Colon Cancer Clinical Trial

Testing the Addition of Nivolumab to Standard Treatment for Patients With Metastatic or Unresectable Colorectal Cancer That Have a BRAF Mutation

Summary

This phase II trial tests whether adding nivolumab to the usual treatment (encorafenib and cetuximab) works better than the usual treatment alone to shrink tumors in patients with colorectal cancer that has spread to other places in the body (metastatic) or that cannot be removed by surgery (unresectable) and whose tumor has a mutation in a gene called BRAF. Encorafenib is in a class of medications called kinase inhibitors. It is used in patients whose cancer has a certain mutation (change) in the BRAF gene. It works by blocking the action of mutated BRAF that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of cancer cells. This may help keep cancer cells from growing. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab in combination with encorafenib and cetuximab may be more effective than encorafenib and cetuximab alone at stopping tumor growth and spreading in patients with metastatic or unresectable BRAF-mutant colorectal cancer.

View Full Description

Full Description

PRIMARY OBJECTIVE:

I. To compare progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 in patients with microsatellite stable (MSS), BRAF^V600E metastatic and/or unresectable colorectal cancer (CRC) randomized to treatment with nivolumab + encorafenib + cetuximab compared to encorafenib + cetuximab.

SECONDARY OBJECTIVES:

I. To compare overall response rate (ORR), including confirmed and unconfirmed, complete and partial response, according to RECIST 1.1 criteria between the two arms.

II. To compare overall survival (OS) between the two arms. III. To compare duration of response between the two arms. IV. To compare safety and tolerability between the two arms. V. To assess immune-related PFS using modified response criteria adapted for immunotherapy (irRC-PFS) in patients treated with nivolumab + encorafenib + cetuximab.

BANKING OBJECTIVE:

I. To bank tissue and blood specimens for future correlative studies.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive encorafenib orally (PO) once daily (QD) on days 1-28, cetuximab intravenously (IV) on days 1 and 15, and nivolumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive encorafenib PO QD on days 1-28 and cetuximab IV on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed until death or 3 years after registration, whichever occurs first.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participants must have a histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or rectum. The date of diagnosis will be determined according to the pathologic date of diagnosis
Participants must have measurable disease according to RECIST1.1 criteria. Computed tomography (CT) scans or magnetic resonance imaging (MRIs) used to assess measurable disease must have been completed within 28 days prior to registration. CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form
Participants must have documented unresectable and/or metastatic disease on CT or MRI imaging. All disease must be assessed and documented on the Baseline Tumor Assessment Form
Participants must have BRAF^V600E mutated colorectal cancer as tested in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory
Participants must have proficient mismatch repair (pMMR) or microsatellite stable (MSS) status as tested in a CLIA-certified laboratory and documented by the treating clinician. Proficient mismatch repair status can be determined by intact expression by immunohistochemistry of all 4 mismatch repair proteins (MLH1, MSH2, MSH6, and PMS2). Microsatellite instability can be determined by polymerase chain reaction (PCR)
Participants with brain metastases must have completed surgery or radiation therapy >= 28 days prior to registration. These participants must have a CT or MRI of the brain showing no new or enlarging lesions within 42 days prior to registration. These participants must also be neurologically asymptomatic and without corticosteroid treatment for at least 7 days prior to registration. Metastatic brain parenchymal disease must have been treated and participant must be off steroids for 7 days prior to registration. The presence of leptomeningeal disease (LMD) is not considered stable disease, and participants with LMD are not eligible for this study
Participants with known evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within 28 days prior to registration
Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with HCV infection who are currently on treatment must have an undetectable HCV viral load within 28 days prior to registration
Participants must have had one or two prior regimens of systemic chemotherapy for metastatic or locally advanced, unresectable disease. (A maintenance regimen of 5-fluorouracil or capecitabine, with or without bevacizumab, should not be counted as a separate line of treatment. The re-introduction of an initially successful induction regimen will not be counted as one additional line of treatment). Prior treatment for metastatic disease is not required for patients who experienced disease recurrence during or within 6 months of completion of adjuvant chemotherapy
Participants must be of age >= 18 years at the time of informed consent
Participants must have a Zubrod performance status of 0 or 1
Participants must have a complete medical history and physical exam within 28 days prior to registration
Absolute neutrophil count >= 1.0 x 10^3/uL (within 28 days prior to registration)
Hemoglobin >= 9 g/dL (within 28 days prior to registration)
Platelets >= 75 x 10^3/uL (within 28 days prior to registration)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to registration)
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x institutional ULN (within 28 days prior to registration)
If liver metastases are present, then it is acceptable for AST level =< 5.0 x ULN, and/or an ALT level =< 5.0 x ULN (within 28 days prior to registration)
Participants must have serum creatinine =< the IULN OR measured OR calculated creatinine clearance >= 50 mL/min using the Cockroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration
Participants must be able to swallow and retain pills
Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2 or better
Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System

Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.

