An Investigational Immunotherapy Study of BMS-986301 Alone or in Combination With Nivolumab, and Ipilimumab in Participants With Advanced Solid Cancers

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I Study of BMS-986301 Monotherapy and Combination Therapy With Nivolumab and Ipilimumab in Participants With Advanced Solid Cancers

Conditions
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Advanced Solid Cancers

Intervention / Treatment
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* Drug: BMS-986301
* Biological: Nivolumab
* Biological: Ipilimumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1A Group 1: BMS-986301 Monotherapy Intramuscular (IM)<br> | Drug: BMS-986301<br>* Specified dose on specified days<br>Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: OPDIVO;Biological: Ipilimumab<br>* Specified dose on specified days<br>* Other names: YERVOY;|
| Experimental: Part 1A Group 2: BMS-986301 Monotherapy Intratumoral (I-TUMOR) Sub-study<br> | Drug: BMS-986301<br>* Specified dose on specified days<br>Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: OPDIVO;Biological: Ipilimumab<br>* Specified dose on specified days<br>* Other names: YERVOY;|
| Experimental: Part 1A Group 3: BMS-986301 Monotherapy Intravenous (IV) Sub-study<br> | Drug: BMS-986301<br>* Specified dose on specified days<br>Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: OPDIVO;Biological: Ipilimumab<br>* Specified dose on specified days<br>* Other names: YERVOY;|
| Experimental: Part 1B Group 4: Systemic BMS-986301 + Nivolumab + Ipilimumab<br> | Drug: BMS-986301<br>* Specified dose on specified days<br>Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: OPDIVO;Biological: Ipilimumab<br>* Specified dose on specified days<br>* Other names: YERVOY;|
| Experimental: Part 1B Group 5: I-TUMOR BMS-986301 + Nivolumab + Ipilimumab<br> | Drug: BMS-986301<br>* Specified dose on specified days<br>Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: OPDIVO;Biological: Ipilimumab<br>* Specified dose on specified days<br>* Other names: YERVOY;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) |