A Phase 1/2 Study of BMS-986482 as Monotherapy or Combination Therapy in Participants With Advanced Solid Tumors
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.
Arms & interventions
- DrugBMS-986482
Specified dose on specified days
- DrugNivolumab and rHuPH20
Specified dose on specified days
- DrugNivolumab/relatlimab/rHuPH20
Specified dose on specified days
- DrugBevacizumab
Specified dose on specified days
Outcome measures
Primary
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
Number of participants with Serious AEs (SAEs) as assessed by NCI-CTCAE v5.0
Time frame: 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
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
Number of deaths as assessed by NCI-CTCAE v5.0
Time frame: Through study completion (Up to 4 years)
Secondary
Concentration at the end of infusion (Cmax)
Time frame: Up to 135 days post last treatment visit
Time of maximum observed concentration (Tmax)
Time frame: 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
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
Eligibility criteria
Study locations (7)
University of California, Irvine (UCI) Health - UC Irvine Medical Center
Irvine, California, 92612
The Angeles Clinic and Research Institute - West Los Angeles Office
Los Angeles, California, 90025
Local Institution - 0008
Aurora, Colorado, 80045
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
Northwell Health/ RJ Zuckerberg Cancer Center
Lake Success, New York, 11042
Levine Cancer Institute
Charlotte, North Carolina, 28204
Fred Hutchinson Cancer Center
Seattle, Washington, 98109