Note: As a part of the OPEN registration process, the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

Exclusion Criteria:

Participants must not have a known positive serology for human immunodeficiency virus (HIV). Encorafenib is contraindicated with concomitant use of non-nucleoside analog reverse transcriptase inhibitors like efavirenz and etravirine. In addition, it is recommended in the investigator brochure of encorafenib to avoid using encorafenib with protease inhibitors. Therefore, because all participants on this study would receive encorafenib for either randomized arm of treatment, participants with HIV who receive these components of highly active antiretroviral therapy (HAART) would be at high risk for complications of drug-drug interaction
Participants must not have had prior treatment with a BRAF inhibitor (including, but not limited to, encorafenib, dabrafenib, or vemurafenib), MEK inhibitor (including, but not limited to, trametinib, selumetinib, or binimetinib), or ERK inhibitor (of note, regorafenib is not considered a BRAF inhibitor for the context of eligibility criteria)
Participants must not have had prior treatment with anti-EGFR therapies
Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
Participants must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of registration. Inhaled or topical steroids and adrenal replacement doses < 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if < 10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted, as long as there has been a washout period for corticosteroids of >= 7 days prior to registration
Participants must not have received a live vaccine within 30 days prior to study registration. Seasonal flu and COVID vaccines that do not contain a live virus are permitted
Participants must not be receiving any other investigational agents
Participants must not have impaired gastrointestinal function or disease that may significantly alter the absorption of study drug (e.g., ulcerative diseases, uncontrolled vomiting, malabsorption syndrome, small bowel resection with decreased intestinal absorption)

Participants must not have a history of inflammatory bowel disease, (including ulcerative colitis and Crohn's disease), symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome and myasthenia gravis, multiple sclerosis).

Note: Participants with Graves' disease will be allowed
Participants must not have a history of pneumonitis that has required oral or intravenous (IV) steroids within the last 12 months
Participants must not have a history of a grade 3 or 4 allergic reaction attributed to humanized or human monoclonal antibody therapy
Participants must not have a history of a prior allogeneic tissue or solid organ transplant
Participants must not have a history of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) within 6 months prior to study registration

Participants must not have uncontrolled blood pressure and hypertension within 28 days prior to registration.

Uncontrolled blood pressure and hypertension is defined as systolic blood pressure (SBP) > 170 mmHg or diastolic blood pressure (DBP) > 100 mmHg within 28 days prior to registration. Participants are permitted to be receiving multiple anti-hypertensive medications (unless otherwise indicated in the study). All blood pressure measurements within the 28 days prior to registration must be SBP =< 170 and DBP =< 100. An exception can be made by a healthcare provider for a participant with a single blood pressure elevation who upon rechecking has a normal blood pressure
Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen or requires concurrent therapy
Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion and vasectomy with testing showing no sperm in the semen
Participants must not be planning treatment with other systemic anti-cancer agents (e.g., chemotherapy, hormonal therapy, immunotherapy) or other treatments not part of protocol-specified anti-cancer therapy including concurrent investigational agents of any type

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

84

Study ID:

NCT05308446

Recruitment Status:

Recruiting

Sponsor:

National Cancer Institute (NCI)

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There are 131 Locations for this study

