A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies

Study summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of BMS-986523 alone and in combination with anti-cancer agents in participants with advanced solid malignancies

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedBMS-986523 and Gemcitabine

Plus 3 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated May 28, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?8 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 / Phase 2
Sponsor: Bristol-Myers Squibb
Interventions being studied: Drug: BMS-986523; Drug: Gemcitabine; Drug: Nab-Paclitaxel; Drug: Cetuximab; Drug: Pembrolizumab

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How this study is categorized

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

Cancer type

Non-small cell lung cancer (NSCLC)→

Treatment approach

Immunotherapy→Chemotherapy→

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 must have a histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with a known Kirsten rat sarcoma viral oncogene homolog (KRAS) alteration (mutation or amplification).
Participants must, for Arm D, have a PD-L1 expression (≥50%).
Participants must have previously received, be ineligible for, or decline (after having been provided adequate information to make an informed decision) the protocol defined standard of care (SoC) treatments.

Reasons someone may not be able to joinExclusion criteria

Participants must not have untreated central nervous system (CNS) metastases.
Participants must not have concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment.
Participants must not have a history of, or any evidence of, interstitial lung disease or active, non-infectious pneumonitis. A history of radiation pneumonitis in the radiation field is permitted.
Participants must not have a history of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).
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

Johns Hopkins HospitalBaltimore, Maryland
NEXT OncologySan Antonio, Texas
START Mountain RegionWest Valley City, Utah
NEXT VirginiaFairfax, Virginia
BC Cancer VancouverVancouver, British Columbia
Princess Margaret Cancer CentreToronto, Ontario
Local Institution - 0006Badalona, Barcelona [Barcelona]
Local Institution - 0008Hortaleza, Madrid

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 28, 2026. Always confirm current availability with the study team.

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