Colorectal Cancer Metastatic dMMR/MSI-H Immuno-Therapy (COMMIT) Study: A Randomized Phase III Study of mFOLFOX6/Bevacizumab/Atezolizumab Combination Versus Single Agent Atezolizumab in the First-Line Treatment of Patients With Deficient DNA Mismatch Repair (dMMR)/Microsatellite Instability-High (MSI-H) Metastatic Colorectal Cancer
We are studying how well combination chemotherapy, bevacizumab, and/or atezolizumab work in treating people with deficient deoxyribonucleic acid (DNA) mismatch repair colorectal cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Chemotherapy drugs, such as fluorouracil, oxaliplatin, and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab may stop or slow colorectal cancer by blocking the growth of new blood vessels necessary for tumor growth. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy, bevacizumab, and atezolizumab may work better in treating patients with colorectal cancer.
• diagnosis of metastatic adenocarcinoma of colon or rectum without previous chemotherapy or any other systemic therapy for metastatic colorectal cancer except for one cycle of FOLFOX or capecitabine and oxaliplatin (CAPOX), with or without bevacizumab
• tumor determined to be mismatch-repair deficient (dMMR)
• able to walk & do selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• additional criteria apply (study staff will review)
• women who are pregnant or breast feeding
• treatment with oxaliplatin chemotherapy within 6 months prior to randomization
• history of significant liver, heart, lung, or autoimmune disease etc. (study staff will review)
Drug: Atezolizumab, Biological: Bevacizumab, Procedure: Biospecimen Collection, Procedure: Computed Tomography, Drug: Fluorouracil, Drug: Leucovorin, Procedure: Magnetic Resonance Imaging, Drug: Oxaliplatin, Procedure: Positron Emission Tomography, Other: Quality-of-Life Assessment, Other: Questionnaire Administration
Cancer
Colon Cancer, Metastatic Colorectal Adenocarcinoma, Rectal Cancer, Stage IV Colorectal Cancer