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Kaiser Permanente Dublin
Dublin California, 94568, United States More Info
Site Public Contact
Contact
877-642-4691
Tatjana Kolevska
Principal Investigator
Kaiser Permanente-Fremont
Fremont California, 94538, United States More Info
Site Public Contact
Contact
877-642-4691
[email protected]
Tatjana Kolevska
Principal Investigator
Kaiser Permanente-Fresno
Fresno California, 93720, United States More Info
Site Public Contact
Contact
877-642-4691
[email protected]
Tatjana Kolevska
Principal Investigator
Kaiser Permanente-Modesto
Modesto California, 95356, United States More Info
Site Public Contact
Contact
877-642-4691
[email protected]
Tatjana Kolevska
Principal Investigator
Kaiser Permanente-Oakland
Oakland California, 94611, United States More Info
Site Public Contact
Contact
877-642-4691
[email protected]
Tatjana Kolevska
Principal Investigator
Kaiser Permanente-Roseville
Roseville California, 95661, United States More Info
Site Public Contact
Contact
877-642-4691
[email protected]
Tatjana Kolevska
Principal Investigator
Kaiser Permanente Downtown Commons
Sacramento California, 95814, United States More Info
Site Public Contact
Contact
877-642-4691
[email protected]
Tatjana Kolevska
Principal Investigator
Kaiser Permanente-South Sacramento
Sacramento California, 95823, United States More Info
Site Public Contact
Contact
877-642-4691
[email protected]
Tatjana Kolevska
Principal Investigator
Kaiser Permanente-San Francisco
San Francisco California, 94115, United States More Info
Site Public Contact
Contact
877-642-4691
[email protected]
Tatjana Kolevska
Principal Investigator
Kaiser Permanente-Santa Teresa-San Jose
San Jose California, 95119, United States More Info
Site Public Contact
Contact
877-642-4691
[email protected]
Tatjana Kolevska
Principal Investigator
Kaiser Permanente San Leandro
San Leandro California, 94577, United States More Info
Site Public Contact
Contact
877-642-4691
[email protected]
Tatjana Kolevska
Principal Investigator
Kaiser Permanente Medical Center - Santa Clara
Santa Clara California, 95051, United States More Info
Site Public Contact
Contact
877-642-4691
[email protected]
Tatjana Kolevska
Principal Investigator
Kaiser Permanente-Santa Rosa
Santa Rosa California, 95403, United States More Info
Site Public Contact
Contact
877-642-4691
[email protected]
Tatjana Kolevska
Principal Investigator
Kaiser Permanente-South San Francisco
South San Francisco California, 94080, United States More Info
Site Public Contact
Contact
877-642-4691
[email protected]
Tatjana Kolevska
Principal Investigator
Kaiser Permanente-Vallejo
Vallejo California, 94589, United States More Info
Site Public Contact
Contact
877-642-4691
[email protected]
Tatjana Kolevska
Principal Investigator
Kaiser Permanente-Walnut Creek
Walnut Creek California, 94596, United States More Info
Site Public Contact
Contact
877-642-4691
[email protected]
Tatjana Kolevska
Principal Investigator
Kaiser Permanente Moanalua Medical Center
Honolulu Hawaii, 96819, United States More Info
Site Public Contact
Contact
808-432-5195
[email protected]
Tatjana Kolevska
Principal Investigator
Saint Alphonsus Cancer Care Center-Boise
Boise Idaho, 83706, United States More Info
Site Public Contact
Contact
734-712-3671
[email protected]
John M. Schallenkamp
Principal Investigator
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell Idaho, 83605, United States More Info
Site Public Contact
Contact
734-712-3671
[email protected]
John M. Schallenkamp
Principal Investigator
Kootenai Health - Coeur d'Alene
Coeur d'Alene Idaho, 83814, United States More Info
Site Public Contact
Contact
406-969-6060
[email protected]
John M. Schallenkamp
Principal Investigator
Saint Alphonsus Medical Center-Nampa
Nampa Idaho, 83686, United States More Info
Site Public Contact
Contact
406-969-6060
[email protected]
John M. Schallenkamp
Principal Investigator
Kootenai Clinic Cancer Services - Post Falls
Post Falls Idaho, 83854, United States More Info
Site Public Contact
Contact
406-969-6060
[email protected]
John M. Schallenkamp
Principal Investigator
Kootenai Cancer Clinic
Sandpoint Idaho, 83864, United States More Info
Site Public Contact
Contact
406-969-6060
[email protected]
John M. Schallenkamp
Principal Investigator
Illinois CancerCare-Bloomington
Bloomington Illinois, 61704, United States More Info
Site Public Contact
Contact
309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Illinois CancerCare-Canton
