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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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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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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 PRIMARY OBJECTIVE: I. To compare breast cancer event-free survival between participants randomized to standard of care neoadjuvant chemotherapy alone versus standard of care neoadjuvant chemotherapy concurrent with durvalumab. SECONDARY OBJECTIVES: I. To compare pathologic complet... |
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A Phase 3, Randomized, Multi-center, Open-label Study of DB-1303 Versus Investigator's Choice Chemotherapy in Human Epidermal Growth Factor Receptor 2 (HER2)-low, Hormone Receptor Positive (HR+) Metastatic Breast Cancer Patients whose Disease has Progressed on Endocrine Therapy (ET) (DYNASTY-Breast02)
Cherry Creek Medical Center, CTRC Inpatient, Highlands Ranch Hospital, Lone Tree Medical Center, Outpatient CTRC, University of Colorado Hospital The study is a Phase III, Randomized, Multi-center, Open-label study in HER2-low, HR+ metastatic breast cancer subjects whose disease has progressed on at least 2 lines of prior ET or within 6 months of first line ET + Cyclin-dependent kinase (CDK) 4/6 inhibitor in the metastatic setting. ... |
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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 Younger age at diagnosis is an adverse prognostic factor in early breast cancer: women who are less than 35 years of age at diagnosis are more likely to die from their disease than their older counterparts following standard treatments. There remains a pressing need for advancements in the... |
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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 The primary objectives of the study are to demonstrate superiority of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy relative to neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in... |
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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 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 This is an international, multicenter, randomized, open-label, active-controlled, phase 3 clinical trial. The purpose of this trial is to compare the safety and efficacy of palazestrant (OP-1250) as a single agent to the standard of care endocrine therapy: either fulvestrant or an aromatas... |
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Breast Cancer-Minimal/Molecular Residual Disease Detection and Therapy Monitoring in Patients with Early Stage TNBC-Phase I (B-STRONGER-I)
University of Colorado Hospital NeXT Personal CTA (Clinical Trial Assay) is a patient-specific, tumor-informed device which allows for detection of MRD from cfDNA. By using next generation sequencing technology, whole genome sequencing (WGS) is conducted from DNA derived from patient tumor and normal samples. A tumor inf... |
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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 You are being asked to be in this research study because you have high-risk early triplenegative breast cancer (TNBC) without mutations in the BRCA1 or BRCA2 gene. For this study high-risk early TNBC is defined as any presence of TNBC that still remains in the breast or lymph node tissue a... |
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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 PRIMARY OBJECTIVES: I. To evaluate whether observation results in a non-inferior recurrence-free survival (RFS) compared to adjuvant pembrolizumab in early-stage triple-negative breast cancer (TNBC) patients who achieve a pathologic complete response (pCR) after neoadjuvant chemotherapy... |
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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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ELACESTRANT in Women and Men with CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer: An Open-Label Multicenter Phase 2 Study (ELCIN)
University of Colorado Hospital This is a Phase 2 trial evaluating the efficacy of elacestrant in patients with ER+/HER2- advanced/metastatic breast cancer who received one or two prior hormonal therapies and no prior CDK4/6i in the metastatic setting. The study duration for each patient is estimated to be: Screeni... |
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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 The study will investigate the efficacy and safety of Dato-DXd with or without durvalumab when compared with ICT (capecitabine and/or pembrolizumab) in participants with stage I to III TNBC who have residual invasive disease in the breast and/or axillary lymph nodes at surgical resection f... |
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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 This study plans to learn more about how safe an investigational drug known as imlunestrant is and how well it will work to help people with Estrogen receptor positive (ER+), human epidermal growth factor receptor 2-negative (HER2-), early breast cancer with an increased risk of recurrenc... |
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A Phase II Study of the safety, tolerability and antitumor activity of tucatinib in combination with eribulin and trastuzumab in patients with pretreated unresectable locally advanced or metastatic HER2+ breast cancer
Outpatient CTRC, University of Colorado Hospital In view of the potency of tucatinib for the treatment of brain metastases and its modest toxicity, it is important to evaluate the combination of this drug with other established anti-HER2 therapies. There remains a need to evaluate the efficacy of tucatinib with additional active agents i... |
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Phase 1/2 Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants with Advanced Solid Tumors
CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital The main purpose of this study is to test how safe these drugs are, and how well the body deals with effects of mRNA-4359 when it is given alone or in combination with pembrolizumab. The goal is to find a safe and acceptable dose in people with locally advanced, metastatic, or relapsed can... |
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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 Part 1 (Dose Escalation): This part will evaluate the safety and pharmacokinetics of a range of doses of OP-1250 administered orally (PO) daily to subjects in combination with 600 mg of ribociclib administered PO daily for 21 consecutive days followed by 7 days off treatment (Treatment Gro... |
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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 This study is a multicenter, single arm, open-label, run-in phase Ib safety cohort with immediate roll over to a phase II clinical trial that will test the combination therapy of tucatinib with alpelisib in subjects with PIK3CA-mutant HER2+ locally advanced unresectable or metastatic breas... |
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A Phase 1 Study of SGN-B7H4V in Advanced Solid Tumors
CTRC Inpatient, University of Colorado Hospital The study will have 5 parts: Parts A and B of the study will find out how much SGN-B7H4V should be given to participants. Part C will use the amount found in Parts A and B to find out how safe SGN-B7H4V is and if it works to treat solid tumor cancers. Part D will find out if and how m... |
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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 The drug being tested in this study is called TAK-500. The study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of TAK-500 when used as a single agent (SA) and in combination with pembrolizumab in participants with locall... |
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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 This Phase Ib/III study (CAPItello-292) aims to evaluate the efficacy, safety and the degree of added benefit of capivasertib combined with CDK4/6i and fulvestrant in participants with locally advanced (inoperable) or metastatic HR+/HER2- breast cancer. Although the dosing regimens of capi... |
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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 PRIMARY OBJECTIVE: I. To determine if the invasive disease-free survival (iDFS) with T-DM1 and tucatinib is superior to the iDFS in the control arm (T-DM1 + placebo) when administered to high risk patients with HER2-positive breast cancer and residual disease after neoadjuvant HER2-dire... |
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A RANDOMIZED, PHASE II TRIAL OF CIRCULATING TUMOR DNA-GUIDED SECOND LINE ADJUVANT THERAPY FOR HIGH RESIDUAL RISK, ESTROGEN RECEPTOR POSITIVE, HER2 NEGATIVE BREAST CANCER (DARE)
Cherry Creek Medical Center, Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital Surveillance population and ctDNA screening (up to 1000 patients): Clinically high risk, stage II-III, ER positive, HER2-, breast cancer patients who are currently receiving adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen are eligible for ctDNA screening if they meet an... |
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MammaPrint, BluePrint, and Full-genome Data Linked with Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX Registry)
Cherry Creek Medical Center, Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital The FLEX Registry will include all patients with stage I-III breast cancer who have received MammaPrint and BluePrint testing in any clinical setting. Study arm appendices will specify treatment arm, inclusion criteria, and number of patients needed. Approximately 30,000 patients from 125+... |
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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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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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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 You are being asked to be in this research study because you have an advanced tumor with the PI3KαH1047R mutation or breast cancer with the PI3KαH1047R mutation. OnKure has begun a study of an investigational drug called OKI-219 as a possible treatment for people who have cancer due to ... |
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A211801, "BRCA-P: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, International Phase 3 Study to Determine the Preventive Effect of Denosumab on Breast Cancer in Women Carrying a BRCA1 Germline Mutation,"
University of Colorado Hospital PRIMARY OBJECTIVE: I. To evaluate the reduction in the risk of any breast cancer (invasive or ductal carcinoma in situ [DCIS]) in women with germline BRCA1 mutation who are treated with denosumab compared to placebo. SECONDARY OBJECTIVES: I. To determine the reduction in the risk ... |
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First-in-Human Study of STX-478, a Mutant Selective PI3K alpha Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumor
CTRC Inpatient, University of Colorado Hospital Part 1 will study STX-478 as monotherapy in participants with advanced solid tumors. Part 2 will study STX-478 therapy as combination therapy with fulvestrant in participants with hormone receptor positive (HR+) breast cancer. Part 3 will evaluate STX-478 as combination therapy with fulves... |
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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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NRG-GI008: COLON ADJUVANT CHEMOTHERAPY BASED ON EVALUATION OF RESIDUAL DISEASE (CIRCULATE-US)
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...more > Protocol #22-0916 Location: 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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Lynch syndrome INtegrative Epidemiology And GEnetics (LINEAGE) Consortium
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...more > Protocol #24-0857 Location: University of Colorado Hospital |
