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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: mFOLFOX6
Atezolizumab (MPDL3280A)
BEVACIZUMAB
Principal Investigator: Howard Hochster M.D
Scope: National
Therapies Involved: Chemotherapy multiple agents systemic
Chemotherapy single agent systemic
Participating Institutions:
  • Rutgers Cancer Institute of New Jersey

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