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New drug combo shows promise against tough cancers

NCT ID NCT04349267

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-phase trial tested an experimental drug called BMS-986315, alone or combined with other immunotherapies (nivolumab or cetuximab), in 44 people with advanced solid tumors like head and neck, lung, or kidney cancer. The main goals were to check safety and find the right dose. Researchers also looked at whether tumors shrank. The study is complete, but results are not yet widely reported.

What this could mean

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

Active substance
BMS-986315 (an experimental immunotherapy drug)
What this could lead to
If successful, this could point toward a new treatment option for advanced solid tumors like head and neck, lung, or kidney cancer.
What could go wrong
This is an early-phase trial with only 44 participants, so results may not apply broadly. The drug may cause side effects or fail to shrink tumors.

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

44 people

The number who actually took part.

Started

Jul 2020

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: * Participants must have histologic confirmation of advanced (metastatic, recurrent, and/or unresectable) squamous cell carcinoma of the head and neck (SCCHN), nonsmall cell lung cancer (NSCLC), or renal cell cancer (RCC) with measurable disease per RECIST 1.1 * Participants expected to have received standard of care therapies including an available PD-(L)1 inhibitor * Eastern cooperative oncology group performance status of 0 or 1 * Women of childbearing potential must agree to follow methods of contraception Exclusion Criteria: * Participants with active, known or suspected autoimmune disease * Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications * Uncontrolled or significant cardiovascular disease * History of or with active interstitial lung disease or pulmonary fibrosis * Prior participation in anti-natural killer cell receptor (anti-NKG2A) clinical study * 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.

childhood kidney cell carcinoma head and neck squamous cell carcinoma non-small cell lung carcinoma renal cell carcinoma

As listed by the trial registrant

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

Advanced solid tumor

Contacts and locations

Locations

  • Local Institution

    Mexico City, Mexico City, 06100, Mexico

  • Local Institution - 0001

    Germantown, Tennessee, 38138, United States

  • Local Institution - 0004

    Toronto, Ontario, M5G 2M9, Canada

  • Local Institution - 0005

    Montreal, Quebec, H2X 3E4, Canada

  • Local Institution - 0011

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Local Institution - 0013

    Ottawa, K1H 8L6, Canada

  • Local Institution - 0014

    Edmonton, Alberta, T6X 1E8, Canada

  • Local Institution - 0028

    Sioux Falls, South Dakota, 57104, United States

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