer Enrolling: 8/4/2023
Locations: University of Colorado Hospital

A phase II study to evaluate neoadjuvant osimertinib therapy in patients with surgically resectable, EGFRmutant non-small cell lung cancer


Protocol #19-0325, No Longer Enrolling: 8/5/2022
Locations: Lone Tree Medical Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03433469

Individual Patient Program for Patients with BRAF V600E/K mutation-positive Metastatic Melanoma and Other Indications with Clinical Evidence of Potential Treatment Efficacy Treatment with Trametinib and Bevacizumab


Protocol #19-2412, No Longer Enrolling: 8/20/2021
Locations: Childrens Hospital Colorado

Quadriceps Tendon Autograft, Tendon-Bone versus All-Soft-Tissue for Anterior Cruciate Ligament Reconstruction: A Patient-Blinded Randomized Clinical Trial

Participants will be randomized into one of two treatment groups. In one treatment group, participants will receive the quadriceps tendon and patellar bone autograft. The second treatment group will received the all quadriceps tendon autograft. Both graft types are validated and widely used surgical approached in the pediatric and adolescent populations. We will follow participants for up to 5 years following their surgery. Participants' treatment will not differ from the normal standard of care treatment all patients receive, other than being randomized to a particular treatment group and completing questionnaires about pain and physical functioning periodically throughout treatment.
Protocol #19-1445, No Longer Enrolling: 2/28/2020
Locations: Childrens Hospital Colorado

Tracking the Natural History of Facial Skin Health in Pre and Peri Menopausal Breast Cancer Patients Undergoing Chemotherapy and / or Endocrine Therapies: A Feasibility Study


Protocol #18-2444, No Longer Enrolling: 2/14/2023
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04035408

COVID-19 Biobank


Protocol #20-0685, No Longer Enrolling: 5/21/2021
Locations: Childrens Hospital Colorado, Department Specific Free Standing Clinic, University of Colorado Hospital

A MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF BREXANOLONE IN THE TREATMENT OF ADOLESCENT FEMALE SUBJECTS WITH POSTPARTUM DEPRESSION


Protocol #19-1305, No Longer Enrolling: 4/9/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03665038

NRG-GY021: A Phase II Randomized Trial of Olaparib Versus Olaparib Plus Tremelimumab in Platinum-Sensitive Recurrent Ovarian Cancer


Protocol #19-2780, No Longer Enrolling: 10/20/2020
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04034927

A Phase I/II, Open-Label, Multicenter Study to Assess the Safety,Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD9008 in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with EGFR or HER2 mutation


Protocol #19-2390, No Longer Enrolling: 2/4/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03974022

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene


Protocol #20-0346, No Longer Enrolling: 5/27/2022
Locations: Brain Imaging Center (BIC), Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04374136

A Phase 2 randomized, placebo-controlled, double-blind, dose-ranging study evaluating LTI-01 (single-chain urokinase plasminogen activator, scuPA) in patients with infected, non-draining pleural effusions

A randomized, double-blind study, placebo-controlled, multi-center, dose-ranging study in hospitalized patients with infected, non-draining pleural effusions. LTI-01 or placebo will be administered through the vein once daily for up to 3 days to facilitate pleural (lung) fluid draining.
Protocol #20-0436, No Longer Enrolling: 9/25/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04234919

PULSE-PHPF-001: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLEDCLINICAL STUDY TO ASSESS THE SAFETY AND EFFICACYOF PULSED, INHALED NITRIC OXIDE (iNO) IN SUBJECTS WITH PULMONARY HYPERTENSION ASSOCIATED WITH PULMONARY FIBROSIS ON LONG TERM OXYGEN THERAPY (PART 1 AND PART 2)

This is a 16 week study of iNO vs placebo. Once the subject meets criteria, the subject will be required to visit the clinic once a month for 16 weeks. There is an open label extension available for this study in which the subject will be guaranteed to get the actual study drug. The subject must complete the main study to qualify for the open label extension. Study procedures that will be completed during the study are the completion of quality of life questionnaires, 6 minute walk tests, pulmonary function tests, echocardiograms and laboratory assessments. Study required testing will be paid for but the Sponsor. Most visits will take approximately 2 hours.
Protocol #17-1863, No Longer Enrolling: 9/6/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03267108

The Brain Vascular Malformation Clinical Consortium (BVMC3) Project 3: Cerebral Hemorrhage Risk in Hereditary Hemorrhagic Telangiectasia

To identify genetic and circulating biomarkers of severe bleeding and predictors of brain outcomes in HHT patients. Patients will be evaluated about every 18 months for up to 10 years
Protocol #20-0039, No Longer Enrolling: 6/2/2020
Locations: University of Colorado Hospital

A Phase 1/2 Study of REGN5093 in Patients with MET-Altered Advanced Non-Small Cell Lung Cancer


Protocol #19-1759, No Longer Enrolling: 8/12/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04077099

DEEP LEARNING BASED FEATURE EXTRACTION ON PANCREAS X-RAY PROJECTION IMAGES


Protocol #19-0123, No Longer Enrolling: 6/29/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT00000000

Prescribing Practices of Psychotropic Medications by Oncology Providers at the University of Colorado Cancer Center


Protocol #19-0181, No Longer Enrolling: 6/5/2020
Locations: University of Colorado Hospital

Identifying the Criteria that Constitute Value for Pediatric Healthcare Interventions


Protocol #19-0779, No Longer Enrolling: 6/5/2020

Immunoglobulin heavy chain and T-cell receptor gamma rearrangements in acute myeloid leukemia as a potential target for minimal residual disease testing


Protocol #19-0922, No Longer Enrolling: 6/5/2020
Locations: Childrens Hospital Colorado

Lymph Node Sampling in Pediatric Renal Tumors: Survey of Current Practices and Impact of Education


Protocol #19-0596, No Longer Enrolling: 6/5/2020
Locations: Childrens Hospital Colorado

Targeting the Regulation and Actions of Telomerase Reverse Transcriptase (TERT) in Bladder Cancer


Protocol #19-1407, No Longer Enrolling: 6/5/2020

Impact on outcomes after omitting vincristine or vinblastine due to neuropathy in treatment of lymphoma


Protocol #19-1512, No Longer Enrolling: 6/5/2020
Locations: University of Colorado Hospital

An assessment of the most commonly used medications to treat neuropathic pain in adult patients with cancer


Protocol #19-1517, No Longer Enrolling: 6/5/2020
Locations: University of Colorado Hospital

Multiple Distinct Vascular Neoplasms Involving IDH1 Mutations Suggest a Mosaic Pattern of Expression of IDH1 Mutants


Protocol #19-1568, No Longer Enrolling: 6/5/2020
Locations: University of Colorado Hospital

All-patient cancer center expansion of support services (ACCESS) for tobacco cessation treatment


Protocol #17-2279, No Longer Enrolling: 6/5/2020
Locations: University of Colorado Hospital

