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A Phase 1a/1b Study of ELVN-002 for the Treatment of Patients with HER2 Mutant Non-Small Cell Lung Cancer
CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital here are 4 parts to the trial. Part 1 is a dose escalation with ELVN-002 monotherapy for people with advanced stage solid tumors that have a HER2 mutation, amplification or high HER2 over-expression. Part 2 is an ELVN-002 monotherapy dose exploration where additional people may be enrolled... |
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Specialty Compared to Oncology Delivered Palliative Care for Patients with Acute Myeloid Leukemia - SCOPELeukemia
University of Colorado Hospital This is a cluster randomized comparative effectiveness trial of primary palliative care (PC) versus specialty PC in 1150 patients with acute myeloid leukemia (AML) and their caregivers.... |
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ORACLE: Observation of ResiduAl Cancer with Liquid Biopsy Evaluation
University of Colorado Hospital This study plans to learn more about if a blood test can predict whether cancer will recur (come back) after initial treatment. In some cases, cancer is cured after initial treatment, but in other cases, cancer cells remain in the body. These remaining cancer cells can grow over time. If... |
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PIKture-01: First-in-Human Study of the PI3KalphaH1047R Mutant-Selective Inhibitor OKI-219 as Monotherapy in Participants with Advanced Solid Tumors and in Combination with Endocrine Therapy or HER2 Targeted Therapy in Participants with Advanced Breast Cancer
CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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Blood Disorder Symptomatology Outcomes Network Patient Reported Outcomes (BISON-PRO) Quality of Life Study
Cherry Creek Medical Center, University of Colorado Hospital The BISON-PRO Quality of Life Study is a research study to measure symptoms and quality of life using online surveys in patients with blood disorders.... |
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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.
CU-RIC, University of Colorado Hospital This is a multi-institutional, open label, four-arm, non-comparator Phase 2 study of FOLFIRINOX in combination with 9-ING-41 and losartan for the treatment of adult patients with untreated metastatic pancreatic adenocarcinoma (PAC). This research study will begin with a Safety Run-In phase... |
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EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have Previously Received 2 to 5 years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer with an Increased Risk of Recurrence
Memorial Hospital Central, Memorial Hospital North |
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Total Cancer Care Protocol: A Lifetime Partnership with Patients Who Have or May be at Risk of Having Cancer (ORIEN)
Cherry Creek Medical Center, Highlands Ranch Hospital, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital This study plans to learn more about how to improve standard cancer care. Cancer is a tough disease to treat because few cancers behave in the same way. Recent research suggests that information stored in your blood, tissues and body fluids can be studied to change the way we treat cancer ... |
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Early Rebiopsy to Identify Mechanisms and Biomarkers of Tumor Cell Survival Following Systemic Therapy for Lung Cancer
Lone Tree Medical Center, University of Colorado Hospital The primary objective is to 1- Identify differences between pretreatment and early treatment tumor samples in patients whose tumors contain activating mutations and who will be treated with targeted agents as first-line therapy. a. Measurement of gene expression signatures of pre-and ear... |
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A Phase 1b Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of ATP150/ATP152, VSV-GP154 and Ezabenlimab (BI 754091) in Patients with KRAS G12D/G12V Mutated Pancreatic Ductal Adenocarcinoma
CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital This is an open-label, phase 1b study to evaluate the safety, tolerability, immunogenicity and preliminary efficacy of a heterologous prime-boost vaccine (protein and viral vector) regimen without/with the PD-1 inhibitor Ezabenlimab. COMPLETED - Part A (metastatic and locally advanced P... |
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Protocol 10505, A phase 1 and randomized phase 2 trial of selinexor and temozolomide in recurrent glioblastoma
University of Colorado Hospital This phase I/II trial tests the safety, side effects and best dose of selinexor given in combination with the usual chemotherapy (temozolomide) and compares the effect of this combination therapy vs. the usual chemotherapy alone (temozolomide) in treating patients with glioblastoma that ha... |
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Protocol 10553, "A Phase 2 Study of Darolutamide in Combination with Leuprolide Acetate in Hormone-Therapy Naïve Recurrent and/or Metastatic Androgen Receptor (AR) Positive Salivary Gland Cancer,"
University of Colorado Hospital This phase II trial tests how well darolutamide and leuprolide acetate work in treating patients with androgen receptor positive salivary cancer that has spread from where it first started (primary site) to other places in the body (metastatic), cannot be removed by surgery (unresectable) ... |
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Protocol A022102, A Randomized Phase III Trial of mFOLFIRINOX +/- Nivolumab vs. FOLFOX +/- Nivolumab for First-line Treatment of Metastatic HER2-Negative Gastroesophageal Adenocarcinoma (NCT05677490)
Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital |
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A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment-naïve Subjects with Advanced or Metastatic PD-L1 High (TPS ≥50%) Non-small Cell Lung Cancer Without Actionable Genomic Alterations (Tropion-Lung08)
Memorial Hospital Central, Memorial Hospital North |
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EA8134: InPACT- International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)
University of Colorado Hospital We want to see if we can improve the treatment of patients with penis cancer that has spread, like yours. The purpose of this study is to test treatments which might reduce the chances of the cancer coming back. Combinations of four different treatments are being studied: Surgery to rem... |
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Phase 1 Trial of Autologous HER2-specific CAR T cells in Pediatric Patients with Refractory or Recurrent Ependymoma
Childrens Hospital Colorado Because of your cancer diagnosis, we previously received your permission to make HER2 CAR T cells from the blood you provided. Now, because we have successfully made your HER2 CAR T cells, you will be asked to enroll on the Phase 1 treatment study. The treatment for the Phase 1 study will ... |
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EA1151: Tomosynthesis Mammographic Imaging Screening Trial (TMIST)
Highlands Ranch Hospital, Outpatient CTRC, University of Colorado Hospital Participants in this trial will be randomized to receive either 2D or 3D mammograms for the first 5 years of the research study, either ever year or every other year depending on personal risk factors. Information will be collected on breast cancer status for 8 years in total. ... |
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Protocol A022104, The Janus Rectal Cancer Trial: A Randomized Phase II/III Trial Testing the Efficacy of Triplet versus Doublet Chemotherapy to Achieve Clinical Complete Response in Patients with Locally Advanced Rectal Cancer
Cherry Creek Medical Center, Highlands Ranch Hospital, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital PRIMARY OBJECTIVE: I. To evaluate and compare the clinical complete response (cCR) rates in patients with locally advanced rectal cancer treated with neoadjuvant long-course neoadjuvant radiotherapy (LCRT) followed by neoadjuvant modified fluorouracil, irinotecan, leucovorin, and oxalip... |
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A Phase II Study of Olaparib (AZD2281) in Patients with Metastatic/Advanced Urothelial Carcinoma and other genitourinary tumors with DNA-Repair Defects.
