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
Description
Brief 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.
Phase
N/AInclusion and Exclusion 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
- 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
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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