A Study of BMS-986482 Alone or as Combination Therapy in Participants With Advanced Solid Tumors

January 30, 2026 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

413

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Belgium
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • UZ Gent
        • Contact:
          • Brant Delafontaine, Site 0017
          • Phone Number: +3293320000
  • Denmark
    • Capital Region
      • Copenhagen, Capital Region, Denmark, DK-2100
        • Recruiting
        • Rigshospitalet
        • Contact:
          • Kristoffer Rohrberg, Site 0022
          • Phone Number: +4535456353
  • France
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, France, 13385
        • Recruiting
        • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
        • Contact:
          • Caroline Gaudy, Site 0016
          • Phone Number: +33491380000
    • Paris
      • Villejuif, Paris, France, 94800
        • Recruiting
        • Gustave Roussy
        • Contact:
          • Anna PATRIKIDOU, Site 0012
          • Phone Number: +3314214211
  • Greece
    • Attikí
      • Athens, Attikí, Greece, 11527
        • Recruiting
        • General Hospital of Athens "Laiko"
        • Contact:
          • Dimitrios Ziogas, Site 0038
          • Phone Number: 306936490499
    • Thessaloníki
      • Thessaloniki, Thessaloníki, Greece, 564 29
        • Recruiting
        • Papageorgiou General Hospital of Thessaloniki
        • Contact:
          • Georgios Lazaridis, Site 0039
          • Phone Number: 302313323959
  • Italy
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori
        • Contact:
          • Massimo Di Nicola, Site 0037
          • Phone Number: 0223902506
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Recruiting
        • Istituto Clinico Humanitas
        • Contact:
          • Matteo Simonelli, Site 0036
          • Phone Number: +390282244559
  • Netherlands
      • Rotterdam, Netherlands, 3015 GD
        • Recruiting
        • Erasmus Medisch Centrum
        • Contact:
          • Sander Bins, Site 0028
          • Phone Number: 3110107040962
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1066 CX
        • Recruiting
        • Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL)
        • Contact:
          • Tim Schutte, Site 0018
          • Phone Number: +3120-5129111
  • Spain
      • Madrid, Spain, 28050
        • Recruiting
        • Hospital Universitario HM Sanchinarro
        • Contact:
          • Emiliano Calvo, Site 0034
          • Phone Number: +34934894304
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
          • Elena Garralda Cabanas, Site 0033
          • Phone Number: 349327460004910
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Recruiting
        • Clinica Universidad de Navarra
        • Contact:
          • Ignacio Melero Bermejo, Site 0035
          • Phone Number: 34948255400
  • Sweden
    • Stockholms Län [se-01]
      • Solna, Stockholms Län [se-01], Sweden, 171 64
        • Recruiting
        • Karolinska Universitetssjukhuset Solna
        • Contact:
          • Lisa Liu, Site 0023
          • Phone Number: 46851770000
  • United States
    • California
      • Irvine, California, United States, 92612
        • Recruiting
        • University of California, Irvine (UCI) Health - UC Irvine Medical Center
        • Contact:
          • Warren Chow, Site 0005
          • Phone Number: 626-372-7121
      • Los Angeles, California, United States, 90025
        • Recruiting
        • The Angeles Clinic and Research Institute - West Los Angeles Office
        • Contact:
          • Omid Hamid, Site 0030
          • Phone Number: 310-231-2121
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Not yet recruiting
        • Local Institution - 0008
        • Contact:
          • Site 0008
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • John Theurer Cancer Center at Hackensack University Medical Center
        • Contact:
          • Martin Gutierrez, Site 0009
          • Phone Number: 551-996-5863
    • New York
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Northwell Health/ RJ Zuckerberg Cancer Center
        • Contact:
          • Nagashree Seetharamu, Site 0007
          • Phone Number: 917-574-8494
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Levine Cancer Institute
        • Contact:
          • Asim Amin, Site 0011
          • Phone Number: 980-442-2000
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Center
        • Contact:
          • Cristina Rodriguez, Site 0010
          • Phone Number: 206-288-6748

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 2A
Drug: BMS-986482
Specified dose on specified days
Experimental: Part 1A
Drug: BMS-986482
Specified dose on specified days
Experimental: Part 1B1
Drug: BMS-986482
Specified dose on specified days
Drug: Nivolumab and rHuPH20
Specified dose on specified days
Other Names:
  • BMS-986298
Experimental: Part 1B2
Drug: BMS-986482
Specified dose on specified days
Drug: Nivolumab/relatlimab/rHuPH20
Specified dose on specified days
Other Names:
  • BMS-986213
Experimental: Part 1B3
Drug: Bevacizumab
Specified dose on specified days
Drug: BMS-986482
Specified dose on specified days
Experimental: Part 1C
Drug: BMS-986482
Specified dose on specified days
Experimental: Part 2B1
Drug: BMS-986482
Specified dose on specified days
Drug: Nivolumab and rHuPH20
Specified dose on specified days
Other Names:
  • BMS-986298
Experimental: Part 2B2
Drug: BMS-986482
Specified dose on specified days
Drug: Nivolumab/relatlimab/rHuPH20
Specified dose on specified days
Other Names:
  • BMS-986213
Experimental: Part 2B3
Drug: Bevacizumab
Specified dose on specified days
Drug: BMS-986482
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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)
Through study completion (Up to 4 years)

Secondary Outcome Measures

Outcome Measure
Time Frame
Concentration at the end of infusion (Cmax)
Time Frame: Up to 135 days post last treatment visit
Up to 135 days post last treatment visit
Time of maximum observed concentration (Tmax)
Time Frame: Up to 135 days post last treatment visit
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
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
Up to 135 days post last treatment visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2025

Primary Completion (Estimated)

January 4, 2029

Study Completion (Estimated)

January 5, 2029

Study Registration Dates

First Submitted

November 18, 2024

First Submitted That Met QC Criteria

November 18, 2024

First Posted (Actual)

November 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA236-0001
  • 2024-516602-28 (Other Identifier: EU CTR)
  • U1111-1309-0886 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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