University of Colorado Hospital PRIMARY OBJECTIVE: I. To evaluate the efficacy of olaparib in two cohorts of patients with metastatic/advanced non prostate genitourinary (GU) cancer pre-selected by DNA-repair defects as measured by overall response rate (ORR). SECONDARY OBJECTIVES: I. To describe the effect of t... |
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S1802: PHASE III RANDOMIZED TRIAL OF STANDARD SYSTEMIC THERAPY (SST) VERSUS STANDARD SYSTEMIC THERAPY PLUS DEFINITIVE TREATMENT (SURGERY OR RADIATION) OF THE PRIMARY TUMOR IN METASTATIC PROSTATE CANCER
Cherry Creek Medical Center, 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 PRIMARY OBJECTIVES: I. To compare overall survival in metastatic prostate cancer patients who are randomized to standard systemic therapy (SST) plus definitive treatment of the primary tumor versus standard systemic therapy alone. SECONDARY OBJECTIVES: I. To compare overall surviv... |
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PHASE 1/2 DOSE ESCALATION AND PRELIMINARY EFFICACY OF CD19 DIRECTED CAR T CELLS GENERATED USING THE MILTENYI CLINIMACS PRODIGY SYSTEM (UCD19 CART) IN PEDIATRIC PATIENTS WITH REPLASED AND/OR REFRACTORY B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA (B-ALL) AND B-CELL NON-HODGKIN'S LYMPHOMA (B-NHL)
Childrens Hospital Colorado |
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PBTC-049: A Phase I study of Savolitinib in Recurrent, Progressive or Refractory Medulloblastoma, High-Grade Glioma, Diffuse Intrinsic Pontine Glioma, and CNS tumors harboring MET aberrations
Childrens Hospital Colorado This is a dose escalation study of savolitinib administered orally once a day to patients with recurrent, progressive or refractory central nervous system tumors. There are three stages in this study: a dose escalation cohort, PK expansion cohort, and an efficacy expansion cohort. The dos... |
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A Phase I/Ib Study of Losartan in Combination with Sunitinib in the Treatment of Pediatric and Adult Patients with Relapsed or Refractory Osteosarcoma
Childrens Healthcare of Atlanta, Childrens Hospital Colorado, Outpatient CTRC, University of Colorado Hospital This study is designed to test the experimental combination of Losartan and Sunitinib in the hope of finding a drug combination that is safe and effective against osteosarcoma that has come back or not responded to standard therapy. There are two parts to this study. The first part is the... |
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LungMAP: A MASTER PROTOCOL TO EVALUATE BIOMARKER-DRIVEN THERAPIES AND IMMUNOTHERAPIES IN PREVIOUSLY-TREATED NON-SMALL CELL LUNG CANCER (Lung-MAP Screening Study)
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 This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid Master Protocol (Lung-MAP). The type of cancer trait (biomarker) ... |
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CCTG MA.39 TAILOR RT: A RANDOMIZED TRIAL OF REGIONAL RADIOTHERAPY IN BIOMARKER LOW RISK NODE POSITIVE BREAST CANCER
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 Women with node positive breast cancer normally will receive endocrine therapy and some may receive chemotherapy to help prevent the cancer from coming back. Many women will also receive radiotherapy to the whole breast/chest area and the surrounding lymph glands (called regional radiother... |
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Phase II Study of Induction FLOT Followed by Neoadjuvant Chemoradiation in Patients with Resectable Adenocarcinoma of the Esophagus or Gastroesophageal Junction
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 Clinical outcomes following standard of care therapy for resectable esophageal and gastroesophageal junction adenocarcinoma are suboptimal, with low rates of pathologic complete response (pCR) to current neoadjuvant treatment strategies. Although significant progress has been made by incor... |
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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
University of Colorado Hospital You are being asked to be in this research study because you have previously had surgery to remove your cancer and are now considered clinically disease-free. This study plans to learn more about whether or not the combination of pembrolizumab and mRNA-4157 (a personalized cancer vacci... |
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A Phase 2 Single Arm Open-Label Clinical Trial of ADP-A2M4 SPEAR T cells in subjects with Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma (SPEARHEAD 1 STUDY)
University of Colorado Hospital You are being asked to be in this research study because you have Synovial Sarcoma that has grown or not responded to treatment, and you completed the Pre-screening tests for this study. Your blood tested positive for certain proteins and your cancer cells tested positive for protein. T... |
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An Open-Label, Phase II Efficacy Trial of Doxorubicin in Combination with Dual Checkpoint Blockade using Zalifrelimab (AGEN1884) or Botensilimab (AGEN1181) with Balstilimab (AGEN2034) for Advanced or Metastatic Soft Tissue Sarcomas
University of Colorado Hospital The primary endpoint for the study is PFS6mo by RECIST 1.1. The sample size calculation is based on a Simon Two-Stage design with incorporation of early stopping rules for safety and futility (See section 9 for statistical considerations). The Investigators will enroll up to 35 patients on... |
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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)
Cherry Creek Medical Center, CTRC Inpatient, Highlands Ranch Hospital, Longs Peak Hospital, University of Colorado Hospital Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM. Its goals are to identify effective ... |
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NRG-HN010, A Controlled, Randomized Phase II Trial of Docetaxel Plus Trastuzumab Versus Ado-Trastuzumab Emtansine for Recurrent, Metastatic, or Treatment-Naïve, Unresectable HER2-Positive Salivary Gland Cancer (NCT05408845)
Highlands Ranch Hospital, University of Colorado Hospital This phase II trial tests whether ado-trastuzumab emtansine works to shrink tumors in patients with HER2-positive salivary gland cancer that has come back (recurrent), spread to other places in the body (metastatic), or cannot be removed by surgery (unresectable). Trastuzumab emtansine is ... |
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A PHASE 1/2, MULTI-CENTER, DOSE-ESCALATING STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS,
PHARMACODYNAMICS, AND EFFICACY OF QUIZARTINIB ADMINISTERED IN COMBINATION WITH RE-INDUCTION
CHEMOTHERAPY, AND AS A SINGLE-AGENT CONTINUATION THERAPY, IN PEDIATRIC RELAPSED/REFRACTORY AML SUBJECTS
AGED 1 MONTH TO < 18 YEARS (AND YOUNG ADULTS AGED UP TO 21 YEARS) WITH FLT3-ITD MUTATIONS
Childrens Hospital Colorado |
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AN OPEN-LABEL, MULTICENTER, PHASE 1B/2 STUDY OF RP1 IN SOLID ORGAN TRANSPLANT RECIPIENTS WITH ADVANCED CUTANEOUS MALIGNANCIES
CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital RP1 is a genetically modified herpes simplex type 1 virus that is designed to directly destroy tumors and to generate an anti-tumor immune response. This is a Phase 1B/2, open label, multicenter, trial evaluating the objective response rate and the safety and tolerability, biodistribution,... |
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S1827, "A Randomized Phase III Trial of MRI Surveillance with or without Prophylactic Cranial Irradiation (PCI) in Small-Cell Lung Cancer"
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 PRIMARY OBJECTIVE: I. To evaluate whether overall survival (OS) with magnetic resonance imaging (MRI) surveillance alone is not inferior to MRI surveillance combined with prophylactic cranial irradiation (PCI) for the treatment of small cell lung cancer (SCLC). SECONDARY OBJECTIVES: ... |
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NRG-GU011: A PHASE II DOUBLE-BLINDED, PLACEBO-CONTROLLED TRIAL OF PROSTATE OLIGOMETASTATIC RADIOTHERAPY WITH OR WITHOUT ANDROGEN DEPRIVATION THERAPY IN OLIGOMETASTATIC PROSTATE CANCER (NRG PROMETHEAN)
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 PRIMARY OBJECTIVE: I. Compare conventional radiological progression-free survival (rPFS) for positron emission tomography (PET)-detected, biochemically recurrent, oligometastatic, castration-sensitive prostate cancer patients treated with stereotactic ablative body radiation therapy (SA... |
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A First-in-Human, Two-Part, Open-Label, Phase I/II Study of DSP107 in Subjects with Advanced Solid Tumors Including a Dose-Escalation Safety Study (Part 1) and Preliminary Efficacy Assessment of DSP107 as Monotherapy and in Combination with Atezolizumab (Part 2)