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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)
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 ...more > Protocol #22-2363 Location: Highlands Ranch Hospital, University of Colorado Hospital |
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A Phase 1, First-in-Human, Open-Label, Dose-Escalation and Expansion Study of IMGN151 (anti-FRa antibody-drug conjugate) in Adult Patients with Recurrent Gynecological Cancers
This Phase 1 study is designed to characterize the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of IMGN151 in patients with recurrent endometrial cancer, or recurrent, high-grade serous epithelial ovarian cancer, primary peritoneal, or fallopian tube cancers...more > Protocol #22-1835 Location: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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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)"
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...more > Protocol #24-0486 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital |
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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)"
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...more > Protocol #23-0936 Location: 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 |
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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)
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) ...more > Protocol #19-0267 Location: 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 Randomized, Pragmatic, Adaptive trial of Metformin for Glucose Intolerance or Increased Body Mass Index in Prostate Cancer Patients
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...more > Protocol #19-1536 Location: 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 |
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GS-US-682-6769/GOG-3104/ENGOT-en26: A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy
Researchers are looking for new ways to treat people with endometrial cancer (EC) who have previously received treatment with platinum based therapy (a type of chemotherapy) and immunotherapy. Immunotherapy is a treatment that helps the immune system fight cancer. This clinical study will ...more > Protocol #24-1498 Location: Highlands Ranch Hospital, 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
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...more > Protocol #23-0867 Location: 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 |
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Genetic Engagement, Education, and Screening (CU-GENES) Study
This study plans to implement a community-based genetic testing program for hereditary cancer risk in a higher risk population. The study team will partner with the Colorado Ovarian Cancer Alliance (COCA) and the Jewish Community Center (JCC) to provide educational events to the Jewish com...more > Protocol #23-0584 Location: Department Specific Free Standing Clinic, University of Colorado 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)"
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...more > Protocol #23-0074 Location: University of Colorado Hospital |
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Autonomic and Renal Contributions to Hypertension with Androgen Deprivation Therapy
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...more > Protocol #22-2201 Location: Outpatient CTRC |
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The Intersection of Oncology Care and Worker Well-Being
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...more > Protocol #21-4139 Location: 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 |
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A Phase 1, Open-label, Multicenter Study of ZW171 in Participants With Advanced or Metastatic Ovarian Cancer, Non-small Cell Lung Cancer (NSCLC), and Other Mesothelin Expressing Cancers
This study is being done to find out if ZW171 is safe and can treat participants with advanced (locally advanced [inoperable] and/or metastatic) mesothelin-expressing cancers....more > Protocol #24-1477 Location: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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A Phase 1a/b Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Patients With Solid Malignancies
This study will learn more about the study drug GS-9716 given alone or in combination with other anti-cancer agents in patients with advanced solid tumors....more > Protocol #23-2253 Location: CTRC Inpatient, University of Colorado Hospital |
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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
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...more > Protocol #22-1450 Location: New York University, Outpatient CTRC, University of Colorado Hospital, University of Michigan, University of Michigan Comprehensive Cancer Center |
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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,"
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) ...more > Protocol #23-0845 Location: University of Colorado Hospital |
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Head and Neck Cancer Tissue Bank
The purpose of this study is to collect tissue from patients that have undergone or will undergo workup or treatment for HNSCC or SGC...more > Protocol #08-0552 Location: Highlands Ranch Hospital, University of Colorado Hospital |
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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*)
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...more > Protocol #21-2970 Location: 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 |
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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
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...more > Protocol #19-0642 Location: University of Colorado Hospital |
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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.