Ki67 as a Novel Graded Marker of Proliferative Activity in Colorectal Liver Metastasis


Protocol #19-1799, No Longer Enrolling: 6/5/2020
Locations: University of Colorado Hospital

Adherence to follow-up recommendations after cryotherapy for high-grade cervical dysplasia


Protocol #20-0202, No Longer Enrolling: 6/5/2020
Locations: Denver Health Medical Center

COVID-19 Prospective Observational Cohort Study and Biobank of Health Care Workers and Other Populations


Protocol #20-1197, No Longer Enrolling: 1/4/2022
Locations: Barbara Davis Center, Childrens Hospital Colorado, University of Colorado Hospital

Post Event-Cardiovascular Risk Perception Survey (PE-CRPS): Validity and Reliability in Cardiac Patients Post Heart Event

The purpose of the study is to test for validity and reliability in the revised Post Event Cardiovascular Risk Perception Survey (PE-CRPS) among individuals who are diagnosed with heart disease (post heart event). The purpose of the study is to test for validity and reliability in the revised Post EventCardiovascular Risk Perception Survey (PE-CRPS) among individuals who are diagnosed with heart disease (post heart event). The researchers plan to learn more about how individuals perceive their chance of developing certain cardiac risk factors after they have had a heart event such as after having a heart attack, or having cardiac surgery. If you join the study you will help us learn about: 1) what patients perceive their chance of developing certain cardiac risk factors, 2) how to structure cardiac rehab programs.
Protocol #20-6019, No Longer Enrolling: 3/2/2023
Locations: Memorial Hospital Central

Improving upon implantation and programming of directional leads in deep brain stimulation (DBS) for movement disorders


Protocol #20-0232, No Longer Enrolling: 7/14/2020
Locations: University of Colorado Hospital

Taste buds in COVID-19 patients


Protocol #20-1325, No Longer Enrolling: 7/16/2020
Locations: University of Colorado Hospital

Virtual reality in cancer patient imaging review


Protocol #20-0560, No Longer Enrolling: 7/7/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04469478

A Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid polyneuropathy


Protocol #19-2873, No Longer Enrolling: 7/23/2020
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04136184

RTOG 1216 Randomized Phase II/III Trial of Adjuvant Radiation Therapy with Cisplatin, Docetaxel-Cetuximab, or Cisplatin-Atezolizumab in Pathologic High-Risk Squamous Cell Cancer of the Head and Neck

This is a clinical trial investigating the effects of the following different radiation and drug pairings of which the patient will be randomly assigned: Radiation therapy and Cisplatin(Standard of Care), Radiation therapy and Cisplatin(Investigational treatment) or Radiation therapy and Docetaxel/ Cetuximab(Investigational treatment)
Protocol #14-1299, No Longer Enrolling: 2/18/2021
Locations: Lone Tree Medical Center, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT01810913

Motor Outcomes to Validate Evaluations in FSHD


Protocol #20-0405, No Longer Enrolling: 8/5/2020
Locations: University of Colorado Hospital

Single Patient IDE for Medtronic SynchroMed II Pump with Intera Tapered Catheter, IDE# U200202, Pt. MM


Protocol #20-1988, No Longer Enrolling: 7/9/2022
Locations: University of Colorado Hospital

A Phase 1/2 Study of ALKS 4230 Administered Intravenously as Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors- ARTISTRY-1


Protocol #19-2532, No Longer Enrolling: 7/28/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02799095

A SINGLE-PERIOD, SINGLE-TREATMENT STUDY OF THE PHARMACOKINETICS AND PHARMACODYNAMICS OF EPINEPHRINE AFTER ADMINISTRATION OF INTRANASAL ARS-1 TO PEDIATRIC SUBJECTS WITH SYSTEMIC ALLERGIES


Protocol #20-0596, No Longer Enrolling: 10/4/2023
Locations: Childrens Hospital Colorado

Radicava?/(Edaravone) Findings in Biomarkers From ALS (REFINE-ALS)


Protocol #19-1560, No Longer Enrolling: 8/18/2020
Locations: University of Colorado Hospital

Intervention to Educate and Improve Underserved Populations' Uptake and Completion of the HPV Vaccine Series


Protocol #19-2236, No Longer Enrolling: 11/28/2023
Locations: Denver Health and Hospital Authority, Department Specific Free Standing Clinic, High Plains Community Health Center, High Plains Community Health Center, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04611022

A Novel Patient Decision Aid for Surrogate Decision Makers of Comatose Survivors of Cardiac Arrest: A Pilot Study


Protocol #19-0795, No Longer Enrolling: 3/14/2023
Locations: University of Colorado Hospital

Clinical Trial of Gastrostomy Button Securement Device

This is a mult-center trial where up to 200 pediatric patients will be enrolled. pediatric patients who have a gastrostomy tube placed will be eligible for enrollment and will be randomized to either receive the standard of care tic-tac-toe dressing or the new Button Huggie gastrostomy tube securement device. The patients will be followed at 4, 8, and 12 weeks after placement of the device or dressing to determine satisfaction with the device as well as post-operative outcomes.
Protocol #18-1615, No Longer Enrolling: 9/18/2020
Locations: Childrens Hospital Colorado, Childrens Hospital Colorado at Memorial

EA5191: A Randomized Phase II Trial of Cabozantinib and Cabozantinib Plus Nivolumab Versus Standard Chemotherapy in Patients with Previously Treated Non-Squamous NSCLC


Protocol #20-1737, No Longer Enrolling: 3/18/2021
Locations: Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Poudre Valley Hospital
More information available at ClinicalTrials.gov: NCT04310007

NATURAL HISTORY STUDY OF MITOCHONDRIAL NEUROGASTROINTESTINAL ENCEPHALOMYOPATHY


Protocol #20-0091, No Longer Enrolling: 10/10/2020
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT01694953

VAC31518COV3001 | A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older

There will be at least 7 study visits, over 2 years. If symptoms develop visits will be more frequent
Protocol #20-2078, No Longer Enrolling: 10/16/2020
Locations: Anschutz Health and Wellness, Barbara Davis Center, Childrens Hospital Colorado, Renal Research Center
More information available at ClinicalTrials.gov: NCT04505722

Reducing the flow from a Fontan fenestration using Atrial Flow Regulator devices - Patient QW


Protocol #20-2505, No Longer Enrolling: 2/13/2021
Locations: Childrens Hospital Colorado

A PHASE 3, RANDOMIZED, DOUBLE- OR OBSERVER-BLINDED, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN INFANTS BORN TO WOMEN VACCINATED DURING PREGNANCY


Protocol #20-0481, No Longer Enrolling: 11/10/2022
Locations: Childrens Hospital Colorado, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04032093

Single Patient Device Compassionate Use for Medtronic SynchroMed II Pump with Intera Tapered Catheter, #U200271, Pt L.I.


