TriangleNCT02060188 · CITED IN SOURCE DOCUMENTS
A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2025-11-06
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Investigator Assessment
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Independent Review Committee (IRC)
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- 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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- intervention Names
- Drug: Nivolumab
- label
- Nivolumab Monotherapy
- type
- EXPERIMENTAL
- intervention Names
- Drug: Ipilimumab
- Drug: Nivolumab
- label
- Nivolumab + Ipilimumab
- type
- EXPERIMENTAL
- intervention Names
- Drug: Ipilimumab
- Drug: Nivolumab
- label
- Nivolumab + Ipilimumab Cohort C3
- type
- EXPERIMENTAL
- intervention Names
- Drug: Ipilimumab
- Drug: Nivolumab
- Drug: Cobimetinib
- label
- Nivolumab + Ipilimumab + Cobimetinib Cohort C4
- type
- EXPERIMENTAL
- intervention Names
- Drug: Nivolumab
- Drug: BMS-986016
- label
- Nivolumab + BMS-986016 Cohort C5
- type
- EXPERIMENTAL
- intervention Names
- Drug: Nivolumab
- Drug: Daratumumab
- label
- Nivolumab + Daratumumab Cohort C6
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Nivolumab + Ipilimumab
- Nivolumab + Ipilimumab + Cobimetinib Cohort C4
- Nivolumab + Ipilimumab Cohort C3
- description
- Specified dose on specified days
- name
- Ipilimumab
- other Names
- Yervoy
- type
- DRUG
- arm Group Labels
- Nivolumab + BMS-986016 Cohort C5
- Nivolumab + Daratumumab Cohort C6
- Nivolumab + Ipilimumab
- Nivolumab + Ipilimumab + Cobimetinib Cohort C4
- Nivolumab + Ipilimumab Cohort C3
- Nivolumab Monotherapy
- description
- Specified dose on specified days
- name
- Nivolumab
- other Names
- BMS-936558
- Opdivo
- type
- DRUG
- arm Group Labels
- Nivolumab + Ipilimumab + Cobimetinib Cohort C4
- description
- Specified dose on specified days
- name
- Cobimetinib
- other Names
- Cotellic
- type
- DRUG
- arm Group Labels
- Nivolumab + Daratumumab Cohort C6
- description
- Specified dose on specified days
- name
- Daratumumab
- other Names
- Darzalex
- type
- DRUG
- arm Group Labels
- Nivolumab + BMS-986016 Cohort C5
- description
- Specified dose on specified days
- name
- BMS-986016
- type
- DRUG
Study design
- allocation
- NON_RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 385
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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.
- measure
- 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)
- secondary Outcomes
- description
- 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.
- measure
- 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)
Full study description
- brief Summary
- 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.
Source references
- references
- citation
- 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.
- pmid
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- type
- DERIVED
- citation
- 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.
- pmid
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- type
- DERIVED
- citation
- 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.
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- type
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- citation
- 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.
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- type
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- see Also Links
- label
- BMS Clinical Trial Information
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Preserved source evidence · Independent clinical review pending · Not medical advice