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Closed (no longer recruiting)Last updated: 21 December 2023

CheckMate 142: This phase II immunotherapy trial is assessing nivolumab alone and in combination with ipilimumab for patients with recurrent and metastatic colon cancerPhase 2 Clinical Trial of Nivolumab and Nivolumab Plus Ipilimumab in Recurrent and Metastatic Microsatellite High (MSI-H) Colon Cancer

Clinical summary

Summary

The purpose of this study is to examine if Nivolumab alone or in combination with Ipilimumab will demonstrate a meaningful objective response rate in patients with recurrent and metastatic colon cancer who also have a specific biomarker in their tumors. The Microsatellite Instability High (MSI-High) Part of the trial is Non-randomized, The Non-MSI high part of the trial contains a randomized portion

Conditions

This trial is treating patients with Colon Cancer.

Cancer

Bowel Cancers Lower gastrointestinal tract

Age

People18+

Phase

II

Trial Acronym

CheckMate 142

More information

Trial Identifiers

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Trial sponsor

Bristol-Myers Squibb (BMS)

Scientific Title

Phase 2 Clinical Trial of Nivolumab and Nivolumab Plus Ipilimumab in Recurrent and Metastatic Microsatellite High (MSI-H) Colon Cancer

Eligibility

Inclusion

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Histologically confirmed recurrent or metastatic colorectal cancer
  • Measurable disease per RECIST v1.1
  • Microsatellite instability expression detected by an accredited laboratory
  • Participants enrolled into the C3 Cohort must have not had treatment for their metastatic disease

Exclusion

  • Active brain metastases or leptomeningeal metastases are not allowed
  • Prior treatment with an anti-Programmed Death Receptor (PD)-1, anti-PD-L1, anti-PD-L2, anti-Cytotoxic T-Cell Lymphoma-4 Antigen (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
  • Prior malignancy active within the previous 3 years except for locally curable cancers
  • Participants with active, known or suspected autoimmune disease
  • Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration

Other protocol-defined inclusion/exclusion criteria apply

Inclusion

  • You have had treatment, but your cancer has come back.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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

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The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

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Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.