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

NCT06697197 · tracked via the Priya Life Science Denmark tracker

Sponsor

Bristol-Myers Squibb

Phase

Phase 1/2

Started

2025-02-17

Last updated

2026-02-03

Condition(s) studied

Advanced Solid Tumors

Investigational drug(s) / intervention(s)

BMS-986482Nivolumab and rHuPH20 →Nivolumab/relatlimab/rHuPH20 →Bevacizumab →

BMS-986482: Specified dose on specified days

Nivolumab and rHuPH20: Specified dose on specified days

Nivolumab/relatlimab/rHuPH20: Specified dose on specified days

Bevacizumab: Specified dose on specified days

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

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)

Trial sites (21)

Facility	City	Region	Status
University of California, Irvine (UCI) Health - UC Irvine Medical Center	Irvine	California	Recruiting
The Angeles Clinic and Research Institute - West Los Angeles Office	Los Angeles	California	Recruiting
Local Institution - 0008	Aurora	Colorado	Not Yet Recruiting
John Theurer Cancer Center at Hackensack University Medical Center	Hackensack	New Jersey	Recruiting
Northwell Health/ RJ Zuckerberg Cancer Center	Lake Success	New York	Recruiting
Levine Cancer Institute	Charlotte	North Carolina	Recruiting
Fred Hutchinson Cancer Center	Seattle	Washington	Recruiting
UZ Gent	Ghent	Oost-Vlaanderen	Recruiting
Rigshospitalet	Copenhagen	Capital Region	Recruiting
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone	Marseille	Bouches-du-Rhône	Recruiting
Gustave Roussy	Villejuif	Paris	Recruiting
General Hospital of Athens "Laiko"	Athens	Attikí	Recruiting
Papageorgiou General Hospital of Thessaloniki	Thessaloniki	Thessaloníki	Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori	Milan	Lombardy	Recruiting
Istituto Clinico Humanitas	Rozzano	Milano	Recruiting
Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL)	Amsterdam	North Holland	Recruiting
Erasmus Medisch Centrum	Rotterdam	Netherlands	Recruiting
Hospital Universitari Vall d'Hebron	Barcelona	Barcelona [Barcelona]	Recruiting
Clinica Universidad de Navarra	Pamplona	Navarre	Recruiting
Hospital Universitario HM Sanchinarro	Madrid	Spain	Recruiting
Karolinska Universitetssjukhuset Solna	Solna	Stockholms Län [se-01]	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06697197 on ClinicalTrials.gov ↗ ← All trials in Denmark