Protocol #20-2406, No Longer Enrolling: 7/9/2022
Locations: University of Colorado Hospital

Single Patient Device Compassionate Use for Medtronic SynchroMed II Pump with Intera Tapered Catheter, #U200272, Pt M.W. (1)


Protocol #20-2407, No Longer Enrolling: 7/9/2022
Locations: University of Colorado Hospital

Single Patient Device Compassionate Use for Medtronic SynchroMed II Pump with Intera Tapered Catheter, #U200273, Pt M.W. (2)


Protocol #20-2410, No Longer Enrolling: 7/9/2022
Locations: University of Colorado Hospital

Trial of Early Antiviral Therapies during Non-hospitalized Outpatient Window (TREAT NOW) for COVID-19


Protocol #20-1227, No Longer Enrolling: 1/8/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04372628

ColorAdo ReseArch on Menopause & Early Life Stress Study: Remote Participation

HEALTHY FEMALES NEEDED FOR RESEARCH Dr. Christina Metcalf at the University of Colorado is investigating how early life experiences affect thinking, mood, and stress during the menopause transition. Study participation consists of five study sessions (all completed virtually from your home), over the course of 2 months. These visits will consist of questionnaires about your mood and some stressful life events; thinking and mood assessments; collection of hair, saliva, and blood microsamples; and a stress task. You may be eligible if you are: In late perimenopause or early post-menopause stage Not taking exogenous hormones Not taking steroid, nonsteroidal anti-inflammatories, beta-blocker medications, or certain supplements Not a smoker Participation in the study is voluntary. Eligible participants will receive compensation via e-gift cards for completing study activities.
Protocol #20-1715, No Longer Enrolling: 1/9/2024
Locations: Childrens Hospital Colorado, Department Specific Free Standing Clinic

CRESTONE: A Phase 2 Study of Seribantumab in Adult Patients with Neuregulin-1 (NRG1) Fusion Positive Locally Advanced or Metastatic Solid Tumors


Protocol #20-1736, No Longer Enrolling: 9/29/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04383210

ASFOTASE ALFA A Single Patient Access Treatment Plan for ASFOTASE ALFA (Human Recombinant Tissue-Nonspecific Alkaline Phosphatase Fusion Protein) Treatment for an Infant or Young Child with Hypophosphatasia (HPP)


Protocol #15-150, No Longer Enrolling: 12/1/2020
Locations: Childrens Hospital Colorado

Single Patient IND for Nirogacestat for treatment of desmoid fibromatosis in patient DC, IND# 154034


Protocol #20-2809, No Longer Enrolling: 12/11/2020
Locations: University of Colorado Hospital

Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19 (ASPEN-COVID-19)


Protocol #20-2972, No Longer Enrolling: 5/12/2022
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04655586

A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS


Protocol #20-0490, No Longer Enrolling: 8/18/2021
Locations: Childrens Hospital Colorado

COG AHEP1531 - Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)


Protocol #18-1527, No Longer Enrolling: 1/27/2024
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT03533582

Pre-Approval Access to Amivantamab in Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations who have Failed Platinum-Based Chemotherapy


Protocol #20-3119, No Longer Enrolling: 1/13/2021
Locations: University of Colorado Hospital

A Health System Wide Evaluation of Mandated Use and Clinical Decision Support Tools to Improve PDMP Utilization and Patient Outcomes


Protocol #19-1130, No Longer Enrolling: 12/8/2023
Locations: University of Colorado Hospital

Provider preferences in development of Clinical Decision Support Tools to improve PDMP utilizations


Protocol #19-3063, No Longer Enrolling: 11/28/2023
Locations: Boulder Health Center, Broomfield Hospital, CU Sports Medicine - Inverness Orthopedics, Grandview Hospital, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Longs Peak Hospital, Longs Peak Hospital, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Pikes Peak Regional Hospital, Poudre Valley Hospital, Steadman Hawkins Clinic - Denver (Inverness), UCHealth Central Park Medical Center, UCHealth Internal Medical Clinic - Lowry, UCHealth Inverness, University of Colorado Hospital

A Phase 1b, Randomized, Single-blind, Placebo-controlled, Multiple Ascending Dose (MAD) Study to Assess the Steady-State Pharmacokinetics and DQ8 Blocking Efficacy of Orally Administered IMT-002 in Patients with Type 1 Diabetes and HLA-DQ8


Protocol #20-2220, No Longer Enrolling: 6/6/2021
Locations: Barbara Davis Center

mHealth Development for Apathy among Patients with Mild Cognitive Impairment and their Care Partners


Protocol #19-3075, No Longer Enrolling: 8/15/2023
Locations: University of Colorado Hospital

A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus


Protocol #19-1748, No Longer Enrolling: 11/11/2022
Locations: Barbara Davis Center, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03978520

A Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy


Protocol #20-0094, No Longer Enrolling: 11/23/2023
Locations: Barbara Davis Center, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04058028

Non-Operative Management and Early Response Assessment in Rectal Cancer (NOM-ERA)

Non-Operative Management and Early Response Assessment in Rectal Cancer (NOM-ERA)
Protocol #20-2227, No Longer Enrolling: 1/26/2024
Locations: Memorial Hospital Central, Memorial Hospital North
More information available at ClinicalTrials.gov: NCT03904043

eCare: Developing a virtual stress management intervention for spousal/partnered employed caregivers of solid tumor cancer patients.

Caregivers and patients must agree to participate. Caregivers are defined as people married to or partnered with cancer patients who play a role in the patient's treatment and personal care. The interventions will last 8-12 weeks and study participation will last 12 months. Caregivers in all 3 groups (TAU, Virtual-PEPRR, or Pep-Pal) will provide biomarker samples (hair and saliva) that they will collect themselves at home, throughout the year (once they enroll at baseline and months 3, 6, 9 and 12). Materials will be mailed to the participants homes with instructions. All participants (caregivers and patients) will also fill out surveys/questionnaires at each of these 5 sample time points ( baseline, m3, m6, m9, m12) that will assess psychological measures (depression, anxiety and stress levels) and employment factors such as status, satisfaction, insurance and accommodations. Caregivers assigned to PEPPR will complete 8 hour long sessions of individualized training pertaining to stress management led by our licensed social worker, and caregivers in Pep-Pal will watch 12 videos pertaining to stress management. Our control group (TAU) will be encouraged to utilize resources outside the study."
Protocol #20-2458, No Longer Enrolling: 1/9/2024
Locations: Department Specific Free Standing Clinic, Grandview Hospital, Greeley Campus, Harmony Campus, Kaiser Permanente of Colorado, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Pikes Peak Regional Hospital, Poudre Valley Hospital, UCHealth - Scottsbluff, University of Colorado Hospital, Yampa Valley Medical Center
More information available at ClinicalTrials.gov: NCT04739696

Prospective, non-randomized, open label clinical study to assess the feasibility of the Bioabsorbable pulmonary valved conduit in subjects undergoing Right Ventricular Outflow Tract (RVOT) reconstruction Protocol No.:XEL-CR-03


