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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Cancers

Treatments: Biological: Ipilimumab; Biological: Nivolumab; Drug: BMS-986301

Study type: Interventional

Funder types: Industry

Identifiers

NCT03956680

2018-003610-41 (EudraCT Number)

CA046-006

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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54 participants in 5 patient groups

Part 1A Group 1: BMS-986301 Monotherapy Intramuscular (IM)

Experimental group

Treatment:

Drug: BMS-986301

Biological: Nivolumab

Biological: Ipilimumab

Part 1A Group 2: BMS-986301 Monotherapy Intratumoral (I-TUMOR) Sub-study

Experimental group

Treatment:

Drug: BMS-986301

Biological: Nivolumab

Biological: Ipilimumab

Part 1A Group 3: BMS-986301 Monotherapy Intravenous (IV) Sub-study

Experimental group

Treatment:

Drug: BMS-986301

Biological: Nivolumab

Biological: Ipilimumab

Part 1B Group 4: Systemic BMS-986301 + Nivolumab + Ipilimumab

Experimental group

Treatment:

Drug: BMS-986301

Biological: Nivolumab

Biological: Ipilimumab

Part 1B Group 5: I-TUMOR BMS-986301 + Nivolumab + Ipilimumab

Experimental group

Treatment:

Drug: BMS-986301

Biological: Nivolumab

Biological: Ipilimumab