Advanced Solid Cancers
Conditions
Brief summary
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.
Interventions
DRUGBMS-986301
Specified dose on specified days
BIOLOGICALNivolumab
Specified dose on specified days
BIOLOGICALIpilimumab
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed advanced unresectable/metastatic malignancy of the squamous cell carcinoma of the head and neck (HNSCC), non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), triple negative breast cancer (TNBC), and urothelial carcinoma (UCC), that are refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant * Must have experienced radiographically documented progressive disease on or after the most recent therapy * Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 * Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial
Exclusion criteria
* Primary central nervous system (CNS) malignancy * Other active malignancy requiring concurrent intervention * Uncontrolled or significant cardiovascular disease Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of dose-limiting toxicity (DLTs) | Cycle 1 (28 days) |
| Incidence of adverse events (AEs) | From Baseline until study exit (up to approximately 2 years) |
| Incidence of serious adverse events (SAEs) | From Baseline until study exit (up to approximately 2 years) |
| Incidence of AEs leading to discontinuation | From Baseline until study exit (up to approximately 2 years) |
| Incidence of deaths | From Baseline until study exit (up to approximately 2 years) |
| Incidence of clinically significant changes in clinical laboratory results: Hematology tests | From Baseline until disease progression (approximately 2 years) |
| Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests | From Baseline until disease progression (approximately 2 years) |
| Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests | From Baseline until disease progression (approximately 2 years) |
Countries
Canada, United States
Outcome results
None listed