A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Patients With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC)

Official Title

A Phase 3b 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 patients with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) metastatic colorectal cancer.

Trial Description

Primary Outcome:

  • Progression-Free Survival (PFS) as assessed by Blinded Independent Central Review (BICR)
Secondary Outcome:
  • Progression-Free Survival by Investigator Assessment
  • Overall Response Rate (ORR) by Blinded Independent Central Review
  • Overall Survival (OS)
  • Disease Control Rate (DCR) by Blinded Independent Central Review
  • Time to Response (TTR)
  • Duration of Response (DOR)
  • Overall Response Rate (ORR) by investigator assessment
  • Disease Control Rate by Investigator Assessment

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society