Active — Not RecruitingPhase 2

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

United States100 participantsStarted 2023-11-06

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Percentage of Evaluable Participants That Prefer SC Route of Administration Using the Patient Experience and Preference Questionnaire (PEPQ) (Question 7) After Cycle 4 Day 1 Dose

Timeframe: Cycle 4 Day 1 (each cycle consist of 4 weeks)

Trial details

NCT IDNCT06101134

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-10

Results submitted2026-03-11