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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
  • 3
    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

Inclusion Criteria Icon img
:
  • 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)
    1. 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)
      1. Known tumor microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status per local standard of practice
        1. Eastern cooperative oncology group (ECOG) performance status lower than or equal to 1

          Exclusion Criteria

          Exclusion Criteria Icon
          :
          • An active, known or suspected autoimmune disease
            1. History of interstitial lung disease or pneumonitis
              1. Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) Other protocol-defined inclusion/exclusion criteria apply
                Additional Information *

                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: Ipilimumab, Nivolumab

                Study Arms

                Active Comparator: Arm C: Investigator's Choice Chemotherapy

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