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)

Official Title

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

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.

Trial Description

Primary Outcome:

• Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) (arm B vs A, all lines, centrally confirmed)
• PFS by BICR (arm B vs C, 1L, centrally confirmed)

• Overall Response Rate (ORR) by BICR (arm B vs A, all lines, centrally confirmed)
• Overall Survival (OS) (arm B vs A, all lines, centrally confirmed)
• PFS by Investigator Assessment (arm B vs A, all lines, centrally confirmed)
• PFS by BICR among all randomized participants (arm B vs A, all lines, per local testing)
• PFS by BICR (arm B vs A, 1L, centrally confirmed)
• ORR by BICR (arm B vs C, 1L, centrally confirmed)
• ORR by BICR (arm B vs A, 1L, centrally confirmed)
• OS (arm B vs A, 1L, centrally confirmed)
• PFS by BICR (arm A vs C, 1L, centrally confirmed)
• OS (arm B vs C, 1L, centrally confirmed)
• ORR by BICR (arm A vs C, 1L, centrally confirmed)
• OS (arm A vs C, 1L, centrally confirmed)
• PFS by Investigator (arm A, B and C, 1L, centrally confirmed)
• PFS by BICR among all randomized participants who have not received prior treatment (arm B vs C, 1L, per local testing)
• PFS by BICR among all randomized participants who have not received prior treatment (arm B vs A, 1L, per local testing)
• PFS by BICR (arm B vs C, 1L, by each central test)
• PFS by BICR (arm B vs A, all lines, by each central test)
• PFS by BICR (crossover cohort, centrally confirmed)
• ORR by BICR (crossover cohort, centrally confirmed)

View this trial on ClinicalTrials.gov