Canton Illinois, 61520, United States More Info
Site Public Contact
Contact
309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Illinois CancerCare-Carthage
Carthage Illinois, 62321, United States More Info
Site Public Contact
Contact
309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Carle on Vermilion
Danville Illinois, 61832, United States More Info
Site Public Contact
Contact
800-446-5532
[email protected]
Tanmay Sahai
Principal Investigator
Cancer Care Specialists of Illinois - Decatur
Decatur Illinois, 62526, United States More Info
Site Public Contact
Contact
217-876-4762
[email protected]
Bryan A. Faller
Principal Investigator
Decatur Memorial Hospital
Decatur Illinois, 62526, United States More Info
Site Public Contact
Contact
217-876-4762
[email protected]
Bryan A. Faller
Principal Investigator
Illinois CancerCare-Dixon
Dixon Illinois, 61021, United States More Info
Site Public Contact
Contact
815-285-7800
Bryan A. Faller
Principal Investigator
Carle Physician Group-Effingham
Effingham Illinois, 62401, United States More Info
Site Public Contact
Contact
800-446-5532
[email protected]
Tanmay Sahai
Principal Investigator
Crossroads Cancer Center
Effingham Illinois, 62401, United States More Info
Site Public Contact
Contact
217-876-4762
[email protected]
Bryan A. Faller
Principal Investigator
Illinois CancerCare-Eureka
Eureka Illinois, 61530, United States More Info
Site Public Contact
Contact
309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Illinois CancerCare-Galesburg
Galesburg Illinois, 61401, United States More Info
Site Public Contact
Contact
309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Illinois CancerCare-Kewanee Clinic
Kewanee Illinois, 61443, United States More Info
Site Public Contact
Contact
309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Illinois CancerCare-Macomb
Macomb Illinois, 61455, United States More Info
Site Public Contact
Contact
309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Carle Physician Group-Mattoon/Charleston
Mattoon Illinois, 61938, United States More Info
Site Public Contact
Contact
800-446-5532
[email protected]
Tanmay Sahai
Principal Investigator
Cancer Care Center of O'Fallon
O'Fallon Illinois, 62269, United States More Info
Site Public Contact
Contact
217-876-4762
[email protected]
Bryan A. Faller
Principal Investigator
Illinois CancerCare-Ottawa Clinic
Ottawa Illinois, 61350, United States More Info
Site Public Contact
Contact
309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Illinois CancerCare-Pekin
Pekin Illinois, 61554, United States More Info
Site Public Contact
Contact
309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Illinois CancerCare-Peoria
Peoria Illinois, 61615, United States More Info
Site Public Contact
Contact
309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Illinois CancerCare-Peru
Peru Illinois, 61354, United States More Info
Site Public Contact
Contact
309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Illinois CancerCare-Princeton
Princeton Illinois, 61356, United States More Info
Site Public Contact
Contact
309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Southern Illinois University School of Medicine
Springfield Illinois, 62702, United States More Info
Site Public Contact
Contact
217-545-7929
Bryan A. Faller
Principal Investigator
Springfield Clinic
Springfield Illinois, 62702, United States More Info
Site Public Contact
Contact
800-444-7541
Bryan A. Faller
Principal Investigator
Memorial Medical Center
Springfield Illinois, 62781, United States More Info
Site Public Contact
Contact
217-528-7541
[email protected]
Bryan A. Faller
Principal Investigator
Carle Cancer Center
Urbana Illinois, 61801, United States More Info
Site Public Contact
Contact
800-446-5532
[email protected]
Tanmay Sahai
Principal Investigator
Illinois CancerCare - Washington
Washington Illinois, 61571, United States More Info
Site Public Contact
Contact
309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Franciscan Health Indianapolis
Indianapolis Indiana, 46237, United States More Info
Site Public Contact
Contact
317-528-7060
Meghana Raghavendra
Principal Investigator
Franciscan Saint Elizabeth Health - Lafayette East
Lafayette Indiana, 47905, United States More Info
Site Public Contact
Contact
888-823-5923
[email protected]
Meghana Raghavendra
Principal Investigator
Woodland Cancer Care Center
Michigan City Indiana, 46360, United States More Info
