NRG-GI004/SWOG-S1610

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

Principal Investigator

Caio Max Saeo Pedro Rocha Lima, MD

Co-Principal Investigator(s)

Michael Overman, MD

Status

Disease Site

Gastrointestinal [GI] Colorectal

Phase

III

Developmental Therapeutics

No

Primary Objective

To determine the efficacy, based on PFS, of mFOLFOX6/bevacizumab plus atezolizumab (combination) and atezolizumab (single agent) as compared to mFOLFOX6/bevacizumab (control).

Protocol and Other Documents

Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website

Site Initiation Visit (SIV) Video is posted to CTSU.

 

NRG-GI004/SWOG-S1610 Request for Supplies from NRG Biobank PGH

Patient Population

Patients with a diagnosis of metastatic adenocarcinoma of colon or rectum without previous chemotherapy or any other systemic therapy for metastatic colorectal cancer.

Tumor determined to be mismatch-repair deficient (dMMR) by CLIA-certified immunohistochemical (IHC) assay with a panel of all four IHC markers, including MLH1, MSH2, PMS2, and MSH6.

An adequate amount of archived tumor tissue (FFPE), either from primary colorectal cancer site or metastatic lesions, for central confirmation of dMMR status.

Target Accrual

120