A Study of Nivolumab Alone or Nivolumab Combination Therapy 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 : October 28, 2022

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Bristol-Myers Squibb

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.

Condition or disease	Intervention/treatment	Phase
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: BMS-986016	Phase 2

Expanded Access : An investigational treatment associated with this study has been approved for sale to the public. More info ...

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	385 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 Instability High (MSI-H) and Non-MSI-H Colon Cancer
Actual Study Start Date :	March 12, 2014
Estimated Primary Completion Date :	December 15, 2023
Estimated Study Completion Date :	December 14, 2024

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Constitutional mismatch repair deficiency syndrome

Drug Information available for: Nivolumab

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Nivolumab Monotherapy	Drug: Nivolumab Specified dose on specified days Other Names: BMS-936558 Opdivo
Experimental: Nivolumab + Ipilimumab	Drug: Ipilimumab Specified dose on specified days Other Name: Yervoy 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 Name: 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 Name: Yervoy Drug: Nivolumab Specified dose on specified days Other Names: BMS-936558 Opdivo Drug: Cobimetinib Specified dose on specified days Other Name: 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 Name: Darzalex

Outcome Measures

Primary Outcome Measures :

Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator [ 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) ]

Secondary Outcome Measures :

ORR by RECIST v1.1 by Independent Radiology Review Committee (IRRC) [ Time Frame: The final analysis of the secondary endpoint will occur the time of the primary endpoint analysis (Approximately up to 34 months) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

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

Locations

Show 33 study locations

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United States, Arizona
Local Institution - 0028
Gilbert, Arizona, United States, 85234
United States, California
Local Institution - 0004
Los Angeles, California, United States, 90033
Local Institution - 0001
San Francisco, California, United States, 94115
United States, Georgia
Local Institution - 0008
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Local Institution - 0002
Boston, Massachusetts, United States, 02114
Local Institution - 0036
Boston, Massachusetts, United States, 02114
United States, Minnesota
Allina Health Cancer Institute
Minneapolis, Minnesota, United States, 55407
Local Institution - 0034
Minneapolis, Minnesota, United States, 55407
United States, North Carolina
Local Institution - 0024
Durham, North Carolina, United States, 27710
Local Institution - 0029
Winston-Salem, North Carolina, United States, 27103
United States, Oregon
Local Institution - 0005
Portland, Oregon, United States, 97225
United States, Pennsylvania
Local Institution - 0041
Allentown, Pennsylvania, United States, 18103
Local Institution - 0013
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Local Institution - 0006
Nashville, Tennessee, United States, 37232
United States, Texas
Local Institution - 0003
Houston, Texas, United States, 77030-4009
Australia, New South Wales
Local Institution - 0040
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Local Institution - 0039
Southport, Queensland, Australia, 4215
Australia, Victoria
Local Institution - 0037
Melbourne, Victoria, Australia, 3000
Belgium
Local Institution - 0019
Brussels, Belgium, 1000
Local Institution - 0018
Brussels, Belgium, 1090
Local Institution - 0020
Leuven, Belgium, 3000
Canada, Alberta
Local Institution - 0027
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Local Institution - 0016
Toronto, Ontario, Canada, M5G 1X5
France
Local Institution - 0025
Paris, France, 75012
Ireland
Local Institution - 0022
Dublin 4, Ireland, 0
Local Institution - 0023
Dublin 9, Ireland, 0
Local Institution - 0033
Galway, Ireland, 0
Italy
Local Institution - 0030
Candiolo, Torino, Italy, 10060
Local Institution - 0035
Modena, Italy, 41124
Local Institution - 0032
Padova, Italy, Padova
Spain
Local Institution - 0012
Madrid, Spain, 28009
Local Institution - 0010
Madrid, Spain, 28050
Local Institution - 0011
Sevilla, Spain, 41013

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

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Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trial Information This link exits the ClinicalTrials.gov site

BMS Clinical Trial Patient Recruiting This link exits the ClinicalTrials.gov site

FDA Safety Alerts and Recalls This link exits the ClinicalTrials.gov site

Investigator Inquiry Form This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Erratum In: Lancet Oncol. 2017 Sep;18(9):e510.

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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:	October 28, 2022
Last Verified:	October 2022

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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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 Relatlimab Daratumumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action

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