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Closed (no longer recruiting)Last updated: 2 February 2024

Checkmate 8HW: This phase 3 trial is comparing the benefit of using targeted therapies, either in combination (Nivolumab plus Ipilimumab) or alone (nivolumab) to treat patients with metastatic colorectal cancer.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

Clinical summary

Summary

Patients eligible to participate in this trial will receive either specified doses of Nivolumab alone, Nivolumab in combination with Ipilimumab or a chemotherapy which will be chosen by the Investigator.

Conditions

This trial is treating patients with metastatic colorectal cancer.

Cancer

Bowel Cancers Lower gastrointestinal tract

Age

People18+

Phase

III

Trial Acronym

Checkmate 8HW

More information

Trial Identifiers

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Trial sponsor

Bristol-Myers Squibb (BMS)

Scientific 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

Eligibility

Inclusion

  • 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

Exclusion

  • 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

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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