The main purpose of this study is to characterize the safety, tolerability, dose limiting toxicities, best route of administration, maximum tolerated dose, maximum administered dose, or alternative dose of BMS-986301 alone or in combination with nivolumab and ipilimumab in participants with cancers that have failed to respond to T cell checkpoint inhibiting antibodies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Local Institution - 0003
Chicago, Illinois, United States
Local Institution - 0005
St Louis, Missouri, United States
Local Institution - 0006
Pittsburgh, Pennsylvania, United States
Local Institution - 0002
Nashville, Tennessee, United States
Incidence of dose-limiting toxicity (DLTs)
Time frame: Cycle 1 (28 days)
Incidence of adverse events (AEs)
Time frame: From Baseline until study exit (up to approximately 2 years)
Incidence of serious adverse events (SAEs)
Time frame: From Baseline until study exit (up to approximately 2 years)
Incidence of AEs leading to discontinuation
Time frame: From Baseline until study exit (up to approximately 2 years)
Incidence of deaths
Time frame: From Baseline until study exit (up to approximately 2 years)
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time frame: From Baseline until disease progression (approximately 2 years)
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time frame: From Baseline until disease progression (approximately 2 years)
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time frame: From Baseline until disease progression (approximately 2 years)
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Local Institution - 0001
Toronto, Ontario, Canada