Site Public Contact
Contact
219-861-5800
[email protected]
Meghana Raghavendra
Principal Investigator
Franciscan Health Mooresville
Mooresville Indiana, 46158, United States More Info
Site Public Contact
Contact
317-834-3603
Meghana Raghavendra
Principal Investigator
Mary Greeley Medical Center
Ames Iowa, 50010, United States More Info
Site Public Contact
Contact
515-956-4132
Debra M. Prow
Principal Investigator
McFarland Clinic PC - Ames
Ames Iowa, 50010, United States More Info
Site Public Contact
Contact
515-239-4734
[email protected]
Debra M. Prow
Principal Investigator
McFarland Clinic PC-Boone
Boone Iowa, 50036, United States More Info
Site Public Contact
Contact
515-956-4132
Debra M. Prow
Principal Investigator
Mercy Medical Center - Des Moines
Des Moines Iowa, 50314, United States More Info
Site Public Contact
Contact
515-358-6613
[email protected]
Richard L. Deming
Principal Investigator
McFarland Clinic PC-Trinity Cancer Center
Fort Dodge Iowa, 50501, United States More Info
Site Public Contact
Contact
515-956-4132
Debra M. Prow
Principal Investigator
McFarland Clinic PC-Jefferson
Jefferson Iowa, 50129, United States More Info
Site Public Contact
Contact
515-956-4132
Debra M. Prow
Principal Investigator
McFarland Clinic PC-Marshalltown
Marshalltown Iowa, 50158, United States More Info
Site Public Contact
Contact
515-956-4132
Debra M. Prow
Principal Investigator
Saint Joseph Mercy Hospital
Ann Arbor Michigan, 48106, United States More Info
Site Public Contact
Contact
734-712-7251
[email protected]
Christopher M. Reynolds
Principal Investigator
Bronson Battle Creek
Battle Creek Michigan, 49017, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
Saint Joseph Mercy Brighton
Brighton Michigan, 48114, United States More Info
Site Public Contact
Contact
734-712-7251
[email protected]
Christopher M. Reynolds
Principal Investigator
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton Michigan, 48114, United States More Info
Site Public Contact
Contact
734-712-7251
[email protected]
Christopher M. Reynolds
Principal Investigator
Saint Joseph Mercy Canton
Canton Michigan, 48188, United States More Info
Site Public Contact
Contact
734-712-7251
[email protected]
Christopher M. Reynolds
Principal Investigator
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton Michigan, 48188, United States More Info
Site Public Contact
Contact
734-712-7251
[email protected]
Christopher M. Reynolds
Principal Investigator
Saint Joseph Mercy Chelsea
Chelsea Michigan, 48118, United States More Info
Site Public Contact
Contact
734-712-7251
[email protected]
Christopher M. Reynolds
Principal Investigator
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea Michigan, 48118, United States More Info
Site Public Contact
Contact
734-712-7251
[email protected]
Christopher M. Reynolds
Principal Investigator
Ascension Saint John Hospital
Detroit Michigan, 48236, United States More Info
Site Public Contact
Contact
313-343-3166
[email protected]
Christopher M. Reynolds
Principal Investigator
Great Lakes Cancer Management Specialists-Doctors Park
East China Township Michigan, 48054, United States More Info
Site Public Contact
Contact
313-343-3166
[email protected]
Christopher M. Reynolds
Principal Investigator
Genesee Cancer and Blood Disease Treatment Center
Flint Michigan, 48503, United States More Info
Site Public Contact
Contact
810-762-8038
[email protected]
Christopher M. Reynolds
Principal Investigator
Genesee Hematology Oncology PC
Flint Michigan, 48503, United States More Info
Site Public Contact
Contact
810-762-8038
[email protected]
Christopher M. Reynolds
Principal Investigator
Genesys Hurley Cancer Institute
Flint Michigan, 48503, United States More Info
Site Public Contact
Contact
810-762-8038
[email protected]
Christopher M. Reynolds
Principal Investigator
Hurley Medical Center
Flint Michigan, 48503, United States More Info
Site Public Contact
Contact
810-762-8038
wst[email protected]
Christopher M. Reynolds
Principal Investigator
Mercy Health Saint Mary's
Grand Rapids Michigan, 49503, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
Spectrum Health at Butterworth Campus
Grand Rapids Michigan, 49503, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
Academic Hematology Oncology Specialists
Grosse Pointe Woods Michigan, 48236, United States More Info
Site Public Contact
Contact
313-343-3166
[email protected]
Christopher M. Reynolds
Principal Investigator
