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Trial ID CA209-8HW  |   NCT04008030

A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC)

Summary

  • Phase 3
  • Male and Female Gender icon
  • 18+
    Age Range
  • 8
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

The main purpose of this study is to compare the clinical benefit, as measured by Progression-Free Survival (PFS), Objective Response Rate (ORR), and Overall Survival (OS), achieved by nivolumab in combination with ipilimumab or by nivolumab monotherapy in participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) metastatic colorectal cancer (mCRC). This study will also compare nivolumab plus ipilimumab combination vs chemotherapy for treatment of MSI-H/dMMR mCRC participants.

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Key Eligibility Criteria

Inclusion Criteria: - Histologically confirmed recurrent or metastatic colorectal cancer (CRC) irrespective of prior treatment history with chemotherapy and/or targeted agents not amenable to surgery (Applicable only during Part 1 enrollment of the study) - Histologically confirmed recurrent or metastatic CRC with no prior treatment history with chemotherapy and/or targeted agents for metastatic disease and not amenable to surgery (Applicable during Part 2 enrollment of the study) - Known tumor microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status per local standard of practice - Eastern cooperative oncology group (ECOG) performance status lower than or equal to 1 Exclusion Criteria: - An active, known or suspected autoimmune disease - History of interstitial lung disease or pneumonitis - Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) Other protocol-defined inclusion/exclusion criteria apply

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Arm A: Nivolumab Monotherapy

ASSIGNED INTERVENTION
  • Biological: Nivolumab

Study Arms

Experimental: Arm B: Nivolumab + Ipilimumab Combination

ASSIGNED INTERVENTION
  • Biological: Nivolumab, Ipilimumab

Study Arms

Active Comparator: Arm C: Investigator's Choice Chemotherapy

ASSIGNED INTERVENTION
  • Drug: Oxaliplatin, Cetuximab, Bevacizumab, Irinotecan, Fluorouracil, Leucovorin
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