University of Colorado Hospital Part 1 of the study is open to all solid tumors. Part 2 of the study will evaluate the safety, tolerability and preliminary efficacy of DSP107, administered either as monotherapy or in combination with atezolizumab. The study will enrol subjects with NSCLC that is wildtype for actionable... |
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A Phase 1/Randomized Phase 2 Study of M3814 (peposertib) in Combination with Hypofractionated Radiotherapy for the Treatment of Locally Advanced Pancreatic Adenocarcinoma
University of Colorado Hospital PRIMARY OBJECTIVES: I. To evaluate the safety and tolerability of M3814 (peposertib) in combination with hypofractionated radiotherapy in patients receiving treatment for locally advanced pancreatic adenocarcinoma (LAPC). (Phase I) II. To determine the difference in progression free sur... |
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A Randomized, Pragmatic, Adaptive trial of Metformin for Glucose Intolerance or Increased Body Mass Index in Prostate Cancer Patients
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, 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 Steadman Hawkins Clinic - Denver (Inverness), University of Colorado Hospital, Yampa Valley Medical Center In this study, subjects with prostate cancer will be randomized to metformin plus educational material for lifestyle modification versus educational material for lifestyle modification alone and followed for up to 10 years. Population-based, retrospective studies have reported improved out... |
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EPIK-P2: A Phase II double-blind study with an upfront, 16-week randomized, placebo-controlled period, to assess the efficacy, safety and pharmacokinetics of alpelisib (BYL719) in pediatric and adult patients with PIK3CA-related overgrowth spectrum (PROS)
Childrens Hospital Colorado This is a Phase II multi-center study with an upfront 16-week, randomized, double-blind, placebo-controlled period, and extension periods, to assess the efficacy, safety and PK of alpelisib in pediatric and adult participants with PROS.... |
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AN OPEN-LABEL FEASIBILITY STUDY TO ASSESS THE SAFETY AND PHARMACOKINETICS OF ENASIDENIB IN PEDIATRIC PATIENTS WITH RELAPSED/REFRACTORY ACUTE MYELOID LEUKEMIA (R/R-AML) WITH AN ISOCITRATE DEHYDROGENASE-2 (IDH2) MUTATION
Childrens Hospital Colorado The overall goals of this study are to: - Find out what effects, good and/or bad, enasidenib has on people with your AML cancer and IDH2 mutation. - To learn more about the side effects of enasidenib The study of enasidenib in children and young adults with AML is investigational. T... |
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A011801 - The CompassHER2 Trials (Comprehensive Use of Pathologic Response Assessment to Optimize Therapy in HER2-Positive Breast Cancer) CompassHER2 Residual Disease (RD), a Double-Blinded, Phase III Randomized Trial of T-DM1 Compared With T-DM1 and Tucatinib
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 |
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A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN328 Monotherapy and HPN328 with Atezolizumab or Ifinatamab Deruxtecan (I-DXd) in Patients with Advanced Cancers Associated with Expression of Delta-like Canonical Notch Ligand 3 (DLL3)
Outpatient CTRC, University of Colorado Hospital This study will investigate the maximum tolerated dose, the recommended dose for expansion (RDE), safety, efficacy, and pharmacokinetics of MK-6070 alone, MK-6070 with Atezolizumab and MK-6070 with I-DXd in participants with advanced cancers associated with expression of Delta-like Canonic... |
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A Phase Ib/III, Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)
Cherry Creek Medical Center, University of Colorado Hospital |
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A MULTICENTER PROSPECTIVE STUDY EVALUATING OUTCOMES OF ENDOSCOPIC ERADICATION THERAPY IN PATIENTS WITH BARRETT'S ESOPHAGUS ASSOCIATED NEOPLASIA: THE TREAT-BE (TREATMENT WITH RESECTION AND ENDOSCOPIC ABLATION TECHNIQUES FOR BARRETT'S ESOPHAGUS) CONSORTIUM
Moffit Cancer Center, University of South Florida, Northwestern University, UCLA - University of California, University of Colorado Hospital, University of Kansas Cancer Center, Washington University, Siteman Cancer Center |
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A PHASE 1 STUDY OF TJ033721 IN SUBJECTS WITH ADVANCED OR METASTATIC SOLID TUMORS
Outpatient CTRC, University of Colorado Hospital This study plans to learn more about the safety of a study drug called TJ033721 (givastomig). The study is designed in 2 Parts: Part 1 and Part 2. This consent from describes the details of Part 1, which will test different dose levels to find out what effects, both good and/or bad, the s... |
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NRG-GU009: PARALLEL PHASE III RANDOMIZED TRIALS FOR HIGH RISK PROSTATE CANCER EVALUATING DE-INTENSIFICATION FOR LOWER GENOMIC RISK AND INTENSIFICATION OF CONCURRENT THERAPY FOR HIGHER GENOMIC RISK WITH RADIATION (PREDICT-RT*)
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 PRIMARY OBJECTIVES: I. To determine whether men with National Comprehensive Cancer Network (NCCN) high risk prostate cancer who are in the lower 2/3 of Decipher genomic risk (=< 0.85) can be treated with 12 months androgen deprivation therapy (ADT) plus radiation therapy (RT) instead of... |
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A Prospective, Randomized, Controlled, Open-label, Multicenter Trial to Evaluate Efficacy, Safety and Patient-reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) with Lutetium (177Lu) Edotreotide compared to Best Standard of Care in Patients with Well-differentiated Aggressive Grade 2 and Grade 3, Somatostatin Receptor positive (SSTR+), Neuroendocrine Tumors of GastroEnteric or Pancreatic Origin (COMPOSE)
Outpatient CTRC, University of Colorado Hospital In the best standard of care (control) arm, each patient will receive best standard of care treatment (investigator’s choice [from the protocol comparator list]) according to individual risk‑benefit assessment, institutional protocols, the local Prescribing Information, local regulations o... |
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Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)
CTRC Inpatient, University of Colorado Hospital Assignment of patients to a cohort will be based on prior treatment as outlined in the eligibility criteria. Participants who discontinue pembrolizumab or vibostolimab+pembrolizumab after 35 infusions for reasons other than disease progression or intolerability, or who discontinue pembr... |
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S2001, Randomized Phase II Clinical Trial of Olaparib + Pembrolizumab vs. Olaparib Alone as Maintenance Therapy in Metastatic Pancreatic Cancer Patients with Germline BRCA1 or BRCA2 Mutations
Cherry Creek Medical Center, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital PRIMARY OBJECTIVE: I. To evaluate the progression free survival (PFS) of advanced pancreatic cancer patients with germline BRCA1 or BRCA2 mutations treated with olaparib + pembrolizumab compared to olaparib alone as maintenance therapy. SECONDARY OBJECTIVES: I. To evaluate the saf... |
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NRG-CC009: Phase III Trial of Stereotactic Radiosurgery (SRS) versus Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for 10 or fewer Brain Metastases from Small Cell Lung Cancer
Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital PRIMARY OBJECTIVE: I. Determine whether stereotactic radiosurgery (SRS) relative to whole brain radiotherapy with hippocampal avoidance (HA-WBRT) plus memantine hydrochloride (memantine) for brain metastases from small cell lung cancer (SCLC) prevents cognitive function failure as measu... |
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EA8192: A Phase II/III trial of MEDI4736 (Durvalumab) and Chemotherapy for Patients with High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy
Cherry Creek Medical Center, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital PRIMARY OBJECTIVES: I. To compare event-free survival (EFS) between patients with upper tract urothelial cancer (UTUC) randomized to neoadjuvant accelerated methotrexate, vinblastine, adriamycin, cisplatin (aMVAC) alone or in combination with durvalumab. (Cisplatin eligible patients [Ar... |
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Exploring Factors in Patient and Family Consideration of Treatment for Pediatric Central Nervous System Tumors