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods Michigan, 48236, United States More Info
Site Public Contact
Contact
313-343-3166
[email protected]
Christopher M. Reynolds
Principal Investigator
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
West Michigan Cancer Center
Kalamazoo Michigan, 49007, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
Ascension Borgess Cancer Center
Kalamazoo Michigan, 49009, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia Michigan, 48154, United States More Info
Site Public Contact
Contact
734-712-7251
[email protected]
Christopher M. Reynolds
Principal Investigator
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb Michigan, 48044, United States More Info
Site Public Contact
Contact
313-343-3166
[email protected]
Christopher M. Reynolds
Principal Investigator
Mercy Health Mercy Campus
Muskegon Michigan, 49444, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores Michigan, 49444, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
Ascension Providence Hospitals - Novi
Novi Michigan, 48374, United States More Info
Site Public Contact
Contact
248-849-5332
[email protected]
Susan E. Lyons
Principal Investigator
Spectrum Health Reed City Hospital
Reed City Michigan, 49677, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
Marie Yeager Cancer Center
Saint Joseph Michigan, 49085, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
Ascension Providence Hospitals - Southfield
Southfield Michigan, 48075, United States More Info
Site Public Contact
Contact
248-849-5332
[email protected]
Susan E. Lyons
Principal Investigator
Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights Michigan, 48312, United States More Info
Site Public Contact
Contact
313-343-3166
[email protected]
Christopher M. Reynolds
Principal Investigator
Munson Medical Center
Traverse City Michigan, 49684, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
Great Lakes Cancer Management Specialists-Macomb Professional Building
Warren Michigan, 48093, United States More Info
Site Public Contact
Contact
313-343-3166
[email protected]
Christopher M. Reynolds
Principal Investigator
Macomb Hematology Oncology PC
Warren Michigan, 48093, United States More Info
Site Public Contact
Contact
313-343-3166
[email protected]
Christopher M. Reynolds
Principal Investigator
Saint John Macomb-Oakland Hospital
Warren Michigan, 48093, United States More Info
Site Public Contact
Contact
313-343-3166
[email protected]
Christopher M. Reynolds
Principal Investigator
Metro Health Hospital
Wyoming Michigan, 49519, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
Huron Gastroenterology PC
Ypsilanti Michigan, 48106, United States More Info
Site Public Contact
Contact
734-712-7251
[email protected]
Christopher M. Reynolds
Principal Investigator
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti Michigan, 48197, United States More Info
Site Public Contact
Contact
734-712-7251
[email protected]
Christopher M. Reynolds
Principal Investigator
Fairview Southdale Hospital
Edina Minnesota, 55435, United States More Info
Site Public Contact
Contact
952-993-1517
[email protected]
David M. King
Principal Investigator
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park Minnesota, 55416, United States More Info
Site Public Contact
Contact
952-993-1517
[email protected]
David M. King
Principal Investigator
Regions Hospital
Saint Paul Minnesota, 55101, United States More Info
Site Public Contact
Contact
952-993-1517
[email protected]
David M. King
Principal Investigator
Saint Francis Medical Center
Cape Girardeau Missouri, 63703, United States More Info
Site Public Contact
Contact
573-334-2230
[email protected]
Bryan A. Faller
Principal Investigator
Community Hospital of Anaconda
Anaconda Montana, 59711, United States More Info
Site Public Contact
Contact
406-969-6060
[email protected]
John M. Schallenkamp
Principal Investigator
Billings Clinic Cancer Center
Billings Montana, 59101, United States More Info
Site Public Contact
Contact
800-996-2663
[email protected]
John M. Schallenkamp
Principal Investigator
Bozeman Deaconess Hospital
Bozeman Montana, 59715, United States More Info
Site Public Contact
Contact
406-969-6060
[email protected]
John M. Schallenkamp
Principal Investigator
Benefis Healthcare- Sletten Cancer Institute
Great Falls Montana, 59405, United States More Info
Site Public Contact
Contact
406-969-6060
[email protected]
John M. Schallenkamp
Principal Investigator
Kalispell Regional Medical Center
