Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06101134
Start Date
November 6 2023
End Date
August 31 2027
Last Update
April 14 2025
Active Locations (31)
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1
Local Institution - 0007
Anchorage, Alaska, United States, 99508-2974
2
Local Institution - 0013
Phoenix, Arizona, United States, 85054-4502
3
Local Institution - 0010
San Francisco, California, United States, 94115-3010
4
Local Institution - 0034
Atlanta, Georgia, United States, 30342