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A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread (CheckMate142)

Primary Purpose

Microsatellite Unstable Colorectal Cancer, Microsatellite Stable Colorectal Cancer, Mismatch Repair Proficient Colorectal Cancer

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ipilimumab
Nivolumab
Cobimetinib
Daratumumab
BMS-986016
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Microsatellite Unstable Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Local Institution - 0028
  • Local Institution - 0004
  • Local Institution - 0001
  • Local Institution - 0008
  • Local Institution - 0002
  • Local Institution - 0036
  • Allina Health Cancer Institute
  • Local Institution - 0034
  • Local Institution - 0024
  • Local Institution - 0029
  • Local Institution - 0005
  • Local Institution - 0041
  • Local Institution - 0013
  • Local Institution - 0006
  • Local Institution - 0003
  • Local Institution - 0040
  • Local Institution - 0039
  • Local Institution - 0037
  • Local Institution - 0019
  • Local Institution - 0018
  • Local Institution - 0020
  • Local Institution - 0027
  • Local Institution - 0016
  • Local Institution - 0025
  • Local Institution - 0022
  • Local Institution - 0023
  • Local Institution - 0033
  • Local Institution - 0030
  • Local Institution - 0035
  • Local Institution - 0032
  • Local Institution - 0012
  • Local Institution - 0010
  • Local Institution - 0011

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Nivolumab Monotherapy

Nivolumab + Ipilimumab

Nivolumab + Ipilimumab Cohort C3

Nivolumab + Ipilimumab + Cobimetinib Cohort C4

Nivolumab + BMS-986016 Cohort C5

Nivolumab + Daratumumab Cohort C6

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

ORR by RECIST v1.1 by Independent Radiology Review Committee (IRRC)

Full Information

First Posted
December 18, 2013
Last Updated
September 11, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02060188
Brief Title
A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread
Acronym
CheckMate142
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 12, 2014 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microsatellite Unstable Colorectal Cancer, Microsatellite Stable Colorectal Cancer, Mismatch Repair Proficient Colorectal Cancer, Mismatch Repair Deficient Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
385 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nivolumab Monotherapy
Arm Type
Experimental
Arm Title
Nivolumab + Ipilimumab
Arm Type
Experimental
Arm Title
Nivolumab + Ipilimumab Cohort C3
Arm Type
Experimental
Arm Title
Nivolumab + Ipilimumab + Cobimetinib Cohort C4
Arm Type
Experimental
Arm Title
Nivolumab + BMS-986016 Cohort C5
Arm Type
Experimental
Arm Title
Nivolumab + Daratumumab Cohort C6
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
Yervoy
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
BMS-936558, Opdivo
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Cobimetinib
Other Intervention Name(s)
Cotellic
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Daratumumab
Other Intervention Name(s)
Darzalex
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
BMS-986016
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0028
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
Local Institution - 0004
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Local Institution - 0001
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Local Institution - 0008
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Local Institution - 0002
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Local Institution - 0036
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Allina Health Cancer Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Local Institution - 0034
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Local Institution - 0024
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Local Institution - 0029
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Local Institution - 0005
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Local Institution - 0041
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Local Institution - 0013
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Local Institution - 0006
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Local Institution - 0003
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Local Institution - 0040
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Local Institution - 0039
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Local Institution - 0037
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Local Institution - 0019
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Local Institution - 0018
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Local Institution - 0020
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Local Institution - 0027
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Local Institution - 0016
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Local Institution - 0025
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Local Institution - 0022
City
Dublin 4
ZIP/Postal Code
0
Country
Ireland
Facility Name
Local Institution - 0023
City
Dublin 9
ZIP/Postal Code
0
Country
Ireland
Facility Name
Local Institution - 0033
City
Galway
ZIP/Postal Code
0
Country
Ireland
Facility Name
Local Institution - 0030
City
Candiolo, Torino
ZIP/Postal Code
10060
Country
Italy
Facility Name
Local Institution - 0035
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Local Institution - 0032
City
Padova
ZIP/Postal Code
Padova
Country
Italy
Facility Name
Local Institution - 0012
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Local Institution - 0010
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Local Institution - 0011
City
Sevilla
ZIP/Postal Code
41013
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
34637336
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.
Results Reference
derived
PubMed Identifier
29355075
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.
Results Reference
derived
PubMed Identifier
28734759
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. Erratum In: Lancet Oncol. 2017 Sep;18(9):e510.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form

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A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread

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