A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations
Sponsor: Bristol-Myers Squibb
ClinicalTrials ID:NCT06101134
This study evaluates patient preference and safety for switching from IV to SC administration of nivolumab and nivolumab + relatlimab FDC in melanoma patients. Eligible participants include those with metastatic or resected melanoma, excluding those with brain cancer, eye/mucous membrane cancer, autoimmune diseases, or on immunosuppressive treatments. Interventions involve specified doses of the drug combinations.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
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.
Eligibility Criteria
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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Alaska Oncology & Hematology, LLC | 99508-2974 | Anchorage | Alaska |
| Mayo Clinic Hospital - Phoenix | 85054-4502 | Phoenix | Arizona |
| University of California, San Francisco, Medical Center at Mount Zion | 94115-3010 | San Francisco | California |
| Northside Hospital - Atlanta | 30342 | Atlanta | Georgia |
| Saint Elizabeth Healthcare | 41017 | Edgewood | Kentucky |
| University of New Mexico Cancer Center | 87106 | Albuquerque | New Mexico |
| Icahn School of Medicine at Mount Sinai (ISMMS) - The Derald H. Ruttenberg Treatment Center | 10029-6542 | New York | New York |
| Local Institution - 0037 | 98026-8032 | Edmonds | Washington |
| Local Institution - 0036 | 98026 | Issaquah | Washington |
| Swedish Cancer Institute | 98104 | Seattle | Washington |
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