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

Running, not enrolling · Phase 2

Conditions studied: Melanoma

In brief

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.

Key facts

Study ID

NCT06101134

Run by

Bristol-Myers Squibb

People needed

100

Starts

2023-11-06

Expected to finish

2027-08-31

Last updated by the study team

2026-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Local Institution - 0006 — Seville, Spain
• Local Institution - 0007 — Anchorage, Alaska, United States
• Local Institution - 0013 — Phoenix, Arizona, United States
• Local Institution - 0010 — San Francisco, California, United States
• Local Institution - 0034 — Atlanta, Georgia, United States
• Local Institution - 0032 — Edgewood, Kentucky, United States
• Local Institution - 0028 — Albuquerque, New Mexico, United States
• Local Institution - 0037 — Edmonds, Washington, United States
• Local Institution - 0036 — Issaquah, Washington, United States
• Local Institution - 0030 — Seattle, Washington, United States
• Local Institution - 0015 — Las Condes, Santiago Metropolitan, Chile
• Local Institution - 0005 — Concepción, Chile
• Local Institution - 0019 — Thessaloniki, B, Greece
• Local Institution - 0014 — Athens, I, Greece
• Local Institution - 0029 — Marousi, I, Greece
• Local Institution - 0023 — Holargos, Athens, Greece
• Local Institution - 0008 — Piraeus, Greece
• Local Institution - 0033 — Thessaloniki, Greece
• Local Institution - 0017 — Bergamo, BG, Italy
• Local Institution - 0035 — Meldola, FC, Italy
• Local Institution - 0018 — Milan, MI, Italy
• Local Institution - 0012 — Padova, PD, Italy
• Local Institution - 0021 — Roma, RM, Italy
• Local Institution - 0004 — Torino, TO, Italy
• Local Institution - 0026 — Naples, Italy

Full record on ClinicalTrials.gov

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