A Comparison of Nivolumab-based Treatments in a Real-world PD-L1 Positive Metastatic Melanoma Population in the US

Study Overview
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Brief Summary
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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

Official Title
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A Retrospective Observational Study Comparing Nivolumab + Ipilimumab Combination vs. Nivolumab Monotherapy as First Line Treatment of Metastatic PD-L1 Positive Melanoma in the US

Conditions
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Melanoma

Intervention / Treatment
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* Other: Non-Interventional


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 18 years or older First advanced of diagnosis of metastatic/Stage IV) melanoma Tested for PD-L1 expression with a tumor proportion score (TPS) greater than or equal to 1% (Phase 1 data collection) Initiating a first line of therapy during the index period between October 1, 2015 through July 1, 2017 Medical history available for medical chart abstraction from date of diagnosis through most recent or current therapy (defined as end of data collection period) Exclusion Criteria: Patients enrolled in a cancer treatment-related clinical trial prior to first line therapy initiation for metastatic/Stage IV) melanoma Other protocol defined inclusion/exclusion criteria could apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing treatment with nivolumab and ipilimumab<br> | Other: Non-Interventional<br>* Non-Interventional<br>|
| Patients undergoing treatment with nivolumab<br> | Other: Non-Interventional<br>* Non-Interventional<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) from Advanced Diagnosis |  | Minimum follow up 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) from Advanced Diagnosis |  | Minimum follow up 1 year | 
| Overall Survival (OS) from 1L Therapy Initiation |  | Minimum follow up 1 year | 
| Progression Free Survival (PFS) from Index Date |  | Minimum follow up 1 year | 
| Objective Response Rate (ORR) |  | 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. | Minimum follow up 1 year | 
| Time to Best Therapy Response |  | Minimum follow up 1 year | 
| Time to Loss of Peak Response |  | Minimum follow up 1 year | 
| Response Evaluation Criteria in Solid Tumors (RECIST) |  | Minimum follow up 1 year | 
| Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) criteria |  | Minimum follow up 1 year | 
| Incidence of AE's |  | Minimum follow up 1 year | 
| Incidence of SAE's |  | Minimum follow up 1 year |