The goal of this study is to describe patient characteristics, treatment outcomes and adverse events for patients with metastatic melanoma testing positive for PD-L1 expression treated first line (1L) with either nivolumab and ipilimumab in combination (NIVO + IPI) or nivolumab (NIVO) monotherapy
Study Type
OBSERVATIONAL
Enrollment
600
Non-Interventional
Local Institution
Parsippany, New Jersey, United States
Overall Survival (OS) from Advanced Diagnosis
Time frame: Minimum follow up 1 year
Progression Free Survival (PFS) from Advanced Diagnosis
Time frame: Minimum follow up 1 year
Overall Survival (OS) from 1L Therapy Initiation
Time frame: Minimum follow up 1 year
Progression Free Survival (PFS) from Index Date
Time frame: Minimum follow up 1 year
Objective Response Rate (ORR)
Time frame: Minimum follow up 1 year
Best Therapy Response
Best response (complete response, CR or partial response, PR) will be measured from the start of index treatment to progression or recurrence. Outcome will be reported as the percent of patients achieving best response from the total population of patients in a study arm.
Time frame: Minimum follow up 1 year
Time to Best Therapy Response
Time frame: Minimum follow up 1 year
Time to Loss of Peak Response
Time frame: Minimum follow up 1 year
Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Minimum follow up 1 year
Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) criteria
Time frame: Minimum follow up 1 year
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Incidence of AE's
Time frame: Minimum follow up 1 year
Incidence of SAE's
Time frame: Minimum follow up 1 year