An Investigational Immuno-therapy Study of Nivolumab, and Nivolumab in Combination With Other Anti-cancer Drugs, in Colon Cancer That Has Come Back or Has Spread (CheckMate142)
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ClinicalTrials.gov Identifier: NCT02060188 |
Recruitment Status :
Active, not recruiting
First Posted : February 11, 2014
Last Update Posted : November 6, 2019
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Condition or disease | Intervention/treatment | Phase |
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Microsatellite Unstable Colorectal Cancer Microsatellite Stable Colorectal Cancer Mismatch Repair Proficient Colorectal Cancer Mismatch Repair Deficient Colorectal Cancer | Drug: Ipilimumab Drug: Nivolumab Drug: Cobimetinib Drug: Daratumumab Drug: anti-LAG-3 antibody | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 340 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2 Clinical Trial of Nivolumab, or Nivolumab Combinations in Recurrent and Metastatic Microsatellite High (MSI-H) and Non-MSI-H Colon Cancer |
Actual Study Start Date : | March 7, 2014 |
Estimated Primary Completion Date : | July 6, 2022 |
Estimated Study Completion Date : | July 6, 2022 |

Arm | Intervention/treatment |
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Experimental: Nivolumab Monotherapy
Nivolumab administered as IV infusion at a dose of 3mg/kg every 2 weeks until disease progression
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Drug: Nivolumab
Other Names:
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Experimental: Nivolumab (Nivo) + Ipilimumab (Ipi)
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Drug: Ipilimumab
Other Name: Yervoy Drug: Nivolumab Other Names:
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Experimental: Nivolumab (Nivo) + Ipilimumab (Ipi) Cohort C3
Nivo IV dosed every 2wk with Ipi IV dosed every 6wk.
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Drug: Ipilimumab
Other Name: Yervoy Drug: Nivolumab Other Names:
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Experimental: Nivolumab (Nivo) + Ipilimumab (Ipi) + Cobimetinib Cohort C4
Nivo IV dosed every 2wk, with Ipi IV dosed every 6wk, combined with Cobimetinib dosed orally once daily 21 days on/7 days off.
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Drug: Ipilimumab
Other Name: Yervoy Drug: Nivolumab Other Names:
Drug: Cobimetinib Other Name: Cotellic |
Experimental: Nivolumab (Nivo) + BMS-986016 Cohort C5
Nivo IV dosed every 2wk with BMS-986016 dosed every 2 wk
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Drug: Nivolumab
Other Names:
Drug: anti-LAG-3 antibody Other Name: BMS-986016 |
Experimental: Nivolumab (Nivo) + Daratumumab Cohort C6
Daratumumab IV dosed weekly for week 1-8; then every 2 wks from Week 9-24; then every 4 wks on week 25; with Nivo dosed every 2 wks starting at week 3 and every 4 wks starting at week 25
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Drug: Nivolumab
Other Names:
Drug: Daratumumab Other Name: Darzalex |
- Objective response rate (ORR) in all MSI-High and non-MSI-High subjects as determined by Investigators [ Time Frame: The final analysis of the primary endpoint will occur at least 6 months after the last enrolled subject's first dose of study therapy (Approximately up to 34 months) ](Tumor imaging assessments will occur every 6 weeks from the date of first dose (+/-1 wk) for the first 24 weeks, then every 12 wks (+/- 1 wk) thereafter until disease progression or treatment is discontinued (whichever occurs later)) (Tumor imaging assessments will occur every 6 weeks from the date of first dose (+/-1 wk) for the first 24 weeks, then every 12 wks (+/- 1 wk) thereafter until disease progression or treatment is discontinued (whichever occurs later))
- ORR in all MSI-H and non-MSI-H subjects based on IRRC determination [ Time Frame: The final analysis of the secondary endpoint will occur the time of the primary endpoint analysis (Approximately up to 34 months) ]Tumor imaging assessments will occur every 6 weeks from the date of first dose (+/- wk) for the first 24 weeks, then every 12 wks (+/- 1 wk) thereafter until disease progression or treatment is discontinued(whichever occurs later)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- Men and women ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Histologically confirmed recurrent or metastatic colorectal cancer
- Measurable disease by CT or MRI
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Testing for MSI Status (by an accredited lab)
- Subjects with microsatellite instability high (MSI-H) tumors will enroll in the MSI-H Cohort (mStage and cStage groups), the C3 Cohort, and the C5 Cohort.
- Subjects with phenotypes that are non-microsatellite instability high (non-MSI-H) will enroll in the non- MSI-H Safety Cohort and the C6, C4 Cohorts.
- Adequate organ function as defined by study-specific laboratory tests
- Must use acceptable form of birth control throughout the study. After the final dose of study drug, an acceptable form of birth control must be used for 23 weeks for women of childbearing potential (WOCBP) and 31 weeks for men who are sexually active with WOCBP
- Signed informed consent
- Willing and able to comply with study procedures
- Subjects 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
- Subjects with active, known or suspected autoimmune disease
- Subjects 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 could apply

