Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Biological: cetuximab; Biological: BMS-986315; Biological: nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04349267

CA047-004

Details and patient eligibility

About

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

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 3 patient groups

BMS-986315

Experimental group

Treatment:

Biological: BMS-986315

BMS-986315 + nivolumab

Experimental group

Treatment:

Biological: nivolumab

Biological: BMS-986315

BMS-986315 + cetuximab

Experimental group

Treatment:

Biological: BMS-986315

Biological: cetuximab