Microsatellite Unstable Colorectal CancerPhase 2CheckMate142NCT02060188
A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread
A Phase 2 study testing Ipilimumab, Nivolumab and Cobimetinib in people with Microsatellite Unstable Colorectal Cancer and Microsatellite Stable Colorectal Cancer, run by Bristol-Myers Squibb at 32 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microsatellite Unstable Colorectal Cancer, Microsatellite Stable Colorectal Cancer, Mismatch Repair Proficient Colorectal Cancer
- What is being tested?
- Ipilimumab, Nivolumab and Cobimetinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- 32 sitesin 8 countries
- Study dates
- 12 Mar 2014to 22 Oct 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
32 sites in 8 countries.
32 sites in 8 countries
United States14 sites
Local Institution - 0041
Allentown, Pennsylvania, 18103
Local Institution - 0008
Atlanta, Georgia, 30322
Local Institution - 0002
Boston, Massachusetts, 02114
Local Institution - 0036
Boston, Massachusetts, 02114
Local Institution - 0024
Durham, North Carolina, 27710
Local Institution - 0028
Gilbert, Arizona, 85234
Local Institution - 0003
Houston, Texas, 77030-4009
Local Institution - 0004
Los Angeles, California, 90033
Local Institution - 0034
Minneapolis, Minnesota, 55407
Local Institution - 0006
Nashville, Tennessee, 37232
Local Institution - 0013
Pittsburgh, Pennsylvania, 15232
Local Institution - 0005
Portland, Oregon, 97213
Local Institution - 0001
San Francisco, California, 94115
Local Institution - 0029
Winston-Salem, North Carolina, 27103
Australia3 sites
Local Institution - 0037
Melbourne, Victoria, 3000
Local Institution - 0039
Southport, Queensland, 4215
Local Institution - 0040
Westmead, New South Wales, 2145
Belgium3 sites
Local Institution - 0019
Brussels, 1000
Local Institution - 0018
Brussels, 1090
Local Institution - 0020
Leuven, 3000
Ireland3 sites
Local Institution - 0022
Dublin, 0
Local Institution - 0023
Dublin, 0
Local Institution - 0033
Galway, 0
Italy3 sites
Local Institution - 0030
Candiolo, Torino, 10060
Local Institution - 0035
Modena, 41124
Local Institution - 0032
Padova, Padova
Spain3 sites
Local Institution - 0012
Madrid, Madrid, 28009
Local Institution - 0010
Madrid, 28050
Local Institution - 0011
Seville, 41013
Canada2 sites
Local Institution - 0027
Edmonton, Alberta, T6G 1Z2
Local Institution - 0016
Toronto, Ontario, M5G 1X5
About this study
Official title: 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.
- Conditions
- Microsatellite Unstable Colorectal Cancer, Microsatellite Stable Colorectal Cancer, Mismatch Repair Proficient Colorectal Cancer, Mismatch Repair Deficient Colorectal Cancer
- Being tested
- Ipilimumab, Nivolumab, Cobimetinib, Daratumumab, BMS-986016
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpilimumabDrug
Also called Yervoy
Specified dose on specified days
NivolumabDrug
Also called BMS-936558, Opdivo
Specified dose on specified days
CobimetinibDrug
Also called Cotellic
Specified dose on specified days
DaratumumabDrug
Also called Darzalex
Specified dose on specified days
BMS-986016Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab Monotherapy | Experimental | Not described Receives: Drug: Nivolumab |
| Nivolumab + Ipilimumab | Experimental | Not described Receives: Drug: Ipilimumab; Drug: Nivolumab |
| Nivolumab + Ipilimumab Cohort C3 | Experimental | Not described Receives: Drug: Ipilimumab; Drug: Nivolumab |
| Nivolumab + Ipilimumab + Cobimetinib Cohort C4 | Experimental | Not described Receives: Drug: Ipilimumab; Drug: Nivolumab; Drug: Cobimetinib |
| Nivolumab + BMS-986016 Cohort C5 | Experimental | Not described Receives: Drug: Nivolumab; Drug: BMS-986016 |
| Nivolumab + Daratumumab Cohort C6 | Experimental | Not described Receives: Drug: Nivolumab; Drug: Daratumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Investigator Assessment
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.
Measured: 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 (1)
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Independent Review Committee (IRC)
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study start12 Mar 2014
- Primary completion22 Oct 2024
- Study completion22 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Microsatellite Unstable Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060188
- Sponsor's protocol ID
- CA209-142
- Other IDs
- 2013-003939-30
- Acronym
- CheckMate142
- Status last verified
- Oct 2025
- First submitted
- 18 Dec 2013
- Last updated
- 6 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 38821718Lenz 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.
PubMed 34637336Overman 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.
PubMed 29355075Overman 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.
PubMed 28734759
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02060188
- Acronym / sponsor ID
- CheckMate142 / CA209-142
- Conditions
- Microsatellite Unstable Colorectal Cancer, Microsatellite Stable Colorectal Cancer, Mismatch Repair Proficient Colorectal Cancer, Mismatch Repair Deficient Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2014 (actual)
- Primary completion
- 22 Oct 2024 (actual)
- Study completion
- 22 Oct 2024 (actual)
- First posted
- 11 Feb 2014 (estimated)
- Results
- Posted 6 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Nivolumab Monotherapy | Experimental | Drug: Nivolumab |
| Nivolumab + Ipilimumab | Experimental | Drug: Ipilimumab, Drug: Nivolumab |
| Nivolumab + Ipilimumab Cohort C3 | Experimental | Drug: Ipilimumab, Drug: Nivolumab |
| Nivolumab + Ipilimumab + Cobimetinib Cohort C4 | Experimental | Drug: Ipilimumab, Drug: Nivolumab, Drug: Cobimetinib |
| Nivolumab + BMS-986016 Cohort C5 | Experimental | Drug: Nivolumab, Drug: BMS-986016 |
| Nivolumab + Daratumumab Cohort C6 | Experimental | Drug: Nivolumab, Drug: Daratumumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IpilimumabAlso: YervoySpecified dose on specified days | Drug | Nivolumab + Ipilimumab, Nivolumab + Ipilimumab + Cobimetinib Cohort C4, Nivolumab + Ipilimumab Cohort C3 |
| NivolumabAlso: BMS-936558, OpdivoSpecified dose on specified days | Drug | Nivolumab + BMS-986016 Cohort C5, Nivolumab + Daratumumab Cohort C6, Nivolumab + Ipilimumab, Nivolumab + Ipilimumab + Cobimetinib Cohort C4, Nivolumab + Ipilimumab Cohort C3, Nivolumab Monotherapy |
| CobimetinibAlso: CotellicSpecified dose on specified days | Drug | Nivolumab + Ipilimumab + Cobimetinib Cohort C4 |
| DaratumumabAlso: DarzalexSpecified dose on specified days | Drug | Nivolumab + Daratumumab Cohort C6 |
| BMS-986016Specified dose on specified days | Drug | Nivolumab + BMS-986016 Cohort C5 |
Primary outcome
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.
1 secondary outcome
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38821718Overman 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.
- Derived from this study: PubMed 34637336Lenz 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.
- Derived from this study: PubMed 29355075Overman 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.
- Derived from this study: PubMed 28734759Overman 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.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
32 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ipilimumab, Nivolumab and Cobimetinib in people with Microsatellite Unstable Colorectal Cancer and Microsatellite Stable Colorectal Cancer, run by Bristol-Myers Squibb at 32 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Australia, Belgium, Ireland, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02060188, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025.