Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma

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.

OS is defined as as the time between the date of randomization and the date of death.

the safety and tolerability of Nivolumab and Ipilimumab was measured by the incidence of adverse events

The Safety and Tolerability of nivolumab and ipilimumab was measured by the incidence of serious adverse events

the safety and tolerability of Nivolumab and Ipilimumab was measured by the incidence of Deaths

The Safety and Tolerability of Nivolumab and Ipilimumab measured by the incidence of Laboratory abnormalities.

Recurrence-free survival by PD-L1 Expression(5% tumor cell membrane expression)

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.