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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02492815

Enrollment

1773

Registered

2015-07-09

Start date

2013-10-31

Completion date

2016-04-30

Last updated

2019-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

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)

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
Demographic characteristics (age, weight, gender, race) 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
Treatment outcomes in specific sub-populations of patients enrolled in the European ipilimumab EAP collected from medical charts	Upto 60 month study period

Countries

Austria, Belgium, Czechia, Denmark, France, Germany, Hungary, Ireland, Italy, Netherlands, Norway, Russia, Spain, Switzerland, United Kingdom, United States

Outcome results