Childrens Hospital Colorado Interviews will be conducted by a member of the study team at two separate time points. Questions about your treatment and different factors that are important to you when making decisions about your treatment. The interviews will be audio and video recorded by the study team. Only study ... |
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The Intersection of Oncology Care and Worker Well-Being
Grandview Hospital, Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Pikes Peak Regional Hospital, Poudre Valley Hospital, Saint Joseph Hospital, University of Colorado Hospital, Yampa Valley Medical Center You may be eligible for a research study being conducted at the University of Colorado if you are being treated for cancer and were employed when diagnosed. The WeCanWork research study at the University of Colorado Cancer Center is investigating how a new cancer diagnosis impacts wor... |
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A Randomized, Blinded, Placebo-controlled, Phase 2 Study of INBRX-109 in Unresectable or Metastatic Conventional Chondrosarcoma
University of Colorado Hospital This is a randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients. INBRX-109 is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5).... |
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A Phase 1/2, Single-arm Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of Avapritinib in Pediatric Patients with Solid Tumors Dependent on KIT or PDGFRA Signaling
Childrens Hospital Colorado There are two parts planned for this study, the Phase 1 that will test different doses of avapritinib to identify the recommended dose of avapritinib for the Phase 2. The Phase 2 will continue to test this recommended dose of avapritinib to determine if it is a tolerable, safe, and effecti... |
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EA2182: A Randomized Phase II Study of De-Intensified Chemo Radiation for Early Stage Anal Squamous Cell Carcinoma(DECREASE)
Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital PRIMARY OBJECTIVES: I. To determine whether de-intensified chemoradiation for early stage squamous cell carcinoma of the anal canal (SCCA) is able to maintain excellent 2-year disease control of 85% or higher while improving anorectal health-related quality of life (HRQL), compared to s... |
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A Phase 1/2 Study of the Highly Selective ROS1 Inhibitor NVL-520 in Patients with Advanced NSCLC and Other Solid Tumors (ARROS-1)
University of Colorado Hospital In Phase 2, study patients will be enrolled into 5 distinct expansion cohorts: Cohort 2a: ROS1-positive NSCLC naïve to Tyrosine Kinase Inhibitor (TKI) therapy and up to 1 prior chemotherapy and/or immunotherapy; Cohort 2b: ROS1-positive NSCLC treated with 1 prior ROS1 TKI and no prior chem... |
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An Open-label, Dose Escalation and Expansion, Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-500, a Novel Stimulator of Interferon Genes Agonist, as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Select Locally Advanced or Metastatic Solid Tumors
CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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A Phase 1/2, dose escalation, dose expansion, and dose optimization study of the safety, tolerability, and anti-tumor activity of SAR444881 administered alone and in combination with pembrolizumab, cetuximab, and/or chemotherapy in participants with advanced solid tumors
University of Colorado Hospital |
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ARST2031 - A Randomized Phase 3 Trial of Vinorelbine, Dactinomycin, and Cyclophosphamide (VINO-AC) Plus Maintenance Chemotherapy with Vinorelbine and Oral Cyclophosphamide (VINO-CPO) vs Vincristine, Dactinomycin and Cyclophosphamide (VAC) plus VINO-CPO Maintenance in Patients with High Risk Rhabdomyosarcoma (HR-RMS)
Childrens Hospital Colorado |
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PEPN2011: A Phase 1/2 Study of Tegavivint (IND#156033, NSC#826393) in Children, Adolescents, and Young Adults with Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors
Childrens Hospital Colorado For Patients on Part A: D with a solid tumor, lymphoma or desmoid tumor that has either come back or does not respond to therapy, or a desmoid tumor that cannot be removed safely by surgery. For Patients on Part B: Diagnosed with a relapsed or refractory Ewing sarcoma, desmoid tumor, os... |
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A Phase 3 Study of Cretostimogene Grenadenorepvec in Patients with Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)
CTRC Inpatient, University of Colorado Hospital Cohort C(All Countries) : An open-label trial designed to evaluate Cretostimogene + DDM in patients with NMIBC who have failed prior BCG therapy. Single treatment arm that enrolled 115 patients with carcinoma in situ with or without concomitant high-grade Ta or T1 papillary disease B... |
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EA8184: A Phase II Randomized Double Blinded Study of Green Tea Catechins (GTC) vs. Placebo in Men on Active Surveillance for Prostate Cancer: Modulation of Biological and Clinical Intermediate Biomarkers
Cherry Creek Medical Center, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital PRIMARY OBJECTIVE: I. To compare the change in the percent (%) Ki-67 expression in a biopsy core positive for cancer from baseline to end-of-study (EOS) biopsy between men on active surveillance (AS) for prostate cancer (PCa), treated with green tea catechins (GTCs) or placebo for 6 mon... |
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A Phase 1 first in human study evaluating safety, pharmacokinetics and efficacy of ABBV-400 as monotherapy and in combination with bevacizumab in adult subjects with advanced solid tumors
CTRC Inpatient, University of Colorado Hospital ABBV-400 is an investigational drug being developed for the treatment of advanced solid tumors. Study doctors put the participants in groups called treatment arms. The Recommended Phase 2 dose (RP2D) will be explored. Each treatment arm receives a different dose of ABBV-400. This study wil... |
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A Phase II study of induction SBRT and olaparib followed by combination pembrolizumab/olaparib in gastric and gastroesophageal junction (GEJ) cancers
Highlands Ranch Hospital, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital PRIMARY: To assess the anti-tumor efficacy of combined therapy as determined by measurement of objective response rate (ORR) SECONDARY: To assess the anti-tumor efficacy of combined therapy as determined by measurement of overall survival (OS), progression free survival (PFS), duratio... |
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An open-label phase II study to investigate the efficacy, safety, and pharmacokinetics of tirabrutinib in patients with Primary Central Nervous System Lymphoma (PCNSL)
CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital This study will evaluate the efficacy, safety, and pharmacokinetics of tirabrutinib monotherapy in patients with relapsed or refractory PCNSL (Part A), and tirabrutinib in combination with one of two different high dose methotrexate based regimens (methotrexate/ temozolomide/rituximab or r... |
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NRG-BR007: A PHASE III CLINICAL TRIAL EVALUATING DE-ESCALATION OF BREAST RADIATION FOR CONSERVATIVE TREATMENT OF STAGE I, HORMONE SENSITIVE, HER2-NEGATIVE, ONCOTYPE RECURRENCE SCORE <-18 BREAST CANCER
Cherry Creek Medical Center, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital Breast conservation therapy for early stage breast cancer has been an important achievement of oncology practice in the last half century and breast radiotherapy (RT) has been essential in its development. Several seminal randomized clinical trials conducted in the 1980's era demonstrated ... |
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NRG-GU010: PARALLEL PHASE III RANDOMIZED TRIALS OF GENOMIC-RISK STRATIFIED UNFAVORABLE INTERMEDIATE RISK PROSTATE CANCER: DE-INTENSIFICATION AND INTENSIFICATION CLINICAL TRIAL EVALUATION (GUIDANCE)
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 PRIMARY OBJECTIVES: I. To determine whether men with National Comprehensive Cancer Network (NCCN) unfavorable intermediate risk (UIR) prostate cancer and lower Decipher genomic risk (Decipher score < 0.40) treated with radiation therapy (RT) alone instead of 6 months androgen deprivatio... |
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(PEAK) A PHASE 3 RANDOMIZED, OPEN-LABEL, MULTICENTER CLINICAL STUDY OF CGT9486+SUNITINIB VS SUNITINIB IN SUBJECTS WITH LOCALLY ADVANCED, UNRESECTABLE, OR METASTATIC GASTROINTESTINAL STROMAL TUMORS
CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital This study plans to learn more about an investigational drug called bezuclastinib (also known as CGT9486) in combination with sunitinib. “Investigational” means that the study drug has not been approved by the U.S. Food and Drug Administration (FDA). The purpose of this part of the resear... |
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PHASE IB/II CLINICAL TRIAL OF ALPELISIB AND TUCATINIB IN PATIENTS WITH PIK3CA-MUTANT HER2-POSITIVE METASTATIC BREAST CANCER
CTRC Inpatient, Department Specific Free Standing Clinic, LSU Health Sciences Center, Mt. Sinai Comprehensive Cancer Center, University of Colorado Hospital, USD Moores Cancer Center, UW Carbone Cancer Center |
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A PHASE 1 MULTICENTER STUDY EVALUATING THE SAFETY AND TOLERABILITY OF GCC19CART IN SUBJECTS WITH RELAPSED OR REFRACTORY METASTATIC COLORECTAL CANCER (CARAPIA-1 Study)
CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital This study plans to learn more about an investigational drug, GCC19CART. “Investigational” means that the study drug has not been approved by the U.S. Food and Drug Administration (FDA). This research study is a Phase I clinical trial, which tests the safety of an investigational drug an... |
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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
Cherry Creek Medical Center, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital PRIMARY OBJECTIVES: I. To compare overall survival in participants with metastatic urothelial carcinoma (mUC) who are randomized to standard treatment versus eribulin plus gemcitabine hydrochloride (gemcitabine). SECONDARY OBJECTIVES: I. To compare progression-free survival (PFS) ... |
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NRG-GI008: COLON ADJUVANT CHEMOTHERAPY BASED ON EVALUATION OF RESIDUAL DISEASE (CIRCULATE-US)
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 Currently, there are no biomarkers validated prospectively in randomized studies for resected colon cancer to determine need for adjuvant chemotherapy. However, circulating tumor DNA (ctDNA) shed into the bloodstream represents a highly specific and sensitive approach (especially with seri... |
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A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTI TUMOR ACTIVITY OF PF-07799933 (ARRY-440) AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 16 YEARS AND OLDER WITH ADVANCED SOLID TUMORS WITH BRAF ALTERATIONS
CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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Psilocybin-assisted Psychotherapy on Psychiatric and Existential Distress in Advanced Cancer ***Cancer Diagnosis Only***
Department Specific Free Standing Clinic, Outpatient CTRC, University of Colorado Hospital This multi-center trial will enroll 200 participants across two sites. During the randomized, controlled phase of the study, participants will receive either a single 25mg oral ‘high’ dose of psilocybin or an active placebo (100mg niacin), alongside psychotherapy. During the open-label ... |
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A Phase 1b Open-Label Multicenter Study of OP-1250 (Palazestrant) in Combination with the CDK4/6 Inhibitor Ribociclib, with the PI3K Inhibitor Alpelisib, or with the mTOR inhibitor Everolimus in Adult Subjects with Advanced and/or Metastatic ER Positive, HER2 Negative Breast Cancer
CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-F106C as a Single Agent and in Combination with Checkpoint Inhibitors in HLA-A*02:01-Positive Participants with Advanced PRAME-Positive Cancers
CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital The IMC-F106C-101 Phase 1/2 study will be evaluated in patients with metastatic/unresectable tumors which include select Advanced Solid Tumors and will be conducted in two phases. Phase 1: To identify the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 dose (RP2D) of brenetafusp as... |
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A Phase 1b/2 Multicenter, Open-label Study to Evaluate the Safety and Efficacy of TTI-101 as Monotherapy and in Combination in Participants with Locally Advanced or Metastatic, and Unresectable Hepatocellular Carcinoma
CTRC Inpatient, University of Colorado Hospital The primary objectives of Cohort A Phase 1b are to evaluate the safety and tolerability of TTI-101 orally administered as a single agent to participants with locally advanced or metastatic, and unresectable Hepatocellular Carcinoma (HCC) and to determine the maximum tolerated dose (MTD) an... |
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NAUTIKA1: A MULTICENTER, PHASE II, NEOADJUVANT AND ADJUVANT STUDY OF MULTIPLE THERAPIES IN BIOMARKER-SELECTED PATIENTS WITH RESECTABLE STAGES IB-III NON-SMALL CELL LUNG CANCER
Outpatient CTRC, University of Colorado Hospital This trial will evaluate the efficacy and safety of various therapies in patients with Stage IB, IIA, IIB, IIIA, or selected IIIB resectable and untreated non-small cell lung cancer (NSCLC) tumors that meet protocol-specified biomarker criteria.... |
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NRG-BN011, A Phase III Trial of Lomustine-Temozolomide Combination Therapy Versus Standard Temozolomide in Patients With Methylated MGMT Promoter Glioblastoma (NCT 05095376)
Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital |
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EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have Previously Received 2 to 5 years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer with an Increased Risk of Recurrence
Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital |
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Phase II Open Label Multicenter Study of Early REinFusion of Tisagenlecleucel to Promote Durable B-CEll ApLasia in Pediatric and Young Adult Patients with Relapsed/Refractory CD19-Positive B-Cell Acute Lymphoblastic Leukemia (REFUEL)
Childrens Hospital Colorado The primary objective of this phase 2 trial is to decrease the loss of peripheral blood B-cell aplasia (BCA) rate at 6-months post-infusion below 10% (from 26% to 9%) through early reinfusion of tisagenlecleucel in pediatric relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-... |
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A Randomized Phase 3 Study of Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab, with or Without Platinum Chemotherapy, in Subjects with No Prior Therapy for Advanced or Metastatic PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer Without Actionable Genomic
Memorial Hospital Central, Memorial Hospital North |
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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
Rocky Mountain Regional VA Medical Center |
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Developing a Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer: Qualitative Phase
University of Colorado Hospital This study involves interviews with couples facing metastatic colorectal cancer to learn about their experiences and challenges in coping with this disease. From what we learn, we will develop a mindfulness program for couples to lower their stress and help them cope better. ... |
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Autonomic and Renal Contributions to Hypertension with Androgen Deprivation Therapy
Outpatient CTRC We are recruiting individuals with or without prostate cancer to participate in a research study to help us understand how androgen deprivation therapy affects cardiovascular health. Men with prostate cancer will be studied at the start and after 2 months of androgen deprivation therapy. H... |
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A Phase 1 / 2, Open Label, Study of Amivantamab (JNJ-61186372) Among Participants with Advanced NSCLC Harboring ALK, ROS1, and RET Gene Fusions in Combination with Tyrosine Kinase Inhibitors
New York University, Outpatient CTRC, University of Colorado Hospital, University of Michigan, University of Michigan Comprehensive Cancer Center Although non-small cell lung cancer (NSCLC) patients with anaplastic lymphoma kinase (ALK), c-ros oncogene 1(ROS1), and ret proto-oncogene (RET) gene fusions initially respond well to tyrosine kinase inhibitor (TKI) therapies, acquired resistance is inevitable. In many of these cases, incr... |
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EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have Previously Received 2 to 5 years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer with an Increased Risk of Recurrence
Department Specific Study Site - North, Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital |
