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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) - CA209-8HW

Updated: 2 November, 2020   |   ClinicalTrials.gov

Print Friendly Summary

Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 3


  • Gender(s)

  • 18+

    Age Range

  • 86


  • Recruiting

Treatment Options

Study Arms
Experimental: Arm A: Nivolumab Monotherapy
Biological: Nivolumab
Experimental: Arm B: Nivolumab + Ipilimumab Combination
Biological: Ipilimumab Biological: Nivolumab
Active Comparator: Arm C: Investigator's Choice Chemotherapy
Drug: Oxaliplatin Drug: Fluorouracil Drug: Irinotecan Drug: Bevacizumab Drug: Cetuximab Drug: Leucovorin

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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 MSI-H or dMMR status per local standard of practice - Eastern cooperative oncology group (ECOG) performance status lower than or equal to 1 Exclusion Criteria: - Participants with 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

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

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