Protocol #18-0444, No Longer Enrolling: 12/20/2023
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02700100

A221805: Duloxetine To Prevent Oxaliplatin-Induced Chemotherapy-Induced Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase IITo Phase III Study


Protocol #20-1705, No Longer Enrolling: 4/1/2023
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital
More information available at ClinicalTrials.gov: NCT04137107

A Randomized, Double-Blind, Placebo-Controlled Phase 1b Study to Assess the Safety and Effect of Repeated Administration of Granulocyte Colony-Stimulating Factor (G-CSF; filgrastim) on Hot Flashes and Other Vasomotor Symptoms of Menopause in Postmenopausal Women

The primary objective of this Phase 1b study is to assess the safety and pharmacodynamic (PD) effect of repeated subcutaneous injection of GCSF in healthy menopausal women. The secondary objective of this proposed study is to assess the efficacy of repeated administration of G-CSF in reducing the frequency and severity of hot flashes in postmenopausal women. The tertiary objective is to assess additional measures of hot flash burden.
Protocol #18-1254, No Longer Enrolling: 5/24/2022
Locations: Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03640754

Clinical Survey Study to Evaluate Biomarkers and Clinical Manifestations in Individuals with Glycogen Storage Disease Type III (GSD III)


Protocol #20-2123, No Longer Enrolling: 9/16/2022
Locations: Childrens Hospital Colorado

A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AK002 in Adult and Adolescent Patients with Active Eosinophilic Esophagitis

This is a Phase 2/3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and clinical benefit of AK002 in adult and adolescent patients with active and biopsy-proven EoE. Patients enrolled in the study will receive 6 infusions of placebo or AK002 administered every 4 weeks and will be followed for 8 weeks after the last dose. Subjects who complete the randomized, double-blind, placebo-controlled treatment (all 6 doses of placebo or AK002) and the Day 169 visit may have the option to receive 6 doses of open-label AK002 through participation in the OLE Period of the study. To evaluate the efficacy of AK002 in adult and adolescent patients with active EoE when compared to placebo, efficacy endpoints will be co-primary: 1) The proportion of patients who achieve a peak esophageal intraepithelial count of ≤6 eosinophils/hpf at Day 169 (Week 24). 2) Mean absolute change in Dysphagia Symptom Questionnaire (DSQ) score from Baseline to Weeks 23?24.
Protocol #19-3097, No Longer Enrolling: 3/2/2023
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04322708

CENTRAL VEIN SIGN: A DIAGNOSTIC BIOMARKER IN MULTIPLE SCLEROSIS


Protocol #20-1000, No Longer Enrolling: 3/19/2021
Locations: Brain Imaging Center (BIC), University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04495556

Pilot evaluation of COVID-19 serological conversion in MS patients


Protocol #21-2658, No Longer Enrolling: 3/19/2021
Locations: University of Colorado Hospital

Repository of Phase Signals for Pulmonary Hypertension Algorithm Development

This study is designed to collect a repository of resting phase signals from eligible subjects prior to right heart catheterization using the Phase Signal Recorder (PSR) for the purpose of development, testing and optimization of algorithms in the general population.
Protocol #20-6505, No Longer Enrolling: 11/16/2022
Locations: Memorial Hospital Central, Memorial Hospital North
More information available at ClinicalTrials.gov: NCT04031989

Complicated Appendectomies


Protocol #17-6100, No Longer Enrolling: 11/20/2021

A Randomized, Double-Blind Phase 3 Study of Ibrutinib in Combination With Corticosteroids versus Placebo in Combination With Corticosteroids in Subjects with New Onset Chronic Graft Versus Host Disease (cGVHD)


Protocol #17-0396, No Longer Enrolling: 4/30/2021
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT02959944

An Open-Label Extension of Study M15-736 to Evaluate the Safety and Tolerability of 24-Hour Daily Exposure of ABBV-951 in Subjects with Advanced Parkinson's Disease


Protocol #20-2130, No Longer Enrolling: 3/23/2021
Locations: University of Colorado Hospital

Real World Observational Study using clonoSEQ? Next Generation Sequencing in Hematologic Malignancies: The 'Watch' Registry


Protocol #20-2108, No Longer Enrolling: 6/15/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04545333

PRESERVE 1: A Phase 3 Randomized, Double-blind Trial of Trilaciclib versus Placebo in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer


Protocol #20-6514, No Longer Enrolling: 9/2/2022
Locations: Memorial Hospital Central, Memorial Hospital North
More information available at ClinicalTrials.gov: NCT04607668

A Phase 2 Study of VS-6766 (Dual RAF/MEK Inhibitor) as a Single Agent and In Combination with Defactinib (FAK Inhibitor) in Recurrent KRAS-Mutant (KRAS-MT) and BRAF-Mutant (BRAF-MT) Non-Small Cell Lung Cancer (NSCLC) (RAMP 202)


Protocol #20-2995, No Longer Enrolling: 7/11/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04620330

A Phase 3, Prospective, Multi-Center, Single-Arm, Open-Label Study to Evaluate LevoCeptTM, a Long-Acting Reversible Intrauterine System for Contraceptive Efficacy, Safety, and Tolerability


Protocol #20-1361, No Longer Enrolling: 3/29/2021
Locations: University of Colorado Hospital

Using intraoperative microelectrode recordings to study the role of the basal ganglia in movement initiation, and movement cessation.


Protocol #20-2979, No Longer Enrolling: 3/29/2021
Locations: University of Colorado Hospital

Time Restricted Feeding and Metabolic Rhythms in Humans


Protocol #16-2754, No Longer Enrolling: 6/10/2022
Locations: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

HERTHENA-Lung01: A Phase 2 Randomized Open-Label Study of Patritumab Deruxtecan (U3-1402) in Subjects with Previously Treated Metastatic or Locally Advanced EGFRmutated Non-Small Cell Lung Cancer (NSCLC)


Protocol #20-2222, No Longer Enrolling: 11/19/2021
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04619004

A PHASE 2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A SARS-COV-2 RNA VACCINE CANDIDATE (BNT162b2) AGAINST COVID-19 IN HEALTHY PREGNANT WOMEN 18 YEARS OF AGE AND OLDER

To determine the safety and efficacy of Pfizer COVID-19 vaccine in the pregnant population.
Protocol #21-2608, No Longer Enrolling: 4/9/2021
Locations: Childrens Hospital Colorado, UCHealth Internal Medical Clinic - Lowry, University of Colorado Hospital

The TULIP Study - Tissue-specific mechanisms UnderLying the unique Insulin resistance Phenotype in T1D

This study plans to learn more about the body's ability to use insulin and what kinds of substances are found in your muscles and fat tissue that may affect how your body uses insulin.
Protocol #19-0856, No Longer Enrolling: 1/5/2024
Locations: Barbara Davis Center, Outpatient CTRC, University of Colorado Hospital

Pneumonia in the ImmunoCompromised - Use of the Karius Test for the Detection of Undiagnosed Pathogens (PICKUP)


