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New immunotherapy combo shows promise for advanced cancers

NCT ID NCT03369223

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an experimental drug called BMS-986249, either alone or combined with the immunotherapy nivolumab (Opdivo), in 356 people with advanced solid tumors. The main goals were to check safety and find the right dose. Researchers also looked at whether the tumors shrank. The trial has completed, and results will help guide future studies.

What this could mean

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

Active substance
BMS-986249 (an experimental immunotherapy) and nivolumab (Opdivo)
What this could lead to
If successful, this could lead to a new treatment option for people with advanced solid tumors that have not responded to other therapies.
What could go wrong
This is an early-phase trial focused on safety, so it is not yet known if the drug combination works better than existing treatments. Side effects may be serious.

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

356 people

The number who actually took part.

Started

Dec 2017

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: * Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease or metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on CT/MRI for prostate cancer and have at least 1 lesion accessible for biopsy. For Part 2B participants with HCC, intermediate disease is allowed. * Eastern Cooperative Oncology Group Performance Status of 0 or 1 * Must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to tumor type, if such a therapy exists * Prior anti-cancer treatments such as chemotherapy, radiotherapy, or hormonal are permitted for some participants * Willing and able to comply with all study procedures Exclusion Criteria: * Primary central nervous system (CNS) malignancies, tumors with CNS metastases as the only site of disease or active brain metastases will be excluded * Other active malignancy requiring concurrent intervention * Prior organ allograft * Active, known, or suspected autoimmune disease Other protocol-defined inclusion/exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

cancer neoplasm

As listed by the trial registrant

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

Advanced cancer

Contacts and locations

Locations

  • Local Institution - 0001

    Hackensack, New Jersey, 07601, United States

  • Local Institution - 0002

    New York, New York, 10032, United States

  • Local Institution - 0003

    New York, New York, 10065, United States

  • Local Institution - 0004

    Philadelphia, Pennsylvania, 19104, United States

  • Local Institution - 0005

    Aurora, Colorado, 80045, United States

  • Local Institution - 0006

    Denver, Colorado, 80218, United States

  • Local Institution - 0007

    Norfolk, Virginia, 23502, United States

  • Local Institution - 0008

    Greenville, South Carolina, 29605, United States

  • Local Institution - 0009

    Dallas, Texas, 75246, United States

  • Local Institution - 0010

    Austin, Texas, 78705-1165, United States

  • Local Institution - 0011

    Tyler, Texas, 75702, United States

  • Local Institution - 0012

    Leesburg, Virginia, 20176, United States

  • Local Institution - 0013

    Eugene, Oregon, 97401, United States

  • Local Institution - 0014

    Adelaide, South Australia, 5000, Australia

  • Local Institution - 0015

    North Sydney, New South Wales, 2060, Australia

  • Local Institution - 0016

    San Antonio, Texas, 78240, United States

  • Local Institution - 0017

    Miami, Florida, 33176, United States

  • Local Institution - 0018

    Vancouver, Washington, 98684, United States

  • Local Institution - 0020

    Naples, 80131, Italy

  • Local Institution - 0021

    Houston, Texas, 77030, United States

  • Local Institution - 0022

    Madrid, Madrid, Comunidad de, 28027, Spain

  • Local Institution - 0023

    Madrid, 28040, Spain

  • Local Institution - 0024

    Baltimore, Maryland, 21287, United States

  • Local Institution - 0025

    Frankston, Victoria, 3199, Australia

  • Local Institution - 0026

    Edmonton, Alberta, T6G 1Z2, Canada

  • Local Institution - 0029

    Cincinnati, Ohio, 45219, United States

  • Local Institution - 0030

    Essen, 45147, Germany

  • Local Institution - 0031

    Heidelberg, 69120, Germany

  • Local Institution - 0035

    Hamburg, 20251, Germany

  • Local Institution - 0036

    Santiago, Santiago Metropolitan, 8420383, Chile

  • Local Institution - 0037

    Buenos Aires, C1426ANZ, Argentina

  • Local Institution - 0038

    Buenos Aires, Distrito Federal, 1121, Argentina

  • Local Institution - 0039

    Helsinki, 00029, Finland

  • Local Institution - 0040

    Warsaw, 02-781, Poland

  • Local Institution - 0041

    Craiova, 200542, Romania

  • Local Institution - 0042

    Badalona, Barcelona [Barcelona], 08916, Spain

  • Local Institution - 0043

    Málaga, 29010, Spain

  • Local Institution - 0044

    Barcelona, 08035, Spain

  • Local Institution - 0045

    Bucharest, 022328, Romania

  • Local Institution - 0047

    Heidelberg, Victoria, 3084, Australia

  • Local Institution - 0048

    Milan, 20133, Italy

  • Local Institution - 0049

    Siena, 53100, Italy

  • Local Institution - 0050

    Madrid, 28041, Spain

  • Local Institution - 0052

    CABA, Distrito Federal, C1430, Argentina

  • Local Institution - 0056

    Ottawa, Ontario, K1H 8L6, Canada

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