A Phase 3 Randomized Clinical Trial of Nivolumab Alone, Nivolumab in Combination With Ipilimumab, or Investigator's Choice Chemotherapy in Participants With Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Metastatic Colorectal Cancer (CheckMate 8HW)

  • STATUS
    Recruiting
  • End date
    Jun 10, 2026
  • participants needed
    831
  • sponsor
    Bristol-Myers Squibb
Updated on 28 October 2022
fluorouracil
oxaliplatin
leucovorin
irinotecan
bevacizumab
cetuximab
nivolumab
microsatellite instability high

Summary

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.

Details
Condition Metastatic Colorectal Cancer
Treatment Cetuximab, fluorouracil, Ipilimumab, bevacizumab, Irinotecan, Oxaliplatin, Leucovorin, Nivolumab
Clinical Study IdentifierNCT04008030
SponsorBristol-Myers Squibb
Last Modified on28 October 2022

Eligibility

Yes No Not Sure

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
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