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NRG-GI004: Colorectal Cancer Metastatic dMMR Immuno-Therapy (COMMIT) Study: A Randomized Phase III Study of mFOLFOX6/Bevacizumab Combination Chemotherapy with or Without Atezolizumab or Atezolizumab Monotherapy in the First-Line Treatment of Patients with Deficient DNA Mismatch Repair (dMMR) Metastatic Colorectal Cancer

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

1.2 Secondary Objectives
1.2.1 To compare the overall survival
1.2.2 To compare the objective response rates (ORR) per RECIST 1.1
1.2.3 To determine the safety profiles of the combination of mFOLFOX6/bevacizumab/atezolizumab and atezolizumab monotherapy in patients with dMMR mCRC
1.2.4 To compare the surgical conversion rate
1.2.5 To compare disease control rate (CR + PR + SD) at 12 months.
1.2.6 To determine the duration of response and stable disease
1.2.7 To determine the progression-free survival (PFS) by retrospective central independent scan review

1.3 Exploratory objectives
1.3.1 To compare the health-related quality of life and patient-reported symptoms

1.4 Translational Objectives
1.4.1 To bank tissue and blood samples for other future correlative studies from patients enrolled on the study

Protocol Number: 071807
Phase: Phase III
Applicable Disease Sites: Colon
Drugs Involved: Atezolizumab (MPDL3280A)
BEVACIZUMAB
mFOLFOX6
Principal Investigator: Howard Hochster M.D
Scope: National
Therapies Involved: Chemotherapy single agent systemic
Chemotherapy multiple agents systemic
Participating Institutions:
  • Rutgers Cancer Institute of New Jersey
  • RWJBarnabas Health
    • Robert Wood Johnson University Hospital, Hamilton
    • Robert Wood Johnson University Hospital, Somerset
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

For further information about clinical trials, please contact us at 732-235-7356.