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EA8212, "A Randomized Phase III Trial of Intravesical BCG veRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naïve High Grade Non-Muscle Invasive Bladder Cancer (BRIDGE)"
University of Colorado Hospital The primary objective of this study is to determine the event free survival (EFS) of BCG-naïve high grade non-muscle invasive bladder cancer patients treated with intravesical BCG vs Gemcitabine + Docetaxel. Secondary objectives are as follows: to compare changes in cancer-specific and bla... |
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Development and Validation of an Ancillary Diagnostic Test for Mycosis Fungoides (SIGNAL-MF)
Department Specific Free Standing Clinic, University of Colorado Hospital Castle Biosciences, Incorporated (CSTL) recently developed and validated a 35-GEP test to aid in the diagnosis of difficult- to-diagnose primary cutaneous melanocytic neoplasms and to improve accuracy when used in combination with currently applied diagnostic tools. Ambiguous lesions repre... |
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Phase 1 study of venetoclax/azacitidine or venetoclax in combination with ziftomenib (KO-539) or standard induction cytarabine/daunorubicin (7+3) chemotherapy in combination with ziftomenib for the treatment of patients with acute myeloid leukemia
CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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S2302: PRAGMATICA - LUNG: A Prospective Randomized Study of Ramucirumab (LY3009806; NSC 749128) plus Pembrolizumab (MK-3475; NSC 776864) versus Standard of Care for Participants Previously Treated with Immunotherapy for Stage IV or
Recurrent Non-Small Cell Lung Cancer
Rocky Mountain Regional VA Medical Center |
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Neoadjuvant Pembrolizumab and Axitinib in Renal Cell Carcinoma with associated Inferior vena cava tumor thrombus (NEOPAX)
University of Colorado Hospital The primary objective of this study is to evaluate whether the combination of Pembrolizumab and Axitinib given in the neoadjuvant setting can decrease the IVC TT burden. A decrease in the size of the tumor thrombus can potentially lead to decrease in surgical complications, improve patie... |
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Phase 3, Open-Label, Randomized, Multi-Center Study of DZD9008 versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor
Receptor Exon 20 Insertion Mutation
CTRC Inpatient, Lone Tree Medical Center, Outpatient CTRC, University of Colorado Hospital This is a phase 3, open-label, randomized, multi-center study assessing the efficacy and safety of DZD9008 versus platinum-based doublet chemotherapy in participants with locally advanced or metastatic NSCLC with EGFR Exon20ins mutation, who are newly diagnosed or have not received prior s... |
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Phase 3, Open-Label, Randomized Study of Datopotamab Deruxtecan with or without Durvalumab Versus Investigator's Choice of Therapy in Patients with Stage I-III Triple Negative Breast Cancer who have Residual Invasive Disease in Breast and/or Axillary Lymph Nodes Following Neoadjuvant Systemic Therapy and Surgical Resection (TROPION-Breast03)
CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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Protocol 10483: Phase Ib trial of Erdafitinib combined with Enfortumab Vedotin following platinum and PD1/L1 inhibitors for metastatic urothelial carcinoma with FGFR2/3 genetic alterations
University of Colorado Hospital PRIMARY OBJECTIVES: I. To determine the feasibility and safety of erdafitinib when combined with enfortumab vedotin (EV) for patients with metastatic urothelial carcinoma (mUC) harboring FGFR2/3 activating genomic alterations who are progressing following platinum-based chemotherapy and... |
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NRG-BR008, "A Phase III Randomized Trial of Radiotherapy Optimization for Low-Risk HER2-Positive Breast Cancer" (HERO)
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 The landmark trials that established breast conservation therapy (BCT) (breast-conserving surgery followed by adjuvant breast irradiation) as a suitable alternative to mastectomy were conducted in an era that predated biological subtyping of breast cancer and the use of HER2-directed thera... |
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S2302, PRAGMATICA - LUNG: A Prospective Randomized Study of Ramucirumab (LY3009806; NSC 749128) Plus Pembrolizumab (MK-3475; NSC 776864) Versus Standard of Care for Participants Previously Treated with Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer
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 This phase III trial compares the effect of the combination of ramucirumab and pembrolizumab versus standard of care chemotherapy for the treatment of non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Ramucirumab is a monoclonal an... |
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A Randomized Open-Label Phase 3 Study of XL092 + Nivolumab vs Sunitinib in Subjects with Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma
Highlands Ranch Hospital, University of Colorado Hospital This study plans to learn more about if an investigational drug called zanzalintinib (XL092) in combination with nivolumab is effective in treating unresectable, locally advanced, or metastatic non-clear cell renal cell carcinoma compared with sunitinib alone among patients who have neve... |
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Protocol S1900G, "A Randomized Phase II Study of Capmatinib plus Osimertinib with or without Ramucirumab in Participants with EGFR-Mutant, MET-Amplified Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)"
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 This phase II Lung-MAP treatment trial test the combination of targeted drugs (capmatinib, osimertinib, and/or ramucirumab) in treating patients with non-small cell lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (adv... |
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Protocol A012103, "OptimICE-pCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy"
Cherry Creek Medical Center, Highlands Ranch Hospital, Lone Tree Medical Center, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital |
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TACTIVE-U: AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL UMBRELLA STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF VEPDEGESTRANT (ARV-471/PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH OTHER ANTICANCER TREATMENTS IN PARTICIPANTS AGED 18 AND OLDER WITH ER+ ADVANCED OR METASTATIC BREAST CANCER, SUB-STUDY C (ARV-471 IN COMBINATION WITH SAMURACICLIB)
Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital |
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TEMPUS SCLC OBSERVATIONAL STUDY: A Tissue and Longitudinal Circulating Tumor DNA (ctDNA) Biomarker Profiling Study of Patients with Small Cell Lung Cancer (SCLC) Using Comprehensive Next-Generation Sequencing (NGS) Assays
Lone Tree Medical Center, University of Colorado Hospital The study is a non-interventional evaluation of participants with SCLC who will receive diagnostic and (where possible) post-progression tumor tissue profiling, alongside plasma ctDNA biomarker profiling in addition to their standard of care therapy and disease surveillance.... |
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Protocol NRG-LU008, "Phase III Prospective Randomized Trial of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed by Concurrent Mediastinal Chemoradiation for Locally Advanced Non-Small Cell Lung Cancer"
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 PRIMARY OBJECTIVES: I. To compare the overall survival in patients with stage II-IIIC inoperable node-positive non-small cell lung cancer (NSCLC) after image guided, motion-managed conventional radiotherapy to the primary tumor and nodal metastases (arm 1) or after image guided, motion-... |
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A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy
Highlands Ranch Hospital, Lone Tree Medical Center, Outpatient CTRC, University of Colorado Hospital |
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ADI-PEG 20 or Placebo Plus Gemcitabine and Docetaxel in Previously Treated Subjects with Leiomyosarcoma (ARGSARC): A Randomized, Double-Blind, Multi-Center Phase 3 Trial
University of Colorado Hospital This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 3 trial that will compare the efficacy and safety in subjects with advanced or metastatic LMS previously treated with an anthracycline.... |
