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



Status:Completed
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:16 - Any
Updated:2/1/2019
Start Date:October 31, 2013
End Date:April 30, 2016

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Trial Summary
Trial Overview
Inclusion Criteria

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

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)

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
We found this trial at
3
sites
Local Institution
Linz,
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from
Linz,
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Outcome Sciences Inc Dba Outcome
Boston, Massachusetts 02284
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from
Boston, MA
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Local Institution
Boston, Massachusetts 02111
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mi
from
Boston, MA
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