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

Bristol-Myers Squibb3 sites in 3 countries1,773 target enrollmentOctober 31, 2013

ConditionsMelanoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Melanoma
Sponsor: Bristol-Myers Squibb
Enrollment: 1773
Locations: 3
Primary Endpoint: Overall survival (OS) of patients enrolled in the European ipilimumab EAP
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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)

Registry

clinicaltrials.gov

Start Date

October 31, 2013

End Date

April 30, 2016

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Overall survival (OS) of patients enrolled in the European ipilimumab EAP

Time Frame: Upto 60 month study period

Secondary Outcomes

Reasons for discontinuing or skipping ipilimumab administrations among patients enrolled in the European ipilimumab EAP collected from medical charts(Upto 60 month study period)
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)
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)