A Study of BMS-986416 With and Without Nivolumab in Select Solid Tumors

Study summary

The purpose of this study is to evaluate the safety, tolerability, drug effects, drug levels and preliminary antitumor activity of BMS-986416 when administered alone and in combination with Nivolumab in participants with select advanced solid tumors.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedBMS-986416 and Nivolumab

The study team can explain what participation involves.

Who it may be forAdvanced Solid Tumors

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 9, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?19 U.S. locations

Locations may change over time.

Who runs it?Bristol-Myers Squibb

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Bristol-Myers Squibb
Interventions being studied: Drug: BMS-986416; Drug: Nivolumab

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach

Immunotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Participants with histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent select solid tumor
Eligible tumor types Non-small cell lung cancer (NSCLC), Urothelial carcinoma (UC), Squamous cell carcinoma of the head and neck (SCCHN), Hepatocellular carcinoma (HCC), Microsatellite-stable colorectal carcinoma (MSS CRC), or Pancreatic ductal adenocarcinoma (PDAC)
Resistant/refractory to or intolerant of existing standard therapies known to provide clinical benefit
Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1)
Disease amenable to serial biopsy

Reasons someone may not be able to joinExclusion criteria

Uncontrolled or significant cardiovascular disease
Known connective tissue disease such as Marfan, Ehlers-Danlos, or Loeys-Dietz syndrome
Medical requirement for chronic anticoagulant or antiplatelet agents (except low-dose aspirin, which is permitted) Other protocol-defined inclusion/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Local Institution - 0006Atlanta, Georgia
Local Institution - 0005Baltimore, Maryland
Local Institution - 0002Hackensack, New Jersey
Local Institution - 0013Cleveland, Ohio
Local Institution - 0003Pittsburgh, Pennsylvania
Local Institution - 0004Houston, Texas
Local Institution - 0021Ciudad Autónoma de Buenos Aires, Buenos Aires
Local Institution - 0027ABB, Buenos Aires F.D.
Local Institution - 0022CABA, Buenos Aires F.D.
Local Institution - 0043Edegem, Antwerpen
Local Institution - 0016Ghent, Oost-Vlaanderen
Local Institution - 0009Edmonton, Alberta

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 9, 2025. Always confirm current availability with the study team.

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