PAN-EU Utilization, Effectiveness and Safety of Ipilimumab Administered in EAP Patients With Advanced Melanoma

Study Overview
=================
Brief Summary
-----------------
Observational study to evaluate the effectiveness and safety of ipilimumab, administered during the European expanded access programme (EAP) in pretreated patients with advanced (unresectable or metastatic) melanoma.

Detailed Description
-----------------
Minimum age: 18 years old (at time of inclusion in the CA184-367- but 16 for the EAP)

Official Title
-----------------
An Observational Study to Evaluate the Effectiveness and Safety of Ipilimumab, Administered During the European Expanded Access Programme in Pretreated Patients With Advanced (Unresectable or Metastatic) Melanoma

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients have been enrolled in the EAPs Patients still alive must provide informed consent if required by local regulations Deceased patients are eligible per local regulations, their legal representatives must provide informed consent if required by local regulations Exclusion Criteria: There are no specific exclusion criteria in this observational study other than the exclusion criteria of the EAP

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Population with condition and without condition<br>Participating in EAP | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) of patients enrolled in the European ipilimumab EAP |  | Upto 60 month study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic characteristics (age, weight, gender, race) of patients enrolled in the European ipilimumab EAP collected from medical charts |  | Upto 60 month study period | 
| Clinical characteristics (biological values, stage of initial diagnosis, primary location of melanoma) of patients enrolled in the European ipilimumab EAP collected from medical charts |  | Upto 60 month study period | 
| Frequency of discontinuing or skipping ipilimumab administrations among patients enrolled in the European ipilimumab EAP collected from medical charts |  | Upto 60 month study period | 
| Reasons for discontinuing or skipping ipilimumab administrations among patients enrolled in the European ipilimumab EAP collected from medical charts |  | Upto 60 month study period | 
| Treatment outcomes in specific sub-populations of patients enrolled in the European ipilimumab EAP collected from medical charts |  | Upto 60 month study period | 
| Influence of demographic characteristics (age, weight, gender, race) on effectiveness and safety outcomes among patients enrolled in the European ipilimumab EAP collected from medical charts |  | Upto 60 month study period | 
| Influence of clinical characteristics (biological values, stage of initial diagnosis, primary location of melanoma) on effectiveness and safety outcomes among patients enrolled in the European ipilimumab EAP collected from medical charts |  | Upto 60 month study period |