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...more > Protocol #18-1651 Location: University of Colorado Hospital |
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ORACLE: Observation of ResiduAl Cancer with Liquid Biopsy Evaluation
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...more > Protocol #22-0526 Location: University of Colorado Hospital |
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Psilocybin-assisted Psychotherapy on Psychiatric and Existential Distress in Advanced Cancer ***Cancer Diagnosis Only***
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 ...more > Protocol #22-1207 Location: Department Specific Free Standing Clinic, Outpatient CTRC, University of Colorado Hospital |
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Perspectives on Cancer Screening in the Sexual and Gender Minority Community
The purpose of this study is to understand the LGBTQ+ community's knowledge, attitudes and behaviors on cancer screenings. Study participation involves a brief survey and a short interview. Participants will be compensated with $100 for their time and effort. ...more > Protocol #24-2012 Location: Department Specific Free Standing Clinic, University of Colorado Hospital |
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Detection of Colorectal Cancer or Advanced Neoplasia by Stool DNA in Lynch Syndrome: CORAL Study
The purpose of this research is to determine a new approach for non-invasive screening and early detection of Colorectal Cancer or Advanced Neoplasia in patients with Lynch syndrome. Participation in this study includes one time stool collection and an optional blood colletion. ...more > Protocol #24-0824 Location: University of Colorado Hospital |
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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
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...more > Protocol #24-0472 Location: CTRC Inpatient, University of Colorado Hospital |
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The time course of the therapeutic influence of a single exercise bout on cancer-related fatigue
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...more > Protocol #23-1789 Location: Harmony Campus |
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FONTANA: A Modular Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Ascending Doses of AZD5335 Monotherapy and in Combination with Anti-cancer Agents in Participants with Solid Tumors
This study is a Phase I/IIa modular, open-label, multi-center study of AZD5335 administered either as monotherapy or in combination with other anti-cancer agents in participants with advanced solid malignancies...more > Protocol #23-2128 Location: CTRC Inpatient, University of Colorado Hospital |
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A Phase 1a, Dose Escalation, Safety and Tolerability Study of NX-1607, a Casitas B-lineage lymphoma proto-oncogene (CBL-B) inhibitor, in Adults with Advanced Malignancies, with Phase 1b Expansion in Select Tumor Types
This study is being done to see if NX-1607 is safe and tolerated, and to find the highest does that can safely be given. The study will also look at whether NX-1607 has an effect on the cancers being studied....more > Protocol #23-1337 Location: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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Developing a Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer: Qualitative Phase
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. ...more > Protocol #22-2246 Location: University of Colorado Hospital |
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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
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....more > Protocol #22-1484 Location: Outpatient CTRC, 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)
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...more > Protocol #21-2992 Location: Outpatient CTRC, University of Colorado Hospital |
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The Lung PCA: A Multi-Dimensional Atlas of Pulmonary Premalignancy
This protocol pertains specifically to the prospective lung squamous cell carcinoma pre-malignant lesion (PML) cohort that will form a primary study group for the Lung Pre-Cancer Atlas. Via pre-screening, veteran and non-veteran subjects at high risk for the development of lung squamous c...more > Protocol #19-0400 Location: Rocky Mountain Regional VA Medical Center, University of Colorado Hospital |
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Alliance Protocol A212102, "Blinded Reference Set for Multicancer Early Detection Blood Tests
PRIMARY OBJECTIVE: I. To provide a blinded reference set of cancer versus (vs.) non-cancer blood samples that will be used to validate assays for inclusion in a prospective clinical trial focused on utility of blood-based multi-cancer early detection. SECONDARY OBJECTIVES: I. Eval...more > Protocol #23-1087 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital, Yampa Valley Medical Center |
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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.
