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

NCT ID: NCT02060188

Last Updated: 2025-11-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

385 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-12

Study Completion Date

2024-10-22

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nivolumab Monotherapy

Group Type EXPERIMENTAL

Nivolumab

Intervention Type DRUG

Specified dose on specified days

Nivolumab + Ipilimumab

Group Type EXPERIMENTAL

Ipilimumab

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type DRUG

Specified dose on specified days

Nivolumab + Ipilimumab Cohort C3

Group Type EXPERIMENTAL

Ipilimumab

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type DRUG

Specified dose on specified days

Nivolumab + Ipilimumab + Cobimetinib Cohort C4

Group Type EXPERIMENTAL

Ipilimumab

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type DRUG

Specified dose on specified days

Cobimetinib

Intervention Type DRUG

Specified dose on specified days

Nivolumab + BMS-986016 Cohort C5

Group Type EXPERIMENTAL

BMS-986016

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type DRUG

Specified dose on specified days

Nivolumab + Daratumumab Cohort C6

Group Type EXPERIMENTAL

Daratumumab

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type DRUG

Specified dose on specified days

Interventions

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Daratumumab

Specified dose on specified days

Intervention Type DRUG

BMS-986016

Specified dose on specified days

Intervention Type DRUG

Ipilimumab

Specified dose on specified days

Intervention Type DRUG

Nivolumab

Specified dose on specified days

Intervention Type DRUG

Cobimetinib

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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Yervoy BMS-936558 Opdivo Cotellic Darzalex

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0028

Gilbert, Arizona, United States

Site Status

Local Institution - 0004

Los Angeles, California, United States

Site Status

Local Institution - 0001

San Francisco, California, United States

Site Status

Local Institution - 0008

Atlanta, Georgia, United States

Site Status

Local Institution - 0002

Boston, Massachusetts, United States

Site Status

Local Institution - 0036

Boston, Massachusetts, United States

Site Status

Local Institution - 0034

Minneapolis, Minnesota, United States

Site Status

Local Institution - 0024

Durham, North Carolina, United States

Site Status

Local Institution - 0029

Winston-Salem, North Carolina, United States

Site Status

Local Institution - 0005

Portland, Oregon, United States

Site Status

Local Institution - 0041

Allentown, Pennsylvania, United States

Site Status

Local Institution - 0013

Pittsburgh, Pennsylvania, United States

Site Status

Local Institution - 0006

Nashville, Tennessee, United States

Site Status

Local Institution - 0003

Houston, Texas, United States

Site Status

Local Institution - 0040

Westmead, New South Wales, Australia

Site Status

Local Institution - 0039

Southport, Queensland, Australia

Site Status

Local Institution - 0037

Melbourne, Victoria, Australia

Site Status

Local Institution - 0019

Brussels, , Belgium

Site Status

Local Institution - 0018

Brussels, , Belgium

Site Status

Local Institution - 0020

Leuven, , Belgium

Site Status

Local Institution - 0027

Edmonton, Alberta, Canada

Site Status

Local Institution - 0016

Toronto, Ontario, Canada

Site Status

Local Institution - 0025

Paris, , France

Site Status

Local Institution - 0022

Dublin, , Ireland

Site Status

Local Institution - 0023

Dublin, , Ireland

Site Status

Local Institution - 0033

Galway, , Ireland

Site Status

Local Institution - 0030

Candiolo, Torino, , Italy

Site Status

Local Institution - 0035

Modena, , Italy

Site Status

Local Institution - 0032

Padua, , Italy

Site Status

Local Institution - 0012

Madrid, Madrid, Spain

Site Status

Local Institution - 0010

Madrid, , Spain

Site Status

Local Institution - 0011

Seville, , Spain

Site Status

Countries

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United States Australia Belgium Canada France Ireland Italy Spain

References

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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.

Reference Type DERIVED
PMID: 38821718 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34637336 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29355075 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28734759 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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2013-003939-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA209-142

Identifier Type: -

Identifier Source: org_study_id

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