A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread
NCT ID: NCT02060188
Last Updated: 2025-11-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
385 participants
INTERVENTIONAL
2014-03-12
2024-10-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nivolumab Monotherapy
Nivolumab
Specified dose on specified days
Nivolumab + Ipilimumab
Ipilimumab
Specified dose on specified days
Nivolumab
Specified dose on specified days
Nivolumab + Ipilimumab Cohort C3
Ipilimumab
Specified dose on specified days
Nivolumab
Specified dose on specified days
Nivolumab + Ipilimumab + Cobimetinib Cohort C4
Ipilimumab
Specified dose on specified days
Nivolumab
Specified dose on specified days
Cobimetinib
Specified dose on specified days
Nivolumab + BMS-986016 Cohort C5
BMS-986016
Specified dose on specified days
Nivolumab
Specified dose on specified days
Nivolumab + Daratumumab Cohort C6
Daratumumab
Specified dose on specified days
Nivolumab
Specified dose on specified days
Interventions
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Daratumumab
Specified dose on specified days
BMS-986016
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Nivolumab
Specified dose on specified days
Cobimetinib
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0028
Gilbert, Arizona, United States
Local Institution - 0004
Los Angeles, California, United States
Local Institution - 0001
San Francisco, California, United States
Local Institution - 0008
Atlanta, Georgia, United States
Local Institution - 0002
Boston, Massachusetts, United States
Local Institution - 0036
Boston, Massachusetts, United States
Local Institution - 0034
Minneapolis, Minnesota, United States
Local Institution - 0024
Durham, North Carolina, United States
Local Institution - 0029
Winston-Salem, North Carolina, United States
Local Institution - 0005
Portland, Oregon, United States
Local Institution - 0041
Allentown, Pennsylvania, United States
Local Institution - 0013
Pittsburgh, Pennsylvania, United States
Local Institution - 0006
Nashville, Tennessee, United States
Local Institution - 0003
Houston, Texas, United States
Local Institution - 0040
Westmead, New South Wales, Australia
Local Institution - 0039
Southport, Queensland, Australia
Local Institution - 0037
Melbourne, Victoria, Australia
Local Institution - 0019
Brussels, , Belgium
Local Institution - 0018
Brussels, , Belgium
Local Institution - 0020
Leuven, , Belgium
Local Institution - 0027
Edmonton, Alberta, Canada
Local Institution - 0016
Toronto, Ontario, Canada
Local Institution - 0025
Paris, , France
Local Institution - 0022
Dublin, , Ireland
Local Institution - 0023
Dublin, , Ireland
Local Institution - 0033
Galway, , Ireland
Local Institution - 0030
Candiolo, Torino, , Italy
Local Institution - 0035
Modena, , Italy
Local Institution - 0032
Padua, , Italy
Local Institution - 0012
Madrid, Madrid, Spain
Local Institution - 0010
Madrid, , Spain
Local Institution - 0011
Seville, , Spain
Countries
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References
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Overman MJ, Gelsomino F, Aglietta M, Wong M, Limon Miron ML, Leonard G, Garcia-Alfonso P, Hill AG, Cubillo Gracian A, Van Cutsem E, El-Rayes B, McCraith SM, He B, Lei M, Lonardi S. Nivolumab plus relatlimab in patients with previously treated microsatellite instability-high/mismatch repair-deficient metastatic colorectal cancer: the phase II CheckMate 142 study. J Immunother Cancer. 2024 May 31;12(5):e008689. doi: 10.1136/jitc-2023-008689.
Lenz HJ, Van Cutsem E, Luisa Limon M, Wong KYM, Hendlisz A, Aglietta M, Garcia-Alfonso P, Neyns B, Luppi G, Cardin DB, Dragovich T, Shah U, Abdullaev S, Gricar J, Ledeine JM, Overman MJ, Lonardi S. First-Line Nivolumab Plus Low-Dose Ipilimumab for Microsatellite Instability-High/Mismatch Repair-Deficient Metastatic Colorectal Cancer: The Phase II CheckMate 142 Study. J Clin Oncol. 2022 Jan 10;40(2):161-170. doi: 10.1200/JCO.21.01015. Epub 2021 Oct 12.
Overman MJ, Lonardi S, Wong KYM, Lenz HJ, Gelsomino F, Aglietta M, Morse MA, Van Cutsem E, McDermott R, Hill A, Sawyer MB, Hendlisz A, Neyns B, Svrcek M, Moss RA, Ledeine JM, Cao ZA, Kamble S, Kopetz S, Andre T. Durable Clinical Benefit With Nivolumab Plus Ipilimumab in DNA Mismatch Repair-Deficient/Microsatellite Instability-High Metastatic Colorectal Cancer. J Clin Oncol. 2018 Mar 10;36(8):773-779. doi: 10.1200/JCO.2017.76.9901. Epub 2018 Jan 20.
Overman MJ, McDermott R, Leach JL, Lonardi S, Lenz HJ, Morse MA, Desai J, Hill A, Axelson M, Moss RA, Goldberg MV, Cao ZA, Ledeine JM, Maglinte GA, Kopetz S, Andre T. Nivolumab in patients with metastatic DNA mismatch repair-deficient or microsatellite instability-high colorectal cancer (CheckMate 142): an open-label, multicentre, phase 2 study. Lancet Oncol. 2017 Sep;18(9):1182-1191. doi: 10.1016/S1470-2045(17)30422-9. Epub 2017 Jul 19.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2013-003939-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-142
Identifier Type: -
Identifier Source: org_study_id
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