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RecruitingInterventionalPhase 1/Phase 2

A Phase 1/2 Study of BMS-986482 as Monotherapy or Combination Therapy in Participants With Advanced Solid Tumors

NCT ID: NCT06697197Sponsor: Bristol-Myers SquibbLast updated: 2026-02-03

Summary

The purpose of this study is to test the safety and efficacy of BMS-986482 alone and as combination therapy in participants with advanced solid tumors.

Arms & interventions

  • DrugBMS-986482

    Specified dose on specified days

  • DrugNivolumab and rHuPH20

    Specified dose on specified days

  • DrugNivolumab/relatlimab/rHuPH20

    Specified dose on specified days

  • DrugBevacizumab

    Specified dose on specified days

Outcome measures

Primary

  • Number of participants with Adverse Events (AEs) as assessed by National Cancer Institute -Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0)

    Time frame: Up to 135 days post last treatment visit

  • Number of participants with Serious AEs (SAEs) as assessed by NCI-CTCAE v5.0

    Time frame: Up to 135 days post last treatment visit

  • Number of participants with AEs meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria as assessed by NCI-CTCAE v5.0

    Time frame: Up to Day 28

  • Number of participants with AEs leading to discontinuation as assessed by NCI-CTCAE v5.0

    Time frame: Up to 135 days post last treatment visit

  • Number of deaths as assessed by NCI-CTCAE v5.0

    Time frame: Through study completion (Up to 4 years)

Secondary

  • Concentration at the end of infusion (Cmax)

    Time frame: Up to 135 days post last treatment visit

  • Time of maximum observed concentration (Tmax)

    Time frame: Up to 135 days post last treatment visit

  • Area under the concentration-time curve in one dosing interval (AUC(TAU))

    Time frame: Up to 135 days post last treatment visit

  • Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) as assessed by Investigator

    Time frame: Up to 135 days post last treatment visit

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * All participants must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy measurable by RECIST v1.1, and have received, be refractory to, ineligible for, intolerant of, or refused existing therapy(ies) known to provide clinical benefit for the condition of the participant. * Participant must be ≥ 18 years or the legal age of consent in the jurisdiction in which the study is taking place, inclusive, at the time of signing the ICF. Exclusion Criteria: * History of life threatening immune mediated toxicity related to prior T-cell agonist or checkpoint inhibitor therapy, except those that are unlikely to re-occur with standard countermeasures. * Any significant acute or chronic medical illness which would interfere with study intervention or follow-up in the opinion of the investigator. * Other protocol-defined Inclusion/Exclusion criteria apply.

Study locations (7)

University of California, Irvine (UCI) Health - UC Irvine Medical Center

Irvine, California, 92612

Recruiting
Warren Chow, Site 0005 · Contact

The Angeles Clinic and Research Institute - West Los Angeles Office

Los Angeles, California, 90025

Recruiting
Omid Hamid, Site 0030 · Contact

Local Institution - 0008

Aurora, Colorado, 80045

Not Yet Recruiting
Site 0008 · Contact

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601

Recruiting
Martin Gutierrez, Site 0009 · Contact

Northwell Health/ RJ Zuckerberg Cancer Center

Lake Success, New York, 11042

Recruiting
Nagashree Seetharamu, Site 0007 · Contact

Levine Cancer Institute

Charlotte, North Carolina, 28204

Recruiting
Asim Amin, Site 0011 · Contact

Fred Hutchinson Cancer Center

Seattle, Washington, 98109

Recruiting
Cristina Rodriguez, Site 0010 · Contact
A Study of BMS-986482 Alone or as Combination Therapy in Participants With Advanced Solid Tumors | Cancerify