Status:
Recruiting
Disease Site:
Colorectal
Diagnosis:
- dMMR deficient Metastatic colorectal cancer
Phase:
Official Title:
Colorectal Cancer Metastatic dMMR Immuno-Therapy (COMMIT) Study: A Randomized Phase III Study of mFOLFOX6/Bevacizumab Combination Chemotherapy
NCT ID:
NCT#02997228
Link to Full Details:
Description:
This randomized phase III trial studies how well combination chemotherapy, bevacizumab, and/or atezolizumab work in treating patients with deficient DNA mismatch repair colorectal cancer that has spread to other places in the body. Drugs used in chemotherapy, 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. Monoclonal antibodies, such as bevacizumab and atezolizumab, 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.
Eligibility:
Male and Female – 18 years and older
Inclusion Criteria:
- ECOG 0-2
- No previous chemotherapy or any other systemic therapy for metastatic colorectal cancer
- Measurable disease per RECIST 1.1
- Tumor determined to be mismatch-repair deficient 9dMMR) by CLIA-certified IHC assay with panel of all four IHC markers, including MLH1, MSH2, PMS2, MSH6
Exclusion Criteria:
- Uncontrolled BP
- Known DPD
- Prior treatment with oxaliplatin chemotherapy within 6 months piror to randomization.
- Prior treatment with anti-PD-1 or anti-PD-L1