Protocol #20-1510, No Longer Enrolling: 3/17/2023
Locations: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04047719

Protocol A011-11 (STELLAR): A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH

The objective of this study is to evaluate the efficacy and safety of sotatercept treatment (plus background PAH therapy) versus placebo (plus background PAH therapy) at 24 weeks in adults with PAH.
Protocol #20-2581, No Longer Enrolling: 2/8/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04576988

A multicenter, non-comparative trial on the contraceptive efficacy, safety and tolerability of LPRI-424 (dienogest 2 mg / ethinyl estradiol 0.02 mg) during 13 cycles Multicenter, Non-Comparative Trial on the Contraceptive Efficacy, Safety, Tolerability of LPRI-424, 13 Cycles

? 9 visits over 13.5 months ? Physical Exam, Pelvic Exam ? Trans-Vaginal Ultrasound, Blood draws ? Daily e-diary completion
Protocol #19-2895, No Longer Enrolling: 7/22/2022
Locations: Comprehensive Women's Health Center

Myocardial Virus and Gene Expression in SARS CoV-2 Positive Patients 
with Clinically Important Myocardial Dysfunction

Myocardial dysfunction has emerged as an important pathophysiologic component of some critically ill patients with SARS CoV-2 (CoV-2) infections,1-5 either from myocarditis4, 5 or myocardial dysfunction without overt evidence of inflammatory disease.1-3 There are multiple unanswered questions regarding cardiac involvement in CoV-2 disease including: does the virus invade cardiac myocytes; if so, does it utilize the same host cellular machinery as in other cells; what are the relative roles of direct viral tissue injury vs. inflammatory myocardial disease; what cytokines are active in the myocardium; and what are the effects on functionally important cardiac myocyte genes and gene networks.
Protocol #20-0852, No Longer Enrolling: 3/31/2022
Locations: University of Colorado Hospital

A Phase 3, Open-label, Multi-center, Single Arm Study to Assess Contraceptive Efficacy and Safety of the Etonogestrel (MK-8415) Implant During Extended Use From 3 Years After Insertion in Females 35 Years of Age or Younger

? 11 visits over 27 months ? Physical Exam, Pelvic Exam, Pap smear (if needed), STI screening ? Blood draws ? Daily e-diary completion
Protocol #20-2734, No Longer Enrolling: 12/6/2022
Locations: Comprehensive Women's Health Center

Hybrid Closed-Loop Therapy in Pregnancies Complicated by Type 1 Diabetes (T1D)


Protocol #18-1798, No Longer Enrolling: 10/17/2023
Locations: Barbara Davis Center, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital

A081801 - INTEGRATION OF IMMUNOTHERAPY INTO ADJUVANT THERAPY FOR RESECTED NSCLC: ALCHEMIST CHEMO-IO


Protocol #20-2646, No Longer Enrolling: 1/19/2024
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04267848

An Open-Label, Multicenter, Follow-up Trial of ARGX-113-1904 to Evaluate the Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients With Pemphigus (ADDRESS+)


Protocol #20-2722, No Longer Enrolling: 6/21/2022
Locations: University of Colorado Hospital

The effect of rifampin on etonogestrel concentrations in contraceptive implant users

? 2 visits lasting 30 minutes ? Visit includes a blood draw, pregnancy test, and vital measurements.
Protocol #19-2829, No Longer Enrolling: 7/22/2022
Locations: Comprehensive Women's Health Center, Department Specific Free Standing Clinic

ICU Provider Perceptions Surrounding TBI and Trauma Oxygenation


Protocol #21-3428, No Longer Enrolling: 5/3/2023
Locations: University of Colorado Hospital

Comparison group experimental design of effectiveness of two resiliency interventions for nurses


Protocol #20-2689, No Longer Enrolling: 5/4/2022
Locations: Greeley Campus, Medical Center of the Rockies, Poudre Valley Hospital, Yampa Valley Medical Center

Our Community, Our Health Database: Characterizing Health Outcomes for Transgender and Gender Diverse Patients of UCHealth Integrated Transgender Program (UCH ITP) and Children's Hospital Colorado TRUE Center for Gender Diversity (TRUE)


Protocol #20-2302, No Longer Enrolling: 12/29/2021
Locations: Childrens Hospital Colorado, University of Colorado Hospital

My Baby, My Move+: A community wellness intervention


Protocol #19-1366, No Longer Enrolling: 8/9/2023
Locations: UCHealth Central Park Medical Center, UCHealth Internal Medical Clinic - Lowry, University of Colorado Hospital

Isolation of adult adipose derived stem cells from surgically discarded tissues such as liposuction aspirate and infrapatellar fat pads


Protocol #19-2997, No Longer Enrolling: 5/3/2023
Locations: UCHealth Steadman Hawkins Clinic - Denver (Inverness)

Evaluation of cannabis perception and usage in patients with epilepsy treated at the University of Colorado Hospital and Clinics


Protocol #20-0311, No Longer Enrolling: 9/2/2022
Locations: University of Colorado Hospital

GlobalSurg-CovidSurg Week: Determining the optimal timing for surgery following SARS-CoV-2 infection


Protocol #20-6083, No Longer Enrolling: 4/7/2022
Locations: Medical Center of the Rockies

Personalized seizure detection: leveraging wearable sensor data from the epilepsy monitoring unit to guide detection device recommendations


Protocol #21-3405, No Longer Enrolling: 5/24/2023
Locations: University of Colorado Hospital

A Prospective Observational Cohort Trial of outcomes and antibody responses following treatment with High-Titer Anti-SARS-CoV-2 in hospitalized COVID-19 patients.


Protocol #20-0986, No Longer Enrolling: 8/15/2023
Locations: Denver Health and Hospital Authority, Grandview Hospital, Greeley Campus, Highlands Ranch Hospital, Longs Peak Hospital, Longs Peak Hospital, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Pikes Peak Regional Hospital, Poudre Valley Hospital, St. Joseph Hospital, University of Colorado Hospital, Yampa Valley Medical Center

Comparative analysis of radiographical and clinical outcomes after cervical disc replacement with Mobi-C and M6-C implants


Protocol #21-3236, No Longer Enrolling: 8/20/2023
Locations: Highlands Ranch Hospital, Memorial Hospital North, University of Colorado Hospital

The influence of Weighted Blanket Therapy on Anxiety, Pain, and Restlessness in Critical and Progressive Care Patients


Protocol #21-3684, No Longer Enrolling: 9/22/2021
Locations: Long's Peak Hospital

Human intravenous Interferon Beta-Ia Safety and preliminary efficacy in hospitalized subjects with CoronavirUS (HIBISCUS)


Protocol #21-2690, No Longer Enrolling: 5/25/2022
Locations: Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04860518

A Phase 1b/2 Open Label Umbrella Study of Sasanlimab Combined with Anti-Cancer Therapies Targeting Multiple Molecular Mechanisms in Participants with Non-Small Cell Lung Cancer (NSCLC)