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...more > Protocol #22-2372 Location: CU-RIC, University of Colorado Hospital |
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EA8134: InPACT- International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)
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...more > Protocol #17-1515 Location: University of Colorado Hospital |
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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
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...more > Protocol #21-4711 Location: Cherry Creek Medical Center, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital |
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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
This study is seeking participants who have an advanced solid tumor with a certain type of abnormal gene called "BRAF" and available treatments are no longer effective in controlling their cancer. All participants in this study will receive PF-07799933. PF-07799933 comes as a tablet to ...more > Protocol #22-1125 Location: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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Open Label, Multicenter, Phase 1 Study to Evaluate the Maximum Tolerated Dose of Orally Administered CB-03-10 with Dose Expansion Phase, in Subjects with Advanced Solid Tumors
This study has 2 parts. Part 1 is also called Dose Escalation. During Part 1 groups of patients with cancer, also known as cohorts, will take different doses of the study drug and be followed closely. At the end of the Part 1 of the study, we will see what dose of the study drug is tolera...more > Protocol #22-0877 Location: CTRC Inpatient, University of Colorado Hospital |
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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
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...more > Protocol #24-0745 Location: CTRC Inpatient, Highlands Ranch Hospital, Outpatient CTRC, University of Colorado Hospital |
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A Phase 1 Clinical Study of NXP800 in Subjects With Advanced Cancers and Expansion in Subjects with Ovarian Cancer (NXP800-101; ENGOTGYN5/ NCRI/NXP800-101; GOG-3087)
Part A of the study is a dose escalation by cohort study of NXP800 administered to patients with advanced cancers. The study will identify the maximum tolerated dose (MTD) and propose dose and dose schedules for future studies. In Part B doses selected in Part A are administered to pati...more > Protocol #23-0966 Location: CTRC Inpatient, University of Colorado Hospital |
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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
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...more > Protocol #21-4822 Location: CTRC Inpatient, University of Colorado Hospital |
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Protocol 10505, A phase 1 and randomized phase 2 trial of selinexor and temozolomide in recurrent glioblastoma
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...more > Protocol #23-0099 Location: University of Colorado Hospital |
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BfedBwell: A Nutrition Program for Cancer Survivors with Overweight or Obesity
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...more > Protocol #23-2151 Location: Anschutz Health and Wellness, Outpatient CTRC |
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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)
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...more > Protocol #19-0967 Location: University of Colorado Hospital |
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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)
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...more > Protocol #22-0504 Location: 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 |
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An open-label phase 1 study to investigate PF-08046050 (SGN-CEACAM5C) in adults with advanced solid tumors
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...more > Protocol #23-2329 Location: University of Colorado Hospital |
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A PHASE 1 STUDY OF TJ033721 IN SUBJECTS WITH ADVANCED OR METASTATIC SOLID TUMORS
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...more > Protocol #21-3254 Location: Outpatient CTRC, University of Colorado Hospital |
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Human Trisome Project
Additional information about this study can be found at www.trisome.org....more > Protocol #15-2170 Location: Childrens Hospital Colorado, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital |
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A Phase III Randomized Trial of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Cisplatin versus no HIPEC at the Time of Interval Cytoreductive Surgery followed by Niraparib Maintenance in Patients with Newly Diagnosed Stage III and IV Ovarian, Primary Peritoneal, and Fallopian Tube Cancer (Hyperthermic Ovarian Treatment Trial)
This study plans to learn more about if giving heated chemotherapy into the belly, known as heated intraperitoneal chemotherapy (HIPEC), improves the treatment of your type of cancer. You are being asked to be in this research study because you have newly diagnosed ovarian, primary peri...more > Protocol #23-2189 Location: University of Colorado Hospital |
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A PHASE 1b STUDY OF ZN-c3 IN COMBINATION WITH CHEMOTHERAPY OR BEVACIZUMAB IN SUBJECTS WITH OVARIAN, PERITONEAL, OR FALLOPIAN TUBE CANCER
This study plans to learn more about an investigational drug called ZN-c3 (also known as azenosertib; KP-2638). Investigational means that the study drug has not been approved by the U.S. Food and Drug Administration (FDA). ZN-c3 may be called the study drug. The purpose of this study in...more > Protocol #22-0890 Location: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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NRG-GY026, "A Phase II/III study of paclitaxel/carboplatin alone or combined with either trastuzumab and hyaluronidase-oysk (HERCEPTIN HYLECTA) or pertuzumab trastuzumab and hyaluronidase-zzfx (PHESGO) in HER2 positive, stage I-IV endometrial serous carcinoma or carcinosarcoma," (#NCT05256225)
