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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003610-41 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1A Group 1: BMS-986301 Monotherapy Intramuscular (IM) | Experimental |
| |
| Part 1A Group 2: BMS-986301 Monotherapy Intratumoral (I-TUMOR) Sub-study | Experimental |
| |
| Part 1A Group 3: BMS-986301 Monotherapy Intravenous (IV) Sub-study | Experimental |
| |
| Part 1B Group 4: Systemic BMS-986301 + Nivolumab + Ipilimumab | Experimental |
| |
| Part 1B Group 5: I-TUMOR BMS-986301 + Nivolumab + Ipilimumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986301 | Drug | Specified dose on specified days |
|
| Measure | Description | 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) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0003 | Chicago | Illinois | 60637 | United States | ||
| Local Institution - 0005 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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| Nivolumab | Biological | Specified dose on specified days |
|
|
| Ipilimumab | Biological | Specified dose on specified days |
|
|
| St Louis |
| Missouri |
| 63110 |
| United States |
| Local Institution - 0006 | Pittsburgh | Pennsylvania | 15232-1305 | United States |
| Local Institution - 0002 | Nashville | Tennessee | 37232 | United States |
| Local Institution - 0001 | Toronto | Ontario | M5G 1Z5 | Canada |
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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