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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Number of participants that prefer subcutaneous (SC) route of administration as assessed by Question 7 of the Patient Experience and Preference Questionnaire (PEPQ)
Time frame: At Cycle 4 Day 1 (each cycle is 28 days)
Number of participants with Adverse Events (AEs)
Time frame: Up to approximately 2.5 years
Number of participants with Serious AEs (SAEs)
Time frame: Up to approximately 2.5 years
Number of participants with treatment-related AEs
Time frame: Up to approximately 2.5 years
Number of participants with AEs leading to discontinuation
Time frame: Up to approximately 2.5 years
Number of participants with Immune-mediated AEs (IMAEs)
Time frame: Up to approximately 2.5 years
Number of participants with other events of special interest (OESIs)
Time frame: Up to approximately 2.5 years
Number of participants with injection/infusion-related AEs
Time frame: Up to approximately 2.5 years
Number of deaths
Time frame: Up to approximately 2.5 years
Number of participants with laboratory abnormalities
Time frame: Up to approximately 2.5 years
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Specified dose on specified days
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
...and 21 more locations