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EMERALD-Y90: Phase II Single-Arm Study of Durvalumab and Bevacizumab Following Transarterial Radioembolization Using Yttrium-90 Glass Microspheres (TheraSphere) in Unresectable Hepatocellular Carcinoma Amenable to Locoregional Therapy
University of Colorado Hospital A Phase II single-arm study conducted in participants with unresectable Hepatocellular carcinoma (HCC) eligible for embolization and not eligible for or who have declined treatment with resection and/or ablation or liver transplant. Participants with previous Transarterial Chemoemboliza... |
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An Open-Label, Phase II, Randomized, Controlled Study of Danvatirsen Plus Pembrolizumab Compared to Pembrolizumab Alone in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
CTRC Inpatient, Highlands Ranch Hospital, University of Colorado Hospital Open-label, Phase II, randomized, controlled study evaluating the efficacy and safety of danvatirsen in combination with pembrolizumab compared with pembrolizumab alone as first-line treatment of patients with recurrent/metastatic (R/M) HNSCC. Two-thirds of patients will be randomized to r... |
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A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined with JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer
CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital You are being asked to be in this research study because you have metastatic castration-resistant prostate cancer (mCRPC). This study plans to learn more about whether JNJ-87189401 given in combination with JNJ78278343 in patients with mCRPC can cause side effects, and to find doses of th... |
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A PHASE 3, OPEN-LABEL STUDY OF ELRANATAMAB MONOTHERAPY VERSUS ELOTUZUMAB, POMALIDOMIDE, DEXAMETHASONE (EPd) OR POMALIDOMIDE, BORTEZOMIB, DEXAMETHASONE (PVd) OR CARFILZOMIB, DEXAMETHASONE (Kd) IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO RECEIVED PRIOR ANTI-CD38 DIRECTED THERAPY
Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital |
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A PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF OP-1250 MONOTHERAPY VS STANDARD OF CARE FOR THE TREATMENT OF ER+, HER2- ADVANCED OR METASTATIC BREAST CANCER FOLLOWING ENDOCRINE AND CDK 4/6 INHIBITOR THERAPY (OPERA-01)
Cherry Creek Medical Center, CTRC Inpatient, Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital |
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A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With Resected Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer (INTerpath-002)
Memorial Hospital Central, Memorial Hospital North |
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Protocol CCTG-NE.1 "NET RETREAT: A phase II study of 177Lutetium-DOTATATE retreatment vs. everolimus in metastatic/unresectable midgut NET"
University of Colorado Hospital PRIMARY OBJECTIVE: I. To evaluate the effect of lutetium Lu 177 dotatate (177Lu-DOTATATE) versus (vs.) everolimus on progression-free survival (PFS) in patients with metastatic/unresectable midgut neuroendocrine tumour (NET) who have progressed following previous peptide receptor radion... |
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Improving patient-centered Ob-Gyn care for Black women: Co-designing solutions to mitigate systemic racism, discrimination and bias
Department Specific Free Standing Clinic, University of Colorado Hospital CU OB-Gyn providers are committed to addressing racial inequities in healthcare. We invite patients, advocates and members of the community who identify as Black, African American, African, Afro-Latinx or Afro-Caribbean to share your experiences and feedback, especially those that have rec... |
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BfedBwell: A Nutrition Program for Cancer Survivors with Overweight or Obesity
Anschutz Health and Wellness, Outpatient CTRC If you decide to be in the study, you will participate in the BfedBwell survivorship nutrition program for 6 months. The BfedBwell program has group education sessions and none, some, or all of the following: group support sessions, cooking demonstrations, and/or 1-on-1 counseling with a d... |
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A Phase 3 Randomized, Controlled Study of IMC-F106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants With Previously Untreated Advanced Melanoma (PRISM-MEL-301)
CTRC Inpatient, University of Colorado Hospital You are being asked to be in this research study because you are an adult with advanced melanoma (a kind of skin cancer) that has spread or cannot be surgically removed. This study includes participants with advanced melanoma from any part of the body except the eye. This study plans to... |
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An open-label phase 1 study to investigate PF-08046050 (SGN-CEACAM5C) in adults with advanced solid tumors
University of Colorado Hospital This study plans to learn more about the investigational drug PF-0804650 to find out what its side effects are and if it works for solid tumor cancer. A side effect is anything the drug does to your body besides treating your disease. If you have side effects, your study doctor may prescr... |
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Phase I open-label, dose escalation trial of BI 1831169 monotherapy and in combination with an anti-PD-1 mAb in patients with advanced or metastatic solid tumors.
CTRC Inpatient, University of Colorado Hospital Part 1 of this study plans to learn more about: To find the recommended dose of the study drug, BI 1831169, that can be used in Part 2 of this study. This will be done by testing different doses of the study drug to see which dose has less unacceptable side effects in subjects with soli... |
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A Study Evaluating an Intermittent Fasting Intervention in Adults with Breast Cancer and Overweight or Obesity
Anschutz Health and Wellness, Outpatient CTRC, University of Colorado Hospital If you decide to participate in the study, you will be on an intermittent fasting diet three days per week to reduce what you are eating for 6 months. On the intermittent fasting diet days, you will only eat about 500 calories per day. On the other four non-fasting diet days per week, you ... |
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A Phase III, Randomized, Open-Label, Multi-Center, Global Study of Volrustomig (MEDI5752) as Sequential Therapy Versus Observation in Participants with Unresected Locally Advanced
Head and Neck Squamous Cell Carcinoma, Who Have Not Progressed Following Definitive Concurrent Chemoradiotherapy (eVOLVE-HNSCC)
Highlands Ranch Hospital, Outpatient CTRC, University of Colorado Hospital The main purpose of this study is to assess the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not progressed after receiving definitive concurrent chemoradiotherapy (cCRT... |
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The time course of the therapeutic influence of a single exercise bout on cancer-related fatigue
Harmony Campus This study plans to learn more about cancer related fatigue changes from before to immediately after a single exercise session. In addition, we want to assess the changes in fatigue levels following a single exercise session at various time intervals over the course of a day. Finally, we w... |
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Protocol S2210, "A Phase II Study of Neoadjuvant Carboplatin for Localized, High Risk Localized Prostate Cancer with Germline BRCA1/2 Mutations," NCT# 05806515
Lone Tree Medical Center, University of Colorado Hospital PRIMARY OBJECTIVE: I. To evaluate the pathologic complete response rate at prostatectomy in patients with localized high-risk prostate cancer with germline BRCA2 or BRCA1 mutations who are treated with neoadjuvant carboplatin by central review of source documents. SECONDARY OBJECTIVE... |
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AALL2121: A Phase 2 Study of Revumenib (SNDX-5613) in Combination with Chemotherapy for Patients with Relapsed or Refractory KMT2A-Rearranged infant Leukemia
Childrens Hospital Colorado A Phase 2 study of SNDX-5613 in combination with chemotherapy for patients with relapsed or refractory KMT2A-rearranged infant leukemia... |
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Protocol EA2222 - A Randomized Phase III Study of Systemic Therapy With or Without Hepatic Arterial Infusion for Unresectable Colorectal Liver Metastases: The PUMP Trial
University of Colorado Hospital PRIMARY OBJECTIVE: I. To determine if patients with persistently unresectable colorectal liver metastases (CRLM) after treatment with first-line chemotherapy have improved overall survival (OS) with hepatic arterial infusion (HAI) and systemic chemotherapy versus systemic chemotherapy a... |
