NCT02060188

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
385

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2014

Longer than P75 for phase_2

Geographic Reach
8 countries

32 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 11, 2014

Completed
29 days until next milestone

Study Start

First participant enrolled

March 12, 2014

Completed
10.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2024

Completed
1 year until next milestone

Results Posted

Study results publicly available

November 6, 2025

Completed
Last Updated

November 6, 2025

Status Verified

October 1, 2025

Enrollment Period

10.6 years

First QC Date

December 18, 2013

Results QC Date

October 21, 2025

Last Update Submit

October 21, 2025

Conditions

Microsatellite Unstable Colorectal CancerMicrosatellite Stable Colorectal CancerMismatch Repair Proficient Colorectal CancerMismatch Repair Deficient Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    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)

    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)

Study Arms (6)

Nivolumab Monotherapy

EXPERIMENTAL
Drug: Nivolumab

Nivolumab + Ipilimumab

EXPERIMENTAL
Drug: IpilimumabDrug: Nivolumab

Nivolumab + Ipilimumab Cohort C3

EXPERIMENTAL
Drug: IpilimumabDrug: Nivolumab

Nivolumab + Ipilimumab + Cobimetinib Cohort C4

EXPERIMENTAL
Drug: IpilimumabDrug: NivolumabDrug: Cobimetinib

Nivolumab + BMS-986016 Cohort C5

EXPERIMENTAL
Drug: NivolumabDrug: BMS-986016

Nivolumab + Daratumumab Cohort C6

EXPERIMENTAL
Drug: NivolumabDrug: Daratumumab

Interventions

IpilimumabDRUG

Specified dose on specified days

Also known as: Yervoy
Nivolumab + IpilimumabNivolumab + Ipilimumab + Cobimetinib Cohort C4Nivolumab + Ipilimumab Cohort C3
NivolumabDRUG

Specified dose on specified days

Also known as: BMS-936558, Opdivo
Nivolumab + BMS-986016 Cohort C5Nivolumab + Daratumumab Cohort C6Nivolumab + IpilimumabNivolumab + Ipilimumab + Cobimetinib Cohort C4Nivolumab + Ipilimumab Cohort C3Nivolumab Monotherapy
CobimetinibDRUG

Specified dose on specified days

Also known as: Cotellic
Nivolumab + Ipilimumab + Cobimetinib Cohort C4
DaratumumabDRUG

Specified dose on specified days

Also known as: Darzalex
Nivolumab + Daratumumab Cohort C6
BMS-986016DRUG

Specified dose on specified days

Nivolumab + BMS-986016 Cohort C5

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Local Institution - 0028

Gilbert, Arizona, 85234, United States

Location

Local Institution - 0004

Los Angeles, California, 90033, United States

Location

Local Institution - 0001

San Francisco, California, 94115, United States

Location

Local Institution - 0008

Atlanta, Georgia, 30322, United States

Location

Local Institution - 0002

Boston, Massachusetts, 02114, United States

Location

Local Institution - 0036

Boston, Massachusetts, 02114, United States

Location

Local Institution - 0034

Minneapolis, Minnesota, 55407, United States

Location

Local Institution - 0024

Durham, North Carolina, 27710, United States

Location

Local Institution - 0029

Winston-Salem, North Carolina, 27103, United States

Location

Local Institution - 0005

Portland, Oregon, 97213, United States

Location

Local Institution - 0041

Allentown, Pennsylvania, 18103, United States

Location

Local Institution - 0013

Pittsburgh, Pennsylvania, 15232, United States

Location

Local Institution - 0006

Nashville, Tennessee, 37232, United States

Location

Local Institution - 0003

Houston, Texas, 77030-4009, United States

Location

Local Institution - 0040

Westmead, New South Wales, 2145, Australia

Location

Local Institution - 0039

Southport, Queensland, 4215, Australia

Location

Local Institution - 0037

Melbourne, Victoria, 3000, Australia

Location

Local Institution - 0019

Brussels, 1000, Belgium

Location

Local Institution - 0018

Brussels, 1090, Belgium

Location

Local Institution - 0020

Leuven, 3000, Belgium

Location

Local Institution - 0027

Edmonton, Alberta, T6G 1Z2, Canada

Location

Local Institution - 0016

Toronto, Ontario, M5G 1X5, Canada

Location

Local Institution - 0025

Paris, 75571, France

Location

Local Institution - 0022

Dublin, 0, Ireland

Location

Local Institution - 0023

Dublin, 0, Ireland

Location

Local Institution - 0033

Galway, 0, Ireland

Location

Local Institution - 0030

Candiolo, Torino, 10060, Italy

Location

Local Institution - 0035

Modena, 41124, Italy

Location

Local Institution - 0032

Padua, Padova, Italy

Location

Local Institution - 0012

Madrid, Madrid, 28009, Spain

Location

Local Institution - 0010

Madrid, 28050, Spain

Location

Local Institution - 0011

Seville, 41013, Spain

Location

Related Publications (4)

  • 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.

    PMID: 38821718DERIVED

  • 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.

    PMID: 34637336DERIVED

  • 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.

    PMID: 29355075DERIVED

  • 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.

    PMID: 28734759DERIVED

Related Links

MeSH Terms

Interventions

IpilimumabNivolumabcobimetinibdaratumumabrelatlimab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Bristol-Myers Squibb Study Director
Organization
Bristol-Myers Squibb
Clinical.Trials@bms.com
Please email

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2013

First Posted

February 11, 2014

Study Start

March 12, 2014

Primary Completion

October 22, 2024

Study Completion

October 22, 2024

Last Updated

November 6, 2025

Results First Posted

November 6, 2025

Record last verified: 2025-10

Locations

BE(3)US(14)ES(3)CA(2)AU(3)FR(1)IE(3)IT(3)