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Cancer combo trial halted early: what went wrong?

NCT ID NCT03446040

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Updated 1 time

Summary

This early-phase study tested an experimental drug called BMS-986258, alone or combined with the immunotherapy nivolumab (Opdivo), in 92 people with advanced solid tumors like lung, kidney, or breast cancer. The main goal was to check safety and find the right dose. However, the trial was terminated early, meaning it stopped before completion, so we don't have full results on how well it worked.

What this could mean

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

Active substance
BMS-986258 (an experimental biologic) and nivolumab (Opdivo, an immunotherapy)
What this could lead to
If it had succeeded, this could have pointed toward a new combination treatment for certain advanced cancers.
What could go wrong
The trial was terminated early, so results are limited. It was a small, early-phase study focused on safety, not effectiveness.

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

92 people

The number who actually took part.

Started

Mar 2018

Finished

Aug 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 confirmation of one of the 5 tumors \[renal cell carcinoma (RCC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), triple negative breast cancer (TNBC)\] (metastatic, recurrent, and/or unresectable), with measurable disease per response evaluation criteria in solid tumors v1.1 (RECIST v1.1) * Eastern Cooperative Oncology Group Performance Status of 0 or 1 * Participants 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 solid tumor histologies * Women must agree to follow specific methods of contraception, if applicable Exclusion Criteria: * Active, known or suspected autoimmune disease * Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy * Other active malignancy requiring concurrent intervention Other protocol-defined inclusion/exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

cancer colorectal cancer head and neck squamous cell carcinoma non-small cell lung carcinoma renal cell carcinoma triple-negative breast carcinoma

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 - 0002

    Germantown, Tennessee, 38138, United States

  • Local Institution - 0004

    Los Angeles, California, 90033, United States

  • Local Institution - 0005

    Pittsburgh, Pennsylvania, 15232, United States

  • Local Institution - 0006

    Los Angeles, California, 90033, United States

  • Local Institution - 0007

    Aurora, Colorado, 80045, United States

  • Local Institution - 0008

    Chuo-ku, Tokyo, 1040045, Japan

  • Local Institution - 0009

    Kobe, Hyōgo, 6500017, Japan

  • Local Institution - 0010

    Grand Rapids, Michigan, 49546, United States

  • Local Institution - 0012

    Lebanon, New Hampshire, 03756, United States

  • Local Institution - 0013

    Westmead, New South Wales, 2145, Australia

  • Local Institution - 0014

    Edmonton, Alberta, T6X 1E8, Canada

  • Local Institution - 0015

    Melbourne, Victoria, 3084, Australia

  • Local Institution - 0016

    Cincinnati, Ohio, 45267, United States

  • Local Institution - 0018

    Ann Arbor, Michigan, 48109-5912, United States

  • Local Institution - 0019

    Vancouver, British Columbia, V5Z 4E6, Canada

  • University Of Iowa Hospitals And Clinics

    Iowa City, Iowa, 52242, United States

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