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

Completed

• Conditions: Melanoma

• Registration Number: NCT02492815
• Lead Sponsor: Bristol-Myers Squibb

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)

Study Timeline

• Study Start: 2013-10-31
• Study First Submitted: 2015-06-03
• Study First Submitted QC: 2015-07-06
• Study First Posted: 2015-07-09
• Primary Completion: 2016-04-30
• Study Completion: 2016-04-30
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-28
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1773

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

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Exclusion Criteria

• There are no specific exclusion criteria in this observational study other than the exclusion criteria of the EAP

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival (OS) of patients enrolled in the European ipilimumab EAP	Upto 60 month study period

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Local Institution; 🇬🇧 Guildford, Surrey, United Kingdom

Outcome Sciences Inc Dba Outcome; 🇺🇸 Boston, Massachusetts, United States

Elbe Klinikum Buxtehude; 🇩🇪 Buxtehude, Germany