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
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
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.
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
Ciudad Autonoma Beunos Aires, Buenos Aires 1431, Argentina
CABA, 1199, Argentina
CABA, 1426, Argentina
Kashiwa-shi, Chiba 2778577, Japan
Suita-shi, Osaka 565-0871, Japan
Kitaadachigun, Saitama 362-0806, Japan
Sunto-gun, Shizuoka 4118777, Japan
Chuo-ku, Tokyo 1040045, Japan
Koto-ku, Tokyo 135-8550, Japan
Minato-ku, Tokyo 1058470, Japan
Lorenskog, 1478, Norway