A Study of BMS-986482 Alone or as Combination Therapy in Participants With Advanced Solid Tumors
- Conditions
- Advanced Solid Tumors
- Interventions
- Registration Number
- NCT06697197
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 413
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1A BMS-986482 - Part 1B1 BMS-986482 - Part 1B1 Nivolumab and rHuPH20 - Part 1B2 BMS-986482 - Part 1B2 Nivolumab/relatlimab/rHuPH20 - Part 1B3 BMS-986482 - Part 1B3 Bevacizumab - Part 1C BMS-986482 - Part 2A BMS-986482 - Part 2B1 BMS-986482 - Part 2B1 Nivolumab and rHuPH20 - Part 2B2 BMS-986482 - Part 2B2 Nivolumab/relatlimab/rHuPH20 - Part 2B3 BMS-986482 - Part 2B3 Bevacizumab -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Related Research Topics
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Trial Locations
- Locations (21)
Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States
Local Institution - 0005
🇺🇸Irvine, California, United States
Local Institution - 0030
🇺🇸Los Angeles, California, United States
Local Institution - 0008
🇺🇸Aurora, Colorado, United States
John Theurer Cancer Center at Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Northwell Health/ RJ Zuckerberg Cancer Center
🇺🇸Lake Success, New York, United States
Fred Hutchinson Cancer Center
🇺🇸Seattle, Washington, United States
Local Institution - 0017
🇧🇪Gent, Oost-Vlaanderen, Belgium
Local Institution - 0022
🇩🇰Copenhagen, Hovedstaden, Denmark
Local Institution - 0016
🇫🇷Marseille, Bouches-du-Rhône, France
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