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
Percentage of Evaluable Participants That Prefer SC Route of Administration Using the Patient Experience and Preference Questionnaire (PEPQ) (Question 7) After Cycle 4 Day 1 Dose
PEPQ included 7 items 1. Pain or Discomfort (rated on 1 to 10 scale), 2. Length of time related to administration 3. Length of time related to administration impact amount of time to speak to doctor or nurse about illness or concern 4. Length of time for administration impact time to interact or socialize with other individuals 5. Convenience 6. Satisfaction 7. Choice of which route of administration would be preferred. 95% CI exact confidence interval was reported.
Time frame: Cycle 4 Day 1 (each cycle consist of 4 weeks)
Number of Participants With Adverse Events and Deaths
An adverse event is any untoward medical occurrence that begins or worsens after the first dose of study treatment, including any unfavorable sign, symptom, disease, or abnormal lab finding, whether or not related to the product, and may include worsening of pre-existing conditions. A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, causes persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect, or is considered an important medical event requiring intervention to prevent these outcomes.
Time frame: First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 16 months)
Number of Participants With Laboratory Abnormalities and Immune Mediate Adverse Event
Time frame: From first dose (Day 1) and up to study completion (up to approximately 45 months)
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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