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 : January 11, 2022

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

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 :	March 14, 2023
Estimated Study Completion Date :	March 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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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

Hide 32 study locations

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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, 97225
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
United States, Texas
The University Of Texas MD Anderson Cancer Center
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
The 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

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

Investigator Inquiry Form This link exits the ClinicalTrials.gov site

FDA Safety Alerts and Recalls 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, García-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, André 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, André 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:	January 11, 2022
Last Verified:	December 2021

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

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