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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
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.
Official title: A Phase 2 Open-label, Two-cohort Study to Evaluate Patient Preference for Nivolumab + Relatlimab Fixed-dose Combination Subcutaneous Versus Nivolumab + Relatlimab Fixed-dose Combination Intravenous and Nivolumab Subcutaneous Versus Nivolumab Intravenous in Participants With Melanoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2023-11-06
Completion Date
2027-08-31
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
relatlimab+nivolumab
Specified dose on specified days
relatlimab+nivolumab+rHuPH20
Specified dose on specified days
nivolumab
Specified dose on specified days
nivolumab+rHuPH20
Specified dose on specified days
Locations (31)
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
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
Seville, Spain