An Investigational Immuno-therapy Study of Nivolumab, and Nivolumab in Combination With Other Anti-cancer Drugs, in Colon Cancer That Has Come Back or Has Spread

Official Title

A Phase 2 Clinical Trial of Nivolumab, or Nivolumab Combinations in Recurrent and Metastatic Microsatellite High (MSI-H) and Non-MSI-H Colon Cancer


The purpose of this study is to examine if Nivolumab by itself, or Nivolumab in combination with other anti-cancer drugs, will result in meaningful tumour size reduction, in patients with colon cancer that has come back or has spread, and who have a specific biomarker in their tumours.

Trial Description

Primary Outcome:

  • Objective response rate (ORR) in all MSI-High and non-MSI-High subjects as determined by Investigators
Secondary Outcome:
  • ORR in all MSI-H and non-MSI-H subjects based on IRRC determination
Allocation: The Microsatellite Instability High (MSI-High) and C4 and C6 Cohort Parts of the trial are Non-randomized, The Non-MSI high Dose Escalation Phase part of the trial contained a randomized portion

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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society