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

N/ACompletedNCT02492815

Bristol-Myers Squibb1,773 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

1,773

Conditions

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (17)

Local Institution

Boston, Massachusetts, United States

Outcome Sciences Inc Dba Outcome

Boston, Massachusetts, United States

Local Institution

Linz, Austria

Outcomes

Primary Outcomes

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

Time frame: Upto 60 month study period

Secondary Outcomes

Demographic characteristics (age, weight, gender, race) of patients enrolled in the European ipilimumab EAP collected from medical charts

Time frame: 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

Time frame: Upto 60 month study period

Frequency of discontinuing or skipping ipilimumab administrations among patients enrolled in the European ipilimumab EAP collected from medical charts

Time frame: Upto 60 month study period

Reasons for discontinuing or skipping ipilimumab administrations among patients enrolled in the European ipilimumab EAP collected from medical charts

Time frame: Upto 60 month study period

Treatment outcomes in specific sub-populations of patients enrolled in the European ipilimumab EAP collected from medical charts

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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NCT02492815 - PAN-EU Utilization, Effectiveness and Safety of Ipilimumab Administered in EAP Patients With Advanced Melanoma | Crick | Crick