A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 2

Conditions: Melanoma

Treatments: Drug: nivolumab+rHuPH20; Drug: relatlimab+nivolumab; Drug: relatlimab+nivolumab+rHuPH20; Drug: nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06101134

U1111-1289-5947 (Other Identifier)

CA224-1044

2023-504515-33-00 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to assess the patient's preference for nivolumab subcutaneous (SC) or nivolumab + relatlimab fixed-dose combination (FDC) SC and provide patient experience data by route of administration. This study will also generate safety data which will further characterize the safety profile of patients switching the route of administration from intravenous (IV) to SC.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must have either metastatic melanoma and have not had previous treatment for their cancer, or resected melanoma and have had the cancer removed fully with surgery no later than 12 weeks before the start of treatment and confirmed free of disease
• Must have a low level of disability and cancer that is considered advanced for metastatic melanoma and at risk for becoming advanced (intermediate) or advanced for resected melanoma

Exclusion criteria

• Must not have any brain cancer/disease treated with radiation, any cancer in the eyes or mucous membranes (cells that cover inside surface of parts of the body and keep it moist), any autoimmune disease, or any condition that is being treated with steroids for inflammation (corticosteroids) or medication to decrease the body's immune system response (immunosuppressive drugs)

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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100 participants in 2 patient groups

Cohort 1: Metastatic Melanoma

Experimental group

Treatment:

Drug: relatlimab+nivolumab+rHuPH20

Drug: relatlimab+nivolumab

Cohort 2: Resected Melanoma

Experimental group

Treatment:

Drug: nivolumab

Drug: nivolumab+rHuPH20