The purpose of this study is to determine whether nivolumab is better than ipilimumab to prevent recurrence of melanoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
906
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Recurrence-free Survival (RFS)
RFS is defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma, or death (whatever the cause), whichever occurs first.
Time frame: up to 36 months
Overall Survival (OS)
OS is defined as as the time between the date of randomization and the date of death.
Time frame: up to 106.6 months
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Adverse Events
the safety and tolerability of Nivolumab and Ipilimumab was measured by the incidence of adverse events
Time frame: reported between first dose and 30 days after last dose of study therapy
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Serious Adverse Events
The Safety and Tolerability of nivolumab and ipilimumab was measured by the incidence of serious adverse events
Time frame: reported between the first dose and 30 days after last dose of study therapy
the Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Deaths
the safety and tolerability of Nivolumab and Ipilimumab was measured by the incidence of Deaths
Time frame: reported between first dose and 30 to 100 days after last dose of study therapy
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
The Safety and Tolerability of Nivolumab and Ipilimumab measured by the incidence of Laboratory abnormalities.
Time frame: reported after first dose and within 30 days of last dose of the study therapy
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Specified dose on specified days
Local Institution - 0036
Little Rock, Arkansas, United States
Local Institution - 0117
La Jolla, California, United States
Local Institution - 0189
Los Angeles, California, United States
Local Institution - 0021
San Francisco, California, United States
Local Institution - 0006
San Francisco, California, United States
Local Institution - 0010
Aurora, Colorado, United States
Local Institution - 0004
Washington D.C., District of Columbia, United States
Local Institution - 0012
Jacksonville, Florida, United States
Local Institution - 0019
Miami Beach, Florida, United States
Local Institution - 0030
Orlando, Florida, United States
...and 126 more locations
Recurrence-free Survival by PD-L1 Expression
Recurrence-free survival by PD-L1 Expression(5% tumor cell membrane expression)
Time frame: up to 106.6 months
Health Related Quality of Life (HRQoL) Evaluation
HRQoL was measured by mean changes from baseline in EORTC-QLQ-C30 global health status/QoL composite scale and in remaining EORTC QLQ-C30 scales in all randomized participants. EORTC QLQ-C30 is the most commonly used QoL instrument in melanoma clinical studies, is a 30-item instrument that has gained wide acceptance in oncology clinical studies and comprises 5 functional scales (physical functioning, cognitive functioning, emotional functioning, social functioning and global quality of life) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Except for the overall health status and global quality of life items, responses for all items are 4 point categorical scales ranging from 1 (Not at all) to 4 (Very much). The overall health status/quality of life responses are 7-point Likert scales for which higher score reflects higher health status/quality of life for the 7-point Likert scale.
Time frame: up to 36 months