Kalispell Montana, 59901, United States More Info
Site Public Contact
Contact
406-969-6060
[email protected]
John M. Schallenkamp
Principal Investigator
Community Medical Hospital
Missoula Montana, 59804, United States More Info
Site Public Contact
Contact
406-969-6060
[email protected]
John M. Schallenkamp
Principal Investigator
Dartmouth Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States More Info
Site Public Contact
Contact
800-639-6918
[email protected]
Gabriel A. Brooks
Principal Investigator
Roswell Park Cancer Institute
Buffalo New York, 14263, United States More Info
Site Public Contact
Contact
800-767-9355
[email protected]
Deepak Vadehra
Principal Investigator
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst North Carolina, 28374, United States More Info
Site Public Contact
Contact
910-715-3500
[email protected]
Charles S. Kuzma
Principal Investigator
Strecker Cancer Center-Belpre
Belpre Ohio, 45714, United States More Info
Site Public Contact
Contact
800-523-3977
[email protected]
Timothy D. Moore
Principal Investigator
Miami Valley Hospital South
Centerville Ohio, 45459, United States More Info
Site Public Contact
Contact
937-528-2900
[email protected]
Tarek M. Sabagh
Principal Investigator
Adena Regional Medical Center
Chillicothe Ohio, 45601, United States More Info
Site Public Contact
Contact
877-779-7585
[email protected]
Timothy D. Moore
Principal Investigator
Mount Carmel East Hospital
Columbus Ohio, 43213, United States More Info
Site Public Contact
Contact
614-488-2118
[email protected]
Timothy D. Moore
Principal Investigator
Columbus Oncology and Hematology Associates Inc
Columbus Ohio, 43214, United States More Info
Site Public Contact
Contact
614-488-2118
[email protected]
Timothy D. Moore
Principal Investigator
Riverside Methodist Hospital
Columbus Ohio, 43214, United States More Info
Site Public Contact
Contact
614-566-4475
[email protected]
Timothy D. Moore
Principal Investigator
Grant Medical Center
Columbus Ohio, 43215, United States More Info
Site Public Contact
Contact
614-566-4475
[email protected]
Timothy D. Moore
Principal Investigator
The Mark H Zangmeister Center
Columbus Ohio, 43219, United States More Info
Site Public Contact
Contact
614-488-2118
[email protected]
Timothy D. Moore
Principal Investigator
Doctors Hospital
Columbus Ohio, 43228, United States More Info
Site Public Contact
Contact
614-566-3275
[email protected]
Timothy D. Moore
Principal Investigator
Miami Valley Hospital North
Dayton Ohio, 45415, United States More Info
Site Public Contact
Contact
937-528-2900
[email protected]
Tarek M. Sabagh
Principal Investigator
Delaware Health Center-Grady Cancer Center
Delaware Ohio, 43015, United States More Info
Site Public Contact
Contact
740-615-0227
[email protected]
Timothy D. Moore
Principal Investigator
Grady Memorial Hospital
Delaware Ohio, 43015, United States More Info
Site Public Contact
Contact
740-615-2403
[email protected]
Timothy D. Moore
Principal Investigator
Columbus Oncology and Hematology Associates
Dublin Ohio, 43016, United States More Info
Site Public Contact
Contact
614-566-3275
[email protected]
Timothy D. Moore
Principal Investigator
Mount Carmel Grove City Hospital
Grove City Ohio, 43123, United States More Info
Site Public Contact
Contact
877-779-7585
[email protected]
Timothy D. Moore
Principal Investigator
Fairfield Medical Center
Lancaster Ohio, 43130, United States More Info
Site Public Contact
Contact
740-687-8863
[email protected]
Timothy D. Moore
Principal Investigator
OhioHealth Mansfield Hospital
Mansfield Ohio, 44903, United States More Info
Site Public Contact
Contact
419-526-8018
[email protected]
Timothy D. Moore
Principal Investigator
OhioHealth Marion General Hospital
Marion Ohio, 43302, United States More Info
Site Public Contact
Contact
614-488-2118
[email protected]
Timothy D. Moore
Principal Investigator
Knox Community Hospital
Mount Vernon Ohio, 43050, United States More Info
Site Public Contact
Contact
740-393-9000
[email protected]
Timothy D. Moore
Principal Investigator
Licking Memorial Hospital
Newark Ohio, 43055, United States More Info
Site Public Contact
Contact
740-348-4000
[email protected]
Timothy D. Moore
Principal Investigator
Southern Ohio Medical Center
Portsmouth Ohio, 45662, United States More Info
Site Public Contact
Contact
614-488-2118
[email protected]
Timothy D. Moore
Principal Investigator
Springfield Regional Cancer Center
Springfield Ohio, 45504, United States More Info