Protocol #20-2832, No Longer Enrolling: 7/15/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04585815

Pulsed Field Ablation to Irreversibly Electroporate Tissue and Tread AF


Protocol #21-2771, No Longer Enrolling: 1/22/2022
Locations: Medical Center of the Rockies
More information available at ClinicalTrials.gov: NCT04198701

Cerebrovascular Function in CKD and ADPKD: A Cross-Sectional Study


Protocol #17-2135, No Longer Enrolling: 7/28/2022
Locations: Renal Research Center

Cohort Study of Preclinical Pulmonary Fibrosis


Protocol #20-1739, No Longer Enrolling: 8/25/2021
Locations: University of Colorado Hospital

A Randomized Phase 3 Study of MRTX849 in Combination with Cetuximab Versus Chemotherapy in Patients with Advanced Colorectal Cancer with KRAS G12C Mutation with Disease Progression On or After Standard First-Line Therapy


Protocol #21-2951, No Longer Enrolling: 4/20/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04793958

Reiki Training and Resilience in Oncology Nurses: A Mixed Methods Study


Protocol #21-3644, No Longer Enrolling: 9/22/2021
Locations: University of Colorado Hospital

ELEVATE 2 (RVT-1201-2002): A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients with Pulmonary Arterial Hypertension

To evaluate the effect of rodatristat ethyl on the percent change from baseline pulmonary vascular resistance (PVR), as measured by right heart catheterization (RHC) in patients with PAH
Protocol #21-3433, No Longer Enrolling: 5/23/2023
Locations: Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04712669

LEAFLEX - A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Performance of the Leaflex Performer (The Leaflex Early Feasibility Study)


Protocol #20-3164, No Longer Enrolling: 5/16/2023
Locations: Harmony Campus, Medical Center of the Rockies
More information available at ClinicalTrials.gov: NCT04636073

A071401 Phase II Trial of SMO/ AKT/ NF2/CDK Inhibitors in Progressive Meningiomas with SMO/ AKT/ NF2/CDK Pathway Mutations


Protocol #15-1747, No Longer Enrolling: 1/27/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02523014

NRG-GY020: A PHASE III RANDOMIZED TRIAL OF RADIATION +/- PEMBROLIZUMAB (MK-3475) FOR NEWLY DIAGNOSED EARLY STAGE HIGH INTERMEDIATE RISK MISMATCH REPAIR DEFICIENT (dMMR) ENDOMETRIOID ENDOMETRIAL CANCER


Protocol #21-3887, No Longer Enrolling: 8/31/2022
Locations: Highlands Ranch Hospital, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04214067

"A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER-2 Negative Breast Cancer with Recurrence Score (RS) of 25 or Less. RxPONDER: A Clinical Trial RX for Positive Node, Endocrine Responsive Breast Cancer"


Protocol #UCH11-1079, No Longer Enrolling: 10/7/2022
Locations: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital
More information available at ClinicalTrials.gov: NCT01272037

Single Patient IND for the Emergency use of Atrial Flow Regulator (AFR) in a patient with severe pulmonary hypertension - Patient KP


Protocol #21-3829, No Longer Enrolling: 2/11/2022
Locations: Childrens Hospital Colorado

Implementation of a novel protocol to measure hypothalamic insulin sensitivity in vivo in human adults

In this study, we are looking at how the brain responds to insulin through stimulation with a glucose infusion
Protocol #21-2939, No Longer Enrolling: 4/4/2023
Locations: Brain Imaging Center (BIC), Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital

A Phase 1b, Open-Label, Pharmacokinetic, Pharmacodynamic, Safety and Tolerability Study of CERC-006 in Adults (Aged 18-31 Years) with Complex Lymphatic Malformations


Protocol #21-3050, No Longer Enrolling: 2/24/2022
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT04994002

Single Patient IDE for the use of Custom Made Covered Stent for patient RW


Protocol #21-4007, No Longer Enrolling: 2/16/2022
Locations: Childrens Hospital Colorado

A Phase 2 Study of BIO 300 Oral Suspension in Discharged COVID-19 Patients


Protocol #20-2986, No Longer Enrolling: 8/4/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04482595

A011202 A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3N1) Who Have Positive sentinel Lymph Node Disease after Neoadjuvant Chemotherapy

This is a clinical trial evaluating the Role of Axillary Lymph Node Dissection in Breast Cancer Patients
Protocol #14-0379, No Longer Enrolling: 7/16/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT01901094

A Phase 1/2 Study Targeting Acquired Resistance Mechanisms in Patients with EGFR Mutant Non-Small Cell Lung Cancer


Protocol #21-3585, No Longer Enrolling: 7/19/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04862780

A Phase 1/2 study of TPX-0131, a Novel Oral ALK Tyrosine Kinase Inhibitor, in Subjects with ALK+ Advanced or Metastatic NSCLC


Protocol #21-3413, No Longer Enrolling: 10/11/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04849273

A Phase 3b/4, Double-masked, randomized, International, Parallel-assignment, Multicenter Trial in Patients with Thyroid Eye Disease to Evaluate the Safety and Tolerability of Different Dosing Durations of Teprotumumab Protocol Number: HZNP-TEP-402

Patients will be randomized to receive one of the following study treatment lengths: 4 infusions of teprotumumab (Cohort [Group] 1), followed by either 4 infusions of teprotumumab or 4 infusions of placebo (Placebo looks like the study drug, but does not include the active ingredient found in teprotumumab.) or 8 infusions of teprotumumab (Cohort 2) or 16 infusions of teprotumumab (Cohort 3)
Protocol #21-3831, No Longer Enrolling: 6/10/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05002998

AMD Ryan Initiative Study (ARIS) - Longitudinal Study of Early AMD and Reticular Pseudodrusen

The goal of this project is to better understand the natural history and characteristics of early AMD. Another goal is to determine the course of the progression to intermediate and/or advanced AMD in eyes with early AMD and a certain finding associated with early AMD (Reticular Pseudodrusen).
Protocol #18-0520, No Longer Enrolling: 8/16/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT03092492

A Phase 2 Multicenter, Double-Masked, Randomized, Placebo-Controlled Study to Investigate the Long-Term Safety, Tolerability, Pharmocokinetics and Effects of ALK-001 on the Progression of Stargardt Disease

The TEASE studies (Tolerability and Effects of ALK-001 in Stargardt Disease) are a series of clinical trials evaluating an investigational drug called ALK-001 in people who have Stargardt Disease. There are no FDA-approved treatments to slow the progression of Stargardt Disease. Research studies are conducted to determine if an investigational drug is safe and effective.
Protocol #19-1103, No Longer Enrolling: 8/16/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT02402660

The Effect of Warm Compress Therapy Using the TearRestore Eyelid Warming Mask on Symptoms and Signs of Meibomian Gland Function