PRIMARY OBJECTIVES: I. To evaluate the efficacy of trastuzumab and hyaluronidase-oysk (HERCEPTIN HYLECTA) and pertuzumab, trastuzumab, and hyaluronidase-zzxf (PHESGO) in combination with paclitaxel/carboplatin in patients with HER2 positive endometrial cancer. (Phase II) II. To evaluate...more > Protocol #22-1764 Location: Cherry Creek Medical Center, Highlands Ranch Hospital, Outpatient CTRC, University of Colorado Hospital |
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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
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...more > Protocol #18-2252 Location: 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 |
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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)
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...more > Protocol #22-0175 Location: 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 |
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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
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...more > Protocol #23-1990 Location: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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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
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...more > Protocol #20-3065 Location: Childrens Hospital Colorado |
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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)
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...more > Protocol #22-0697 Location: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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CCTG EN.10/NRG-GY032: A PHASE II STUDY OF TAILORED ADJUVANT THERAPY IN POLE-MUTATED AND p53-WILDTYPE/NSMP EARLY STAGE ENDOMETRIAL CANCER (RAINBO BLUE & TAPER)
SUBSTUDY A: RAINBO POLEmut-BLUE: Refining Adjuvant treatment IN endometrial cancer Based On molecular features (RAINBO) TransPORTEC platform trials
SUBSTUDY B: Tailored Adjuvant Therapy in p53-Wildtype/NSMP Early Stage Endometrial Cancer (TAPER)
PRIMARY OBJECTIVE: I. Estimate the rate of pelvic recurrence at 3 years in patients who are treated with a de-escalated adjuvant treatment directed by tumour molecular status. SECONDARY OBJECTIVES: I. Estimate the rate of isolated vaginal recurrence, para-aortic recurrence and dis...more > Protocol #24-1417 Location: University of Colorado Hospital |
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NRG-CC008: A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers [SOROC]
PRIMARY OBJECTIVE: I. To compare the non-inferiority of bilateral salpingectomy (BLS) with delayed oophorectomy to bilateral salpingo-oophorectomy (BSO) to reduce the risk of ovarian cancer among individuals with deleterious BRCA1 germline mutations. SECONDARY OBJECTIVES: I. To pr...more > Protocol #20-2079 Location: Highlands Ranch Hospital, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital |
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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
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...more > Protocol #23-2420 Location: Lone Tree Medical Center, University of Colorado Hospital |
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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
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...more > Protocol #19-0376 Location: 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 |
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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.
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...more > Protocol #23-2048 Location: CTRC Inpatient, University of Colorado Hospital |
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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
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...more > Protocol #21-3855 Location: 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 |
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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
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...more > Protocol #21-3608 Location: Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital |
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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"
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...more > Protocol #24-0700 Location: Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital |
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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)
To screen and assign patients to ComboMATCH treatment trials....more > Protocol #24-0233 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Outpatient CTRC, Poudre Valley Hospital, University of Colorado Hospital |
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A phase I/II study of VLS-1488 (an oral KIF18A inhibitor) in subjects with advanced cancer
This a first-in-human phase I/II study designed to assess the safety, tolerability and preliminary efficacy of VLS-1488 monotherapy and consists of two parts: Dose Escalation and Dose Expansion. Dose Escalation will examine the safety and tolerability of VLS-1488 in different solid tumo...more > Protocol #23-1991 Location: CTRC Inpatient, University of Colorado Hospital |
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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"
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-...more > Protocol #23-1258 Location: 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 |
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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
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....more > Protocol #23-1448 Location: Lone Tree Medical Center, University of Colorado Hospital |
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Cannabis for Palliative Care in Cancer: A Placebo-controlled Randomized Trial of Full Spectrum Hemp-derived CBD/THC
This study involves a total of 4 visits over the course of 8 weeks. Most of the appointments will be conducted solely out of the Anschutz Health Sciences Building (AHSB) except for appointment 3; this appointment will start at your home in our mobile and will finish at AHSB. At each appoin...more > Protocol #23-0982 Location: Outpatient CTRC, University of Colorado, Boulder |
