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New cocktail of cancer drugs tested for Tough-to-Treat colorectal cancer

NCT ID NCT03377361

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a combination of nivolumab (Opdivo) and trametinib (Mekinist), with or without ipilimumab (Yervoy), in 325 people whose colorectal cancer had spread and had not responded to prior treatments. The main goals were to check safety and see if the drugs could shrink tumors. The trial has been completed, and results will help determine if this approach is worth further study.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nivolumab (Opdivo), trametinib (Mekinist), ipilimumab (Yervoy), regorafenib
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced colorectal cancer that has not responded to prior therapy.
What could go wrong
This was an early-phase trial (Phase 1/2) focused on safety and dosing, so it is not yet clear if the combination works better than existing treatments. Side effects from combining these drugs may be significant.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

325 people

The number who actually took part.

Started

Jan 2018

Finished

Nov 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: * Histologically or cytologically confirmed previously treated metastatic colorectal cancer with adenocarcinoma histology and in Stage IV per American Joint Committee on Cancer (version 4.0) at study entry * Microsatellite status should be performed per local standard of practice, immunohistochemistry (IHC) and/or PCR. If IHC results are equivocal, PCR is required for determining microsatellite stable (MSS) status * Must have measurable disease per RECIST 1.1. Participants with lesions in a previously irradiated field as the sole site of measurable disease will be permitted to enroll provided the lesion(s) have demonstrated clear progression and can be measured accurately * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 at screening and on cycle 1 day 1 (C1D1) Exclusion Criteria: * BRAF V600 mutant colorectal cancer * Active brain metastases or leptomeningeal metastases * Active, known or suspected autoimmune disease * Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration * History of interstitial lung disease or pneumonitis * Prior treatment with immune checkpoint inhibitors and mitogen-activated protein kinase enzymes (MEK) inhibitors * History of allergy or hypersensitivity to study drug components Other protocol defined inclusion/exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal carcinoma colorectal neoplasm

As listed by the trial registrant

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

Colorectal cancer Colorectal carcinoma Colorectal neoplasm Colorectal tumors

Contacts and locations

Locations

  • Local Institution

    Woluwe-Saint-Lambert, 1200, Belgium

  • Local Institution - 0001

    San Francisco, California, 94158, United States

  • Local Institution - 0002

    Madison, Wisconsin, 53792-0001, United States

  • Local Institution - 0003

    Philadelphia, Pennsylvania, 19104, United States

  • Local Institution - 0004

    Hanover, 30625, Germany

  • Local Institution - 0022

    Birmingham, Alabama, 35249, United States

  • Local Institution - 0027

    Los Angeles, California, 90033, United States

  • Local Institution - 0028

    Baltimore, Maryland, 21287, United States

  • Local Institution - 0029

    Charlotte, North Carolina, 28204, United States

  • Local Institution - 0043

    Southport, Queensland, 4215, Australia

  • Local Institution - 0044

    Blacktown, New South Wales, 2148, Australia

  • Local Institution - 0051

    Madrid, 28041, Spain

  • Local Institution - 0052

    Barcelona, 08035, Spain

  • Local Institution - 0055

    Clayton, Victoria, 0, Australia

  • Local Institution - 0067

    Los Angeles, California, 90089, United States

  • Local Institution - 0068

    Elizabeth Vale, South Australia, 05112, Australia

  • Local Institution - 0069

    Heidelberg, Victoria, 3084, Australia

  • Local Institution - 0070

    Toronto, Ontario, M5G 2M9, Canada

  • Local Institution - 0071

    Brno, 65653, Czechia

  • Local Institution - 0072

    Olomouc, Olomouc Region, 779 00, Czechia

  • Local Institution - 0073

    Hradec Králové, 500 05, Czechia

  • Local Institution - 0076

    Ottawa, K1H 8L6, Canada

  • Local Institution - 0077

    Montreal, Quebec, H2X 0A9, Canada

  • Local Institution - 0079

    Badalona, Barcelona [Barcelona], 08916, Spain

  • Local Institution - 0080

    Pamplona, Navarre, 31009, Spain

  • Local Institution - 0092

    Padova, 35128, Italy

  • Local Institution - 0093

    Milan, 20133, Italy

  • Local Institution - 0094

    Rozzano, 20089, Italy

  • Local Institution - 0095

    Catania, 95124, Italy

  • Local Institution - 0096

    Seville, 41013, Spain

  • Local Institution - 0100

    Lancaster, Pennsylvania, 17604, United States

  • Local Institution - 0101

    Temple, Texas, 76508, United States

  • Local Institution - 0103

    St Louis, Missouri, 63110, United States

  • Local Institution - 0104

    New York, New York, 10016, United States

  • Local Institution - 0107

    Gainesville, Florida, 32610, United States

  • Local Institution - 0111

    Miami, Florida, 33136, United States

  • Local Institution - 0113

    Edmonton, Alberta, T6G 1Z2, Canada

  • Local Institution - 0114

    Madrid, 28007, Spain

  • Local Institution - 0115

    Madrid, 28050, Spain

  • Local Institution - 0116

    Hattiesburg, Mississippi, 39401-7233, United States

  • Local Institution - 0117

    Santiago, Santiago Metropolitan, 000000, Chile

  • Local Institution - 0118

    Santiago, Santiago Metropolitan, 8420383, Chile

  • Local Institution - 0119

    Buenos Aires, 1431, Argentina

  • Local Institution - 0120

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina

  • Local Institution - 0122

    Buenos Aires, Distrito Federal, C1096AAS, Argentina

  • Local Institution - 0123

    Buenos Aires, Distrito Federal, 1181, Argentina

  • Thomas Jefferson University - Clinical Research Institute

    Philadelphia, Pennsylvania, 19107, United States

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