A Phase 1/2 Study of BMS-986315 as Monotherapy and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors

CA047-004

The purpose of this study is to evaluate BMS-986315 alone and in combination with nivolumab or cetuximab in participants with advanced solid tumors.

2020-07-14

2024-04-01

2025-05-30

Active (not recruiting)

Early phase I

308

Inclusion Criteria: * Participants must have histologic confirmation of advanced (metastatic, recurrent, and/or unresectable) squamous cell carcinoma of the head and neck (SCCHN), nonsmall cell lung cancer (NSCLC), or renal cell cancer (RCC) with measurable disease per RECIST 1.1 * Participants expected to have received standard of care therapies including an available PD-(L)1 inhibitor * Eastern cooperative oncology group performance status of 0 or 1 * Women of childbearing potential must agree to follow methods of contraception Exclusion Criteria: * Participants with active, known or suspected autoimmune disease * Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications * Uncontrolled or significant cardiovascular disease * History of or with active interstitial lung disease or pulmonary fibrosis * Prior participation in anti-natural killer cell receptor (anti-NKG2A) clinical study * History of allergy or hypersensitivity to study drug components Other protocol-defined inclusion/exclusion criteria apply

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 308, 'type': 'ESTIMATED'}}

2024-02-12