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NCT Number: NCT06697197

A Study of BMS-986482 Alone or as 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.

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

UZ Gent, Ghent, Oost-Vlaanderen, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986482

Drug

Specified dose on specified days

Nivolumab and rHuPH20

Drug

Specified dose on specified days

Other names: BMS-986298

Nivolumab/relatlimab/rHuPH20

Drug

Specified dose on specified days

Other names: BMS-986213

Bevacizumab

Drug

Specified dose on specified days

Primary outcomes

  1. 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

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

    Time frame: Up to 135 days post last treatment visit

  3. 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

  4. 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

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

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

Secondary outcomes

  1. Concentration at the end of infusion (Cmax)

    Time frame: Up to 135 days post last treatment visit

  2. Time of maximum observed concentration (Tmax)

    Time frame: Up to 135 days post last treatment visit

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

    Time frame: Up to 135 days post last treatment visit

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

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

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Nov 20, 2024
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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