Site Public Contact
Contact
937-528-2900
[email protected]
Timothy D. Moore
Principal Investigator
Springfield Regional Medical Center
Springfield Ohio, 45505, United States More Info
Site Public Contact
Contact
937-528-2900
[email protected]
Timothy D. Moore
Principal Investigator
Toledo Clinic Cancer Centers-Toledo
Toledo Ohio, 43623, United States More Info
Site Public Contact
Contact
800-444-3561
Rex B. Mowat
Principal Investigator
Saint Ann's Hospital
Westerville Ohio, 43081, United States More Info
Site Public Contact
Contact
614-234-5433
[email protected]
Timothy D. Moore
Principal Investigator
Genesis Healthcare System Cancer Care Center
Zanesville Ohio, 43701, United States More Info
Site Public Contact
Contact
740-454-5232
[email protected]
Timothy D. Moore
Principal Investigator
Cancer Centers of Southwest Oklahoma Research
Lawton Oklahoma, 73505, United States More Info
Site Public Contact
Contact
877-231-4440
Hassan Hatoum
Principal Investigator
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States More Info
Site Public Contact
Contact
405-271-8777
[email protected]
Hassan Hatoum
Principal Investigator
Providence Cancer Institute Clackamas Clinic
Clackamas Oregon, 97015, United States More Info
Site Public Contact
Contact
503-215-2614
[email protected]
Charles W. Drescher
Principal Investigator
Providence Newberg Medical Center
Newberg Oregon, 97132, United States More Info
Site Public Contact
Contact
503-215-2614
[email protected]
Charles W. Drescher
Principal Investigator
Saint Alphonsus Medical Center-Ontario
Ontario Oregon, 97914, United States More Info
Site Public Contact
Contact
406-969-6060
[email protected]
John M. Schallenkamp
Principal Investigator
Providence Portland Medical Center
Portland Oregon, 97213, United States More Info
Site Public Contact
Contact
503-215-2614
[email protected]
Charles W. Drescher
Principal Investigator
Providence Saint Vincent Medical Center
Portland Oregon, 97225, United States More Info
Site Public Contact
Contact
503-215-2614
[email protected]
Charles W. Drescher
Principal Investigator
Lehigh Valley Hospital-Cedar Crest
Allentown Pennsylvania, 18103, United States More Info
Site Public Contact
Contact
610-402-9543
[email protected]
Christopher M. Reynolds
Principal Investigator
Lehigh Valley Hospital - Muhlenberg
Bethlehem Pennsylvania, 18017, United States More Info
Site Public Contact
Contact
610-402-9543
[email protected]
Christopher M. Reynolds
Principal Investigator
Prisma Health Cancer Institute - Spartanburg
Boiling Springs South Carolina, 29316, United States More Info
Site Public Contact
Contact
864-241-6251
Ki Y. Chung
Principal Investigator
Prisma Health Cancer Institute - Easley
Easley South Carolina, 29640, United States More Info
Site Public Contact
Contact
864-522-2066
[email protected]
Ki Y. Chung
Principal Investigator
Prisma Health Cancer Institute - Butternut
Greenville South Carolina, 29605, United States More Info
Site Public Contact
Contact
864-241-6251
Ki Y. Chung
Principal Investigator
Prisma Health Cancer Institute - Faris
Greenville South Carolina, 29605, United States More Info
Site Public Contact
Contact
864-241-6251
Ki Y. Chung
Principal Investigator
Prisma Health Greenville Memorial Hospital
Greenville South Carolina, 29605, United States More Info
Site Public Contact
Contact
864-241-6251
Ki Y. Chung
Principal Investigator
Prisma Health Cancer Institute - Eastside
Greenville South Carolina, 29615, United States More Info
Site Public Contact
Contact
864-241-6251
Ki Y. Chung
Principal Investigator
Prisma Health Cancer Institute - Greer
Greer South Carolina, 29650, United States More Info
Site Public Contact
Contact
864-241-6251
Ki Y. Chung
Principal Investigator
Prisma Health Cancer Institute - Seneca
Seneca South Carolina, 29672, United States More Info
Site Public Contact
Contact
864-241-6251
Ki Y. Chung
Principal Investigator
Norris Cotton Cancer Center-North
Saint Johnsbury Vermont, 05819, United States More Info
Site Public Contact
Contact
802-473-4100
Gabriel A. Brooks
Principal Investigator
ThedaCare Regional Cancer Center
Appleton Wisconsin, 54911, United States More Info
Site Public Contact
Contact
920-364-3605
[email protected]
Matthias Weiss
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

84

Study ID:

NCT05308446

Recruitment Status:

Recruiting

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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