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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
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...more > Protocol #21-4129 Location: Highlands Ranch Hospital, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital |
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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)
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...more > Protocol #21-4846 Location: CTRC Inpatient, University of Colorado Hospital |
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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
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...more > Protocol #21-3607 Location: Cherry Creek Medical Center, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital |
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Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)
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...more > Protocol #21-3724 Location: CTRC Inpatient, University of Colorado Hospital |
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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
This is a first -in-human study. This study mainly aims to test the safety and side effects of the study drugs and to find the best does of AGEN1181 alone and in combination with balstilimab for future studies....more > Protocol #20-2042 Location: Outpatient CTRC, University of Colorado Hospital |
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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"
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: ...more > Protocol #20-0359 Location: 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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NRG-GY028, "A Phase IB and Randomized Phase II Trial of Megestrol Acetate with or without Ipatasertib in Recurrent or Metastatic Endometrioid Endometrial Cancer"
PRIMARY OBJECTIVES: I. Determine the toxicity of ipatasertib in combination with megestrol acetate in women with metastatic grade 1-2 endometrioid endometrial cancer and establish the recommended phase II dose. (Phase I) II. Compare the progression free survival of the combination of ip...more > Protocol #23-0365 Location: University of Colorado Hospital |
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Early Rebiopsy to Identify Mechanisms and Biomarkers of Tumor Cell Survival Following Systemic Therapy for Lung Cancer
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...more > Protocol #15-2316 Location: Lone Tree Medical Center, University of Colorado Hospital |
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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
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...more > Protocol #23-1523 Location: Cherry Creek Medical Center, Highlands Ranch Hospital, 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)
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...more > Protocol #24-0171 Location: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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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)
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...more > Protocol #23-2225 Location: CTRC Inpatient, University of Colorado Hospital |
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Improving patient-centered Ob-Gyn care for Black women: Co-designing solutions to mitigate systemic racism, discrimination and bias
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...more > Protocol #23-2269 Location: Department Specific Free Standing Clinic, University of Colorado Hospital |
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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"
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...more > Protocol #23-1917 Location: University of Colorado Hospital |
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The SURVENT Trial: A Multicenter Randomized Controlled Trial of Surveillance vs. Endoscopic Therapy for Barrett's Esophagus with Low-grade Dysplasia
A Multicenter Randomized Controlled Trial of Surveillance vs. Endoscopic Therapy for Barrett's Esophagus with Low-grade Dysplasia...more > Protocol #21-4972 Locations: Baylor Scott & White Health, Case Western Reserve University, Cleveland Clinic, Main, Columbia University, Dartmouth University, Florida Digestive, Geisinger Medical Center, Johns Hopkins/The Sidney Kimmel Cancer Center, Kaiser Permanente of Colorado, Mayo Clinic, Jacksonville, Mayo Clinic, Rochester, Medical University of South Carolina, Northwestern University, Thomas Jefferson University Hospital Cancer Center, UCLA - University of California, University of Colorado Hospital, University of Michigan, University of North Carolina, University of Pennsylvania, Washington University, Siteman Cancer Center |
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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
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...more > Protocol #22-1394 Location: CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital |
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EA2182: A Randomized Phase II Study of De-Intensified Chemo Radiation for Early Stage Anal Squamous Cell Carcinoma(DECREASE)
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...more > Protocol #21-4429 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital |
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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)
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...more > Protocol #24-0927 Location: Cherry Creek Medical Center, Highlands Ranch Hospital, 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
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...more > Protocol #23-0518 Location: University of Colorado Hospital |
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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
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...more > Protocol #23-0488 Location: CTRC Inpatient, Lone Tree Medical Center, Outpatient CTRC, University of Colorado Hospital |
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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
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) ...more > Protocol #22-0927 Location: 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 |