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060188

United States, Arizona | |
Banner MD Anderson Cancer Center | |
Gilbert, Arizona, United States, 85234 | |
United States, California | |
USC Norris Comprehensive Cancer Center | |
Los Angeles, California, United States, 90033 | |
Pacific Hematology Oncology Associates | |
San Francisco, California, United States, 94115 | |
United States, Georgia | |
Emory University | |
Atlanta, Georgia, United States, 30322 | |
United States, Massachusetts | |
Dana Farber Cancer Institute. | |
Boston, Massachusetts, United States, 02114 | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
United States, Minnesota | |
Allina Health System | |
Minneapolis, Minnesota, United States, 55407 | |
United States, North Carolina | |
Duke University Office of Research Administration | |
Durham, North Carolina, United States, 27710 | |
Novant Health Oncology Specialists | |
Winston-Salem, North Carolina, United States, 27103 | |
United States, Oregon | |
Providence Cancer Center Oncology and Hematology Care- Eastside | |
Portland, Oregon, United States, 97213 | |
United States, Pennsylvania | |
Lehigh Valley Hospital | |
Allentown, Pennsylvania, United States, 18103 | |
University Of Pittsburgh Cancer Institute | |
Pittsburgh, Pennsylvania, United States, 15232 | |
United States, Tennessee | |
Vanderbilt University Med Ctr | |
Nashville, Tennessee, United States, 37232-0021 | |
United States, Texas | |
Md Anderson Can Cnt | |
Houston, Texas, United States, 77030-4009 | |
Australia, New South Wales | |
Westmead Hospital | |
Westmead, New South Wales, Australia, 2145 | |
Australia, Queensland | |
Tasman Oncology Research Pty Ltd | |
Southport, Queensland, Australia, 4215 | |
Australia, Victoria | |
Royal Melbourne Hospital | |
Parkville, Victoria, Australia, 3050 | |
Belgium | |
Local Institution | |
Brussels, Belgium, 1000 | |
Local Institution | |
Brussels, Belgium, 1090 | |
Local Institution | |
Leuven, Belgium, 3000 | |
Canada, Alberta | |
Local Institution | |
Edmonton, Alberta, Canada, T6G 1Z2 | |
Canada, Ontario | |
Local Institution | |
Toronto, Ontario, Canada, M5G 1X5 | |
France | |
Local Institution | |
Paris, France, 75012 | |
Ireland | |
Local Institution | |
Dublin 4, Ireland | |
Local Institution | |
Dublin 9, Ireland | |
Local Institution | |
Galway, Ireland | |
Italy | |
Local Institution | |
Candiolo, TO, Italy, 10060 | |
Local Institution | |
Modena, Italy, 41124 | |
Local Institution | |
Padova, Italy, Padova | |
Spain | |
Local Institution | |
Madrid, Spain, 28009 | |
Local Institution | |
Madrid, Spain, 28050 | |
Local Institution | |
Sevilla, Spain, 41013 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT02060188 |
Other Study ID Numbers: |
CA209-142 2013-003939-30 ( EudraCT Number ) |
First Posted: | February 11, 2014 Key Record Dates |
Last Update Posted: | November 6, 2019 |
Last Verified: | November 2019 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
Rectal Diseases Nivolumab Ipilimumab Daratumumab Antibodies Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Immunological Antineoplastic Agents |