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New hope for advanced colon cancer: immune drug shrinks tumors in genetic subtype

NCT ID NCT02060188

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether the immunotherapy drug nivolumab, alone or with other drugs, can shrink tumors in people with colon cancer that has returned or spread. It included 385 participants whose tumors had a specific genetic feature called MSI-H or were non-MSI-H. The goal was to see if the treatment could reduce tumor size meaningfully.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

385 people

The number who actually took part.

Started

Mar 2014

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal carcinoma Lynch syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Microsatellite unstable colorectal cancer Microsatellite-stable colorectal cancer Mismatch repair deficient colorectal cancer Mismatch repair proficient colorectal cancer

Contacts and locations

Locations

  • Local Institution - 0001

    San Francisco, California, 94115, United States

  • Local Institution - 0002

    Boston, Massachusetts, 02114, United States

  • Local Institution - 0003

    Houston, Texas, 77030-4009, United States

  • Local Institution - 0004

    Los Angeles, California, 90033, United States

  • Local Institution - 0005

    Portland, Oregon, 97213, United States

  • Local Institution - 0006

    Nashville, Tennessee, 37232, United States

  • Local Institution - 0008

    Atlanta, Georgia, 30322, United States

  • Local Institution - 0010

    Madrid, 28050, Spain

  • Local Institution - 0011

    Seville, 41013, Spain

  • Local Institution - 0012

    Madrid, Madrid, 28009, Spain

  • Local Institution - 0013

    Pittsburgh, Pennsylvania, 15232, United States

  • Local Institution - 0016

    Toronto, Ontario, M5G 1X5, Canada

  • Local Institution - 0018

    Brussels, 1090, Belgium

  • Local Institution - 0019

    Brussels, 1000, Belgium

  • Local Institution - 0020

    Leuven, 3000, Belgium

  • Local Institution - 0022

    Dublin, 0, Ireland

  • Local Institution - 0023

    Dublin, 0, Ireland

  • Local Institution - 0024

    Durham, North Carolina, 27710, United States

  • Local Institution - 0025

    Paris, 75571, France

  • Local Institution - 0027

    Edmonton, Alberta, T6G 1Z2, Canada

  • Local Institution - 0028

    Gilbert, Arizona, 85234, United States

  • Local Institution - 0029

    Winston-Salem, North Carolina, 27103, United States

  • Local Institution - 0030

    Candiolo, Torino, 10060, Italy

  • Local Institution - 0032

    Padova, Padova, Italy

  • Local Institution - 0033

    Galway, 0, Ireland

  • Local Institution - 0034

    Minneapolis, Minnesota, 55407, United States

  • Local Institution - 0035

    Modena, 41124, Italy

  • Local Institution - 0036

    Boston, Massachusetts, 02114, United States

  • Local Institution - 0037

    Melbourne, Victoria, 3000, Australia

  • Local Institution - 0039

    Southport, Queensland, 4215, Australia

  • Local Institution - 0040

    Westmead, New South Wales, 2145, Australia

  • Local Institution - 0041

    Allentown, Pennsylvania, 18103, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.