Advanced Solid Cancers Clinical Trial
Official title:
A Phase I Study of BMS-986301 Monotherapy and Combination Therapy With Nivolumab and Ipilimumab in Participants With Advanced Solid Cancers
| Verified date | May 2024 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 54 |
| Est. completion date | April 17, 2024 |
| Est. primary completion date | April 17, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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/exclusion criteria apply |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Local Institution - 0001 | Toronto | Ontario |
| United States | Local Institution - 0003 | Chicago | Illinois |
| United States | Local Institution - 0002 | Nashville | Tennessee |
| United States | Local Institution - 0006 | Pittsburgh | Pennsylvania |
| United States | Local Institution - 0005 | Saint Louis | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of dose-limiting toxicity (DLTs) | Cycle 1 (28 days) | ||
| Primary | Incidence of adverse events (AEs) | From Baseline until study exit (up to approximately 2 years) | ||
| Primary | Incidence of serious adverse events (SAEs) | From Baseline until study exit (up to approximately 2 years) | ||
| Primary | Incidence of AEs leading to discontinuation | From Baseline until study exit (up to approximately 2 years) | ||
| Primary | Incidence of deaths | From Baseline until study exit (up to approximately 2 years) | ||
| Primary | Incidence of clinically significant changes in clinical laboratory results: Hematology tests | From Baseline until disease progression (approximately 2 years) | ||
| Primary | Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests | From Baseline until disease progression (approximately 2 years) | ||
| Primary | Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests | From Baseline until disease progression (approximately 2 years) |
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|---|---|---|---|
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