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A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Previously Untreated Triple Negative or Hormone Receptor-low/HER2-negative Breast Cancer (D926QC00001; TROPION-Breast04)
Cherry Creek Medical Center, CTRC Inpatient, Highlands Ranch Hospital, Lone Tree Medical Center, Outpatient CTRC, University of Colorado Hospital |
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A Phase 1, Safety Lead-In and Randomized, Open-label, Perioperative Study of Vorasidenib in Combination with Pembrolizumab in Subjects with Recurrent or Progressive IDH-1 Mutant Glioma
CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital The study is divided into 2 phases, a Safety Lead-In phase and a randomized perioperative phase. In the Safety Lead-In Phase, the recommended combination dose (RCD) of vorasidenib will be determined. In the Randomized Perioperative Phase, the Lymphocytes infiltration in tumors will be eval... |
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A Phase I/II Study of M3814 and Avelumab in Combination with Hypofractionated Radiation in Patients with Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies
University of Colorado Hospital PRIMARY OBJECTIVES: I. To determine the safety and tolerability and recommended phase 2 dose (RP2D) of peposertib (M3814) in combination with hypofractionated radiation and avelumab in patients with advanced/metastatic solid tumors. (Phase I) II. To determine the efficacy of the combina... |
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EA8211: A Phase III Randomized Trial of Stereotactic ablative radiotherapy (SAbR) for Oligometastatic Advanced Renal Carcinoma (SOAR)
Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital PRIMARY OBJECTIVES: I. To compare overall survival (OS) between patients receiving SAbR + systemic therapy (SABR+ST) versus systemic therapy (ST) only. II. To compare average adverse event (AE) score between SAbR+ST arm and ST only arm. SECONDARY OBJECTIVES: I. To compare globa... |
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Protocol NRG-BR009, A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression plus Endocrine Therapy in Premenopausal Patients with pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score less than or equal to 25 (OFSET)
Cherry Creek Medical Center, Highlands Ranch Hospital, Lone Tree Medical Center, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital |
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IDE196 (DAROVASERTIB) IN COMBINATION WITH CRIZOTINIB VERSUS INVESTIGATOR'S CHOICE OF TREATMENT AS FIRST-LINE THERAPY IN HLA-A2 NEGATIVE METASTATIC UVEAL MELANOMA (DAR-UM-2)
CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital This study plans to learn more about if the investigational drug called IDE196 (also called darovasertib) in combination with crizotinib is safe and effective in people who have a cancer in their eye, called uveal melanoma, which has now spread (metastasized) to another part of your body... |
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Molecular Analysis for Combination Therapy Choice (ComboMATCH) Protocol EAY191-A3, A ComboMATCH Treatment Trial: Palbociclib and Binimetinib in RAS-Mutant Cancers (NCT05554367)
Greeley Campus, Harmony Campus, Medical Center of the Rockies, Outpatient CTRC, Poudre Valley Hospital, University of Colorado Hospital |
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A Phase III, Randomized, Open-Label, Multicenter, Global Study of Volrustomig (MEDI5752) in Combination with Carboplatin plus Pemetrexed Versus Platinum plus Pemetrexed or Nivolumab plus Ipilimumab in Participants with Unresectable Pleural Mesothelioma (eVOLVE-Meso)
Outpatient CTRC, University of Colorado Hospital Adult patients with histologically proven diagnosis of pleural mesothelioma with advanced unresectable disease are eligible to be enrolled. Patients will be randomized 1:1 to receive Volrustomig (MEDI5752) + Carboplatin + Pemetrexed or the investigator's choice of platinum+Pemetrexed or Ni... |
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S2206: Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) plus Chemotherapy versus Chemotherapy Alone for Adults with MammaPrint Ultrahigh (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer,
Cherry Creek Medical Center, Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital |
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A Phase 1b study of Psilocybin Assisted Psychotherapy to address fear of recurrence in patients diagnosed with early-stage breast cancer and ovarian cancer in remission
Outpatient CTRC, University of Colorado Hospital A study conducted to determine if a single dose of 25 mg. of psilocybin, in combination with therapy, will address fear of recurrence in patients diagnosed with early-stage breast cancer and ovarian cancer in remission... |
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Protocol S1900K, "A Randomized Phase II Study of Tepotinib with or without Ramucirumab in Participants with MET Exon 14 Skipping Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)"
Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital This phase II Expanded Lung-MAP treatment trial tests tepotinib with or without ramucirumab for the treatment of patients with advanced non-small cell lung cancer that has spread from where it first started (primary site) to other places in the body (stage IV) or that has come back after a... |
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Protocol 10608, "A phase II trial of durvalumab with gemcitabine and cisplatin as neoadjuvant therapy for high-risk resectable intrahepatic cholangiocarcinoma" (NCT TBD)
University of Colorado Hospital PRIMARY OBJECTIVE: I. To examine the proportion of patients who complete neoadjuvant therapy followed by curative intent surgical resection. SECONDARY OBJECTIVES: I. To determine the major pathologic response (MPR) rate. (Efficacy) II. To determine the proportion of patients who a... |
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A Phase 1b/2, Open-label Study of Amivantamab Monotherapy and Amivantamab in Addition to
Standard of Care Therapeutic Agents in Participants with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
CTRC Inpatient, University of Colorado Hospital The purpose of this study is to determine safety and preliminary efficacy of amivantamab monotherapy, amivantamab in addition to pembrolizumab, and amivantamab in addition to paclitaxel in participants with recurrent/metastatic head and neck cancer. The study will also confirm the recommen... |
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A Phase 1b, Open-Label, Safety, Tolerability, and Efficacy Study of HC-7366 in Combination with Belzutifan (WELIREGTM) in Patients with Locally Advanced (Inoperable) or Metastatic Renal Cell Carcinoma
CTRC Inpatient, Highlands Ranch Hospital, Outpatient CTRC, University of Colorado Hospital This study plans to learn more about and identify the highest safe dose (called the maximum tolerated dose and/ or recommended dose) of the study drug HC-7366 and Belzutifan (also known as MK-6482) for the next phase of testing (called the recommended Phase 2 dose). The study aims to under... |
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Protocol A032103, "MODERN: An Integrated Phase 2/3 and Phase 3 Trial of MRD-Based Optimization of Adjuvant Therapy in Urothelial Cancer"
Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital PRIMARY OBJECTIVES: I. To compare the ctDNA clearance proportion (i.e., ctDNA positive [+] --> ctDNA negative [-]) at 12 weeks in patients enrolled in Cohort A treated with adjuvant nivolumab versus nivolumab + relatlimab (phase 2 portion). II. To compare overall survival in patients... |
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Lynch syndrome INtegrative Epidemiology And GEnetics (LINEAGE) Consortium
University of Colorado Hospital The purpose of this consortium is to establish a cohort of LS patients with systematic collection of cancer risk factors, adherence to risk reduction care, and quality of colonoscopic surveillance to estimate the rates of prevalent and incident cancers in LS, and patient-, provider- and sy... |
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A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Global Study of Rilvegostomig in Combination With
Chemotherapy as Adjuvant Treatment After Resection of Biliary Tract Cancer With Curative Intent (ARTEMIDE-Biliary01)
Cherry Creek Medical Center, Highlands Ranch Hospital, Outpatient CTRC, University of Colorado Hospital This is a Phase III, randomized, double-blind, placebo-controlled, multicenter, global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy (capecitabine, S-1(tegafur/ gimeracil/ oteracil) or gemcitabin... |