Effectiveness, Safety and Use of Nivolumab Administered During the French Temporary Authorization for Use in Patients With Advanced Melanoma

Study Overview
=================
Brief Summary
-----------------
This study will be conducted with the aim of estimating the effectiveness, safety, patterns of use of nivolumab, and characteristics of patients with unresectable or metastatic melanoma, treated with nivolumab monotherapy in the ATU setting.

Official Title
-----------------
Effectiveness, Safety and Use of Nivolumab Administered During the French Temporary Authorization for Use in Patients With Advanced (Unresectable or Metastatic) Melanoma: A Multicentric, Observational Study

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Other: Non-interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients included in RIC-Mel Database: Diagnosed with melanoma and cared for in the participating sites Patients who have been given appropriate information about RIC-Mel Database aims and who have provided their written consent for data collection and processing before any data collection is carried out Patients included in French nivolumab ATU program Exclusion Criteria: • Patients included in RIC-Mel database having initiated nivolumab before 12-Sep-2014 or after 31-Aug-2015, or in the context of a clinical trial Other protocol defined inclusion/exclusion criteria could apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Advanced Melanoma<br>RIC-Mel patients with advanced (unresectable or metastatic) melanoma treated with nivolumab in the context of nivolumab ATU program (occurred from 12-Sep-2014 to 31-Aug-2015) | Other: Non-interventional<br>* Non-interventional<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) at 1 year | Overall survival (OS) for adult patients with advanced (unresectable or metastatic) melanoma treated with nivolumab in the ATU (Temporary Authorization for Use) program | at 1 year | 
| Distribution of demographic characteristics of patients with advanced melanoma treated with nivolumab monotherapy in the ATU program | Distribution of demographic characteristics of patients with advanced melanoma treated with nivolumab monotherapy in the ATU program using descriptive statistics | at baseline | 
| Distribution of clinical characteristics in patients with advanced melanoma treated with nivolumab monotherapy | Clinical characteristics will be summarized using descriptive statistics. | at baseline | 
| Overall survival (OS) at 2 years | Overall survival (OS) for adult patients with advanced (unresectable or metastatic) melanoma treated with nivolumab in the ATU (Temporary Authorization for Use) program | at 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) | (PFS) will be measured by the time since nivolumab initiation to either the first disease progression date or last known tumor assessment date, or death | 1 year and 2 years | 
| Objective response rate (ORR) | ORR is the proportion of patients with an objective response. Objective response is measured by the sum of partial responses plus complete responses as assessed by (RECIST 1.1) Response Evaluation Criteria In Solid Tumors | 1 year and 2 years | 
| Progression-free survival (PFS) as assessed by RECIST 1.1 | PFS measured by time since index date (initial treatment with nivolumab) to either the first disease progression date or last known tumor assessment date, or death due to any cause, whichever occurs first as assessed by RECIST 1.1 | at 1 year | 
| Distribution of treatment patterns | Details on Prior and Evolution of Current Treatment Patterns will be summarized using descriptive statistics. | up to 2 years | 
| Incidence of select Grade 3, 4, or 5 adverse events (AEs) | Select AEs include pulmonary, endocrine, gastrointestinal, hepatic, renal, cutaneous, and infusion reactions | up to 2 years |