A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations
- Conditions
- Melanoma
- Interventions
- Registration Number
- NCT06101134
- Lead Sponsor
- Bristol-Myers Squibb
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2: Resected Melanoma nivolumab - Cohort 1: Metastatic Melanoma relatlimab+nivolumab - Cohort 2: Resected Melanoma nivolumab+rHuPH20 - Cohort 1: Metastatic Melanoma relatlimab+nivolumab+rHuPH20 -
- Primary Outcome Measures
Name Time Method Number of participants that prefer subcutaneous (SC) route of administration as assessed by Question 7 of the Patient Experience and Preference Questionnaire (PEPQ) At Cycle 4 Day 1 (each cycle is 28 days)
- Secondary Outcome Measures
Name Time Method Number of participants with Adverse Events (AEs) Up to approximately 2.5 years Number of participants with Immune-mediated AEs (IMAEs) Up to approximately 2.5 years Number of deaths Up to approximately 2.5 years Number of participants with AEs leading to discontinuation Up to approximately 2.5 years Number of participants with injection/infusion-related AEs Up to approximately 2.5 years Number of participants with Serious AEs (SAEs) Up to approximately 2.5 years Number of participants with other events of special interest (OESIs) Up to approximately 2.5 years Number of participants with laboratory abnormalities Up to approximately 2.5 years Number of participants with treatment-related AEs Up to approximately 2.5 years
Trial Locations
- Locations (31)
Local Institution - 0036
🇺🇸Issaquah, Washington, United States
Local Institution - 0030
🇺🇸Seattle, Washington, United States
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
🇬🇷Peiraias, 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
🇮🇹Napoli, Italy
Local Institution - 0011
🇪🇸Barcelona, B, Spain
Local Institution - 0022
🇪🇸Barcelona, B, Spain
Local Institution - 0009
🇪🇸Cartagena, MU, Spain
Local Institution - 0020
🇪🇸Badalona, Spain
Local Institution - 0027
🇪🇸Cantabria, Spain
Local Institution - 0003
🇪🇸San Pedro Alcántara, Málaga, Spain
Local Institution - 0006
🇪🇸Sevilla, Spain
Local Institution - 0007
🇺🇸Anchorage, Alaska, 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 - 0015
🇨🇱Las Condes, Santiago, Chile
Local Institution - 0005
🇨🇱Concepcion, Chile
Local Institution - 0013
🇺🇸Phoenix, Arizona, United States
Local Institution - 0037
🇺🇸Edmonds, Washington, United States