A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread (CheckMate142)

October 21, 2025 updated by: Bristol-Myers Squibb

A Phase 2 Clinical Trial of Nivolumab, or Nivolumab Combinations in Recurrent and Metastatic Microsatellite Instability 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 tumor size reduction, in participants with colon cancer that has come back or has spread, and who have a specific biomarker in their tumors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

385

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Local Institution - 0040
    • Queensland
      • Southport, Queensland, Australia, 4215
        • Local Institution - 0039
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Local Institution - 0037
  • Belgium
      • Brussels, Belgium, 1000
        • Local Institution - 0019
      • Brussels, Belgium, 1090
        • Local Institution - 0018
      • Leuven, Belgium, 3000
        • Local Institution - 0020
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Local Institution - 0027
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X5
        • Local Institution - 0016
  • France
      • Paris, France, 75571
        • Local Institution - 0025
  • Ireland
      • Dublin, Ireland
        • Local Institution - 0022
      • Dublin, Ireland
        • Local Institution - 0023
      • Galway, Ireland
        • Local Institution - 0033
  • Italy
      • Candiolo, Torino, Italy, 10060
        • Local Institution - 0030
      • Modena, Italy, 41124
        • Local Institution - 0035
      • Padua, Italy, Padova
        • Local Institution - 0032
  • Spain
      • Madrid, Spain, 28050
        • Local Institution - 0010
      • Seville, Spain, 41013
        • Local Institution - 0011
    • Madrid
      • Madrid, Madrid, Spain, 28009
        • Local Institution - 0012
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Local Institution - 0028
    • California
      • Los Angeles, California, United States, 90033
        • Local Institution - 0004
      • San Francisco, California, United States, 94115
        • Local Institution - 0001
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Local Institution - 0008
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Local Institution - 0002
      • Boston, Massachusetts, United States, 02114
        • Local Institution - 0036
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Local Institution - 0034
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Local Institution - 0024
      • Winston-Salem, North Carolina, United States, 27103
        • Local Institution - 0029
    • Oregon
      • Portland, Oregon, United States, 97213
        • Local Institution - 0005
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Local Institution - 0041
      • Pittsburgh, Pennsylvania, United States, 15232
        • Local Institution - 0013
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Local Institution - 0006
    • Texas
      • Houston, Texas, United States, 77030-4009
        • Local Institution - 0003

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nivolumab + Ipilimumab
Drug: Ipilimumab
Specified dose on specified days
Other Names:
  • Yervoy
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Experimental: Nivolumab Monotherapy
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Experimental: Nivolumab + Ipilimumab Cohort C3
Drug: Ipilimumab
Specified dose on specified days
Other Names:
  • Yervoy
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Experimental: Nivolumab + Ipilimumab + Cobimetinib Cohort C4
Drug: Ipilimumab
Specified dose on specified days
Other Names:
  • Yervoy
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: Cobimetinib
Specified dose on specified days
Other Names:
  • Cotellic
Experimental: Nivolumab + BMS-986016 Cohort C5
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: BMS-986016
Specified dose on specified days
Experimental: Nivolumab + Daratumumab Cohort C6
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: Daratumumab
Specified dose on specified days
Other Names:
  • Darzalex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Investigator Assessment
Time Frame: From date of randomization to the date of objectively documented progression or the date of subsequent systemic cancer therapy, whichever occurs first (Up to approximately 127 months)

Objective Response Rate (ORR) is defined as the number of randomized participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on investigator assessments \[using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\], divided by the number of all randomized participants.

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From date of randomization to the date of objectively documented progression or the date of subsequent systemic cancer therapy, whichever occurs first (Up to approximately 127 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Independent Review Committee (IRC)
Time Frame: From date of randomization to the date of objectively documented progression or the date of subsequent systemic cancer therapy, whichever occurs first (Up to approximately 127 months)

Objective Response Rate (ORR) is defined as the number of randomized participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on IRC\[using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\], divided by the number of all randomized participants.

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From date of randomization to the date of objectively documented progression or the date of subsequent systemic cancer therapy, whichever occurs first (Up to approximately 127 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2014

Primary Completion (Actual)

October 22, 2024

Study Completion (Actual)

October 22, 2024

Study Registration Dates

First Submitted

December 18, 2013

First Submitted That Met QC Criteria

February 10, 2014

First Posted (Estimated)

February 11, 2014

Study Record Updates

Last Update Posted (Estimated)

November 6, 2025

Last Update Submitted That Met QC Criteria

October 21, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-142
  • 2013-003939-30 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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