Study involves 1 - 2 clinic visits that last about 1 hour.
Protocol #18-1960, No Longer Enrolling: 12/22/2022
Locations: University of Colorado Hospital

A Phase 2 trial of AU-011 via suprachoroidal administration with a dose escalation phase (open-label, ascending single and repeat dose) and a randomized, masked dose expansion phase designed to evaluate the safety and efficacy of AU-011 in subjects with primary indeterminate lesions and small choroidal melanoma


Protocol #20-1186, No Longer Enrolling: 7/15/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04417530

A Phase 4, Randomized, Double-masked, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of TEPEZZA? in Treating Patients with Chronic (Inactive) Thyroid Eye Disease

Procedures include TEPEZZA infusions, blood draws, eye measurements. The trial lasts approximately 8-14 months and includes around 10-18 visits at the clinic.
Protocol #20-2835, No Longer Enrolling: 9/29/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04583735

Tivanisiran for Dry Eye in Subjects with Sjogren's Syndrome

Eye exam in both eyes and medical, ocular and surgical history review. Blood draw for eligibility including Sjogren's assessment (SSA, SSB) within 6 weeks prior to the Visit 1 and safety laboratory tests Study Duration: Approximately 3.5 to 4.5 months (includes a possible 6-week washout, a 14-day Run-In phase + 85-day double-masked active or vehicle treatment phase) total of 5 in-clinic visits.
Protocol #21-2624, No Longer Enrolling: 7/18/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04819269

Closed-loop guided breathing as a digital sleep aid to improve relaxation & sleep quality

Good sleep is important for good health. This research study will test a guided breathing experience to see if it can help people relax and fall asleep more easily.
Protocol #21-3977, No Longer Enrolling: 3/22/2022
Locations: Department Specific Free Standing Clinic

Usefulness and performance with the IrisVision head-mounted video low vision aid in young individuals with congenital or early onset visual impairment


Protocol #19-2383, No Longer Enrolling: 4/4/2023
Locations: University of Colorado Hospital

Field Test of Glaucoma Outcomes Survey


Protocol #20-2477, No Longer Enrolling: 9/2/2022
Locations: University of Colorado Hospital

The Influence of Combined Oral Contraceptives vs. Levonorgestrel Intrauterine Device on Weight, Body Composition, Eating Behaviors, and Appetite in Pre-menopausal Women with Overweight or Obesity


Protocol #21-3969, No Longer Enrolling: 1/20/2022
Locations: Comprehensive Women's Health Center, Outpatient CTRC

A Phase 3, Randomized, Adaptive Dose-Selection, Multi-Regional, Double- Masked, Parallel-Group, 3-Month Trial Evaluating the Safety and Efficacy of NCX 470 vs. Latanoprost 0.005% in Subjects with Open-Angle Glaucoma or Ocular Hypertension (Mont Blanc)


Protocol #20-0637, No Longer Enrolling: 9/22/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04445519

A PROSPECTIVE FIRST-IN-HUMAN STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF QR-1123 IN SUBJECTS WITH AUTOSOMAL DOMINANT RETINITIS PIGMENTOSA (adRP) DUE TO THE P23H MUTATION IN THE RHO GENE


Protocol #19-2294, No Longer Enrolling: 6/17/2022
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04123626

Single Patient IND for Relatlimab /Nivolumab FDC, IND 160470, Patient RH


Protocol #21-4946, No Longer Enrolling: 7/9/2022
Locations: University of Colorado Hospital

Single Patient IDE Treatment for Stryker Orthopaedics' Right Flanged Acetabular Cup with Locking Screws and GMRS to Restoration Modular Adapter for treatment of failed acetabular reconstruction in patient L.A.


Protocol #22-0150, No Longer Enrolling: 9/14/2022
Locations: University of Colorado Hospital

Single Patient IDE for the use of Custom Made Covered Stent for patient BH


Protocol #21-4539, No Longer Enrolling: 2/16/2022
Locations: University of Colorado Hospital

The effect of dronaderone on atrial fibrosis and atrial fibrillation recurrence post-ablation

EDORA is a multicenter, prospective, phase IV, randomized, and single-blinded clinical trial Purpose: Determine whether dronedarone is effective in slowing the progression of fibrosis and decreasing atrial arrhythmia (AA) recurrence (atrial fibrillation, atrial flutter, or atrial tachycardia) in patients who have undergone AF ablation therapy. Aim 1: Determine if dronedarone reduces post-ablation incidences of atrial arrythmia recurrence compared to placebo. Aim 2: Determine whether dronedarone is effective in slowing down the progression of fibrosis after ablation compared to SOC alone.
Protocol #21-3993, No Longer Enrolling: 11/16/2022
Locations: Memorial Hospital Central
More information available at ClinicalTrials.gov: NCT04704050

Use of Fenestrated Atrial Septal Occluder (FASD) in patient ILA (U210560) single patient IDE


Protocol #21-5091, No Longer Enrolling: 12/8/2022
Locations: University of Colorado Hospital

Use of Modified Covered Stent for patient VP (U220042)


Protocol #22-0270, No Longer Enrolling: 9/22/2022
Locations: Childrens Hospital Colorado

Single Patient compassionate use for Stanmore's JTS Non-Invasive Extendible Distal Femoral Replacement Implant in patient PC, U220053


Protocol #22-0363, No Longer Enrolling: 7/9/2022
Locations: Childrens Hospital Colorado

PROGRESS - A Prospective, Randomized Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement


Protocol #21-3680, No Longer Enrolling: 1/10/2024
Locations: Harmony Campus, Medical Center of the Rockies
More information available at ClinicalTrials.gov: NCT04889872

Single Patient IND for AEVI-007, IND# 159975 , Patient BM


Protocol #21-4949, No Longer Enrolling: 11/19/2022
Locations: Childrens Hospital Colorado

Associative Threat Learning: Measuring Mechanisms for Treating Threat-based Psychopathologies

This study plans to learn more about how performance on a behavioral task, the Facial Affect Salience Task (FAST, may predict responses to a 12-session course of exposure therapy in young adult females with social anxiety disorder. If the task can predict responses to treatment, we should see that demonstrated in how adults behavior during and after the therapy course. We should also see that reflected in how their brain responds. This study will not test wither the treatment therapy works. It is just the first step before a formal clinical test can be done. Participation involves: * Three study visits * 12-session therapy course
Protocol #21-2631, No Longer Enrolling: 4/15/2023
Locations: Brain Imaging Center (BIC), Childrens Hospital Colorado

Single Patient IND for Rebastinib (DCC-2036), IND #161291, LL


Protocol #22-0434, No Longer Enrolling: 5/10/2022
Locations: University of Colorado Hospital

Single Patient IND for Rebastinib (DCC-2036), IND# 161289


Protocol #22-0431, No Longer Enrolling: 6/15/2022
Locations: University of Colorado Hospital

Single Patient IND for Rebastinib (DCC-2036), IND #161295, VB


Protocol #22-0435, No Longer Enrolling: 6/15/2022
Locations: University of Colorado Hospital

