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

NCT06697197 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: CA236-00012024-516602-28U1111-1309-0886
• Study Type: interventional
• Target: 413
• Locations: 9 countries
• Sites: 21

Brief 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.

Conditions

Advanced Solid Tumors

Keywords

Immuno-oncology; Regulatory T cells; Tregs

Outcome Measures

Primary Outcomes (5)

• 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)

  Up to 135 days post last treatment visit

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

  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

  Up to Day 28

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

  Up to 135 days post last treatment visit

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

  Through study completion (Up to 4 years)

Secondary Outcomes (4)

• Concentration at the end of infusion (Cmax)

  Up to 135 days post last treatment visit

• Time of maximum observed concentration (Tmax)

  Up to 135 days post last treatment visit

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

  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

  Up to 135 days post last treatment visit

Study Arms (9)

Part 1A

EXPERIMENTAL

Drug: BMS-986482

Part 1B1

EXPERIMENTAL

Drug: BMS-986482; Drug: Nivolumab and rHuPH20

Part 1B2

EXPERIMENTAL

Drug: BMS-986482; Drug: Nivolumab/relatlimab/rHuPH20

Part 1B3

EXPERIMENTAL

Drug: BMS-986482; Drug: Bevacizumab

Part 1C

EXPERIMENTAL

Drug: BMS-986482

Part 2A

EXPERIMENTAL

Drug: BMS-986482

Part 2B1

EXPERIMENTAL

Drug: BMS-986482; Drug: Nivolumab and rHuPH20

Part 2B2

EXPERIMENTAL

Drug: BMS-986482; Drug: Nivolumab/relatlimab/rHuPH20

Part 2B3

EXPERIMENTAL

Drug: BMS-986482; Drug: Bevacizumab

Interventions

Nivolumab/relatlimab/rHuPH20 DRUG

Specified dose on specified days

Also known as: BMS-986213

Part 1B2; Part 2B2

Bevacizumab DRUG

Specified dose on specified days

Part 1B3; Part 2B3

BMS-986482 DRUG

Specified dose on specified days

Part 1A; Part 1B1; Part 1B2; Part 1B3; Part 1C; Part 2A; Part 2B1; Part 2B2; Part 2B3

Nivolumab and rHuPH20 DRUG

Specified dose on specified days

Also known as: BMS-986298

Part 1B1; Part 2B1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (21)

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

Irvine, California, 92612, United States

RECRUITING

The Angeles Clinic and Research Institute - West Los Angeles Office

Los Angeles, California, 90025, United States

RECRUITING

Local Institution - 0008

Aurora, Colorado, 80045, United States

NOT YET RECRUITING

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Northwell Health/ RJ Zuckerberg Cancer Center

Lake Success, New York, 11042, United States

RECRUITING

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

UZ Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

Rigshospitalet

Copenhagen, Capital Region, DK-2100, Denmark

RECRUITING

Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

Marseille, Bouches-du-Rhône, 13385, France

RECRUITING

Gustave Roussy

Villejuif, Paris, 94800, France

RECRUITING

General Hospital of Athens "Laiko"

Athens, Attikí, 11527, Greece

RECRUITING

Papageorgiou General Hospital of Thessaloniki

Thessaloniki, Thessaloníki, 564 29, Greece

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Lombardy, 20133, Italy

RECRUITING

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

RECRUITING

Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL)

Amsterdam, North Holland, 1066 CX, Netherlands

RECRUITING

Erasmus Medisch Centrum

Rotterdam, 3015 GD, Netherlands

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], 08035, Spain

RECRUITING

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Hospital Universitario HM Sanchinarro

Madrid, 28050, Spain

RECRUITING

Karolinska Universitetssjukhuset Solna

Solna, Stockholms Län [se-01], 171 64, Sweden

RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

Nivolumab; Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

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

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: February 17, 2025
• Primary Completion (Estimated): January 4, 2029
• Study Completion (Estimated): January 5, 2029
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

DK (1); FR (2); IT (2); NL (2); GR (2); ES (3); SE (1); BE (1); US (7)