A PHASE 1/2 STUDY OF REGN5093-M114 (METXMET ANTIBODY-DRUG CONJUGATE) IN PATIENTS WITH MET OVEREXPRESSING ADVANCED CANCER


Protocol #21-3772, No Longer Enrolling: 1/17/2024
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT04077099

Assessing diagnostic value of non-invasive FFRCT in coronary care in the emergency department

The overall purpose of this study is to help HeartFlow understand if the use of FFRCT in the ED will help physicians with diagnosis and treatment of chest pain. The primary objective of the ADVANCE-ED study is to compare decision plans prior to FFRCT with the actual decision made after FFRCT.
Protocol #22-0025, No Longer Enrolling: 11/16/2022
Locations: Memorial Hospital Central
More information available at ClinicalTrials.gov: NCT05325112

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged ≥2 to <18 years with Pulmonary Arterial Hypertension


Protocol #19-3001, No Longer Enrolling: 7/27/2023
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT04175600

Limb Differences Clinic

The purpose of this data collection is to track, characterize, and understand the impact of multidisciplinary, comprehensive care for all patients who attend the Limb Differences Clinic at Children’s Hospital Colorado. The project involves ongoing medical record review of patients seen in the Limb Differences Clinic at Children’s Hospital Colorado. A longitudinal database will be created and will encompass information that is routinely collected during clinic visits (e.g., demographic information and multidisciplinary clinical outcomes). Clinical information in the pre-operative, post-operative and rehabilitative time periods will be collected. In order to provide highly specialized and comprehensive clinical management for patients with limb differences a series of Patient Reported Outcomes (PRO) will be distributed at clinical appointments. These measures will capture the impact of the medical condition on the patient’s family, psychosocial and physical functioning, and quality of life. Such measures will be used to improve the clinical care provided to patients in the Limb Differences Clinic.
Protocol #21-4142, No Longer Enrolling: 11/9/2022
Locations: Childrens Hospital Colorado

A Multicenter, Cross-sectional Study to Characterize the Distribution of Lipoprotein(a) Levels Among Patients With Documented History of Atherosclerotic Cardiovascular Disease (ASCVD)

- Identify subjects with documented history of myocardial infarction (MI) and/or percutaneous coronary intervention (PCI) and lipoprotein(a) (Lp[a]) levels at or greater than 90 mg/dL or Lp(a) at or greater than 200 nmol/L - Evaluate the distribution of Lp(a) value in the overall subjects with documented history of MI and/or PCI - Evaluate the distribution of Lp(a) value in subjects with documented history of MI and/or PCI by demographics and regions
Protocol #22-0476, No Longer Enrolling: 12/14/2022
Locations: Memorial Hospital Central
More information available at ClinicalTrials.gov: NCT05378529

Neuromuscular training following concussion: a feasibility study using a virtual platform

Concussions pose a substantial burden for patients and have been found to increase the risk of sustaining a subsequent injury. The purpose of this study is to investigate deficits that may exist after clinical recovery in individuals with a history of concussion. We are currently seeking uninjured control participants ages 18-40 years who have NOT sustained a concussion/traumatic brain injury for a one-time research visit.
Protocol #20-3169, No Longer Enrolling: 9/20/2023
Locations: Department Specific Free Standing Clinic

A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease

This trial is testing a study medicine to learn if it can help prevent RSV infection in babies who are more likely to get severe RSV illness. Infants will be randomized to receive either Synagis or the study drug. There are approximately 3 blood draws per season, and participants will be asked to enter respiratory symptoms into an e-diary and return to the clinic for any respiratory illnesses. To evaluate the safety, tolerability, and efficacy of MK-1654 compared to palivizumab in infants at high risk for RSV
Protocol #21-4176, No Longer Enrolling: 9/30/2023
Locations: Childrens Hospital Colorado
More information available at ClinicalTrials.gov: NCT04938830

Research biobanking and distribution of organ donor biospecimen obtained through the Donor Alliance program


Protocol #21-4748, No Longer Enrolling: 9/30/2022
Locations: Donor Alliance

A Phase 3 Randomized, Active-Controlled, Double-Masked Study to Evaluate the Safety and Efficacy of TRS01 Eye Drops in the Treatment of Subjects with Active Non-infectious Anterior Uveitis including Subjects with Uveitic Glaucoma


Protocol #21-4454, No Longer Enrolling: 8/26/2023
Locations: University of Colorado Hospital
More information available at ClinicalTrials.gov: NCT05042609

A first in human, double-blind, randomized, intra-subject placebo-controlled, multiple dose study of QR-313 evaluating safety, proof of mechanism, preliminary efficacy and systemic exposure in subjects with Recessive Dystrophic Epidermolysis Bullosa (RDEB) due to mutation(s) in exon 73 of the COL7A1 gene


Protocol #18-1037, No Longer Enrolling: 1/14/2023
Locations: Childrens Hospital Colorado

IMPAACT 2021: Randomized Phase I/II Study of the Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Children 6 to 24 Months of Age, Version 1.0

The study will be conducted in children at selected sites in the United States. The vaccines will be evaluated in RSV-seronegative children ≥6 months (180 days) at the time of screening to <25 months (750 days) of age at the time of enrollment. Hypothesis: The live-attenuated RSV vaccine candidates RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, and RSV 276 will each be safe and immunogenic in RSV-seronegative recipients. However, these vaccine candidates may have safety signals that become apparent only when analyzed in a larger number of participants, and the candidates may differ in the magnitude and longevity of antibody responses, and in responses observed following naturally occurring RSV infection. To move forward, the vaccines should: be safe, and result in at least 70% of the population of vaccine recipients having a ≥4-fold rise in serum RSV-neutralizing antibody titers from pre-study product administration to the Day 56 Visit after study product administration The primary objectives of this study are the following: To estimate and compare (each vaccine group to placebo) the frequency and severity of adverse events (AEs) following study product administration (Day 0) through Day 56 To estimate and compare (between the vaccine groups and to the benchmark of 70%) the percentage of vaccinees having a ≥4-fold rise in serum RSV-neutralizing antibodies at the Day 56 Visit The secondary objectives of this study are to: To estimate and compare (between the vaccine groups) the percentage of vaccinees with a ≥4-fold rise in serum IgG antibody to RSV F protein (RSV F IgG) at the Day 56 Visit To estimate and compare (between the vaccine groups) the titers of serum RSV F IgG and serum RSV-neutralizing antibodies at the Day 56 Visit To describe and compare the frequency and severity of RSV-associated, medically attended, acute respiratory illness (RSV-MAARI) and RSV-associated, medically attended, acute lower respiratory illness (RSV-MAALRI) in the placebo and vaccine arms during RSV season. Potential participants must meet all of the following criteria in order to be included in this study: ≥6 months (defined as ≥180 days) of age at the time of screening and <25 months (defined as < 750 days) of age at the time of enrollment. In good health based on revie