Clinical trial NCT02492815: PAN-EU Utilization, Effectiveness and Safety of Ipilimumab Administered in EAP Patients With Advanced Melanoma
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-07-09
Enrollment: 1773
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients participating in Expanded Access Program

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)

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

Primary outcomes:
measure: Overall survival (OS) of patients enrolled in the European ipilimumab EAP
timeFrame: Upto 60 month study period
Secondary outcomes:
measure: Demographic characteristics (age, weight, gender, race) of patients enrolled in the European ipilimumab EAP collected from medical charts
timeFrame: Upto 60 month study period
measure: Clinical characteristics (biological values, stage of initial diagnosis, primary location of melanoma) of patients enrolled in the European ipilimumab EAP collected from medical charts
timeFrame: Upto 60 month study period
measure: Frequency of discontinuing or skipping ipilimumab administrations among patients enrolled in the European ipilimumab EAP collected from medical charts
timeFrame: Upto 60 month study period
measure: Reasons for discontinuing or skipping ipilimumab administrations among patients enrolled in the European ipilimumab EAP collected from medical charts
timeFrame: Upto 60 month study period
measure: Treatment outcomes in specific sub-populations of patients enrolled in the European ipilimumab EAP collected from medical charts
timeFrame: Upto 60 month study period
measure: 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
timeFrame: Upto 60 month study period
measure: 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
timeFrame: Upto 60 month study period
Other outcomes:
Locations:
city: Boston
country: United States
facility: Local Institution
state: Massachusetts
city: Boston
country: United States
facility: Outcome Sciences Inc Dba Outcome
state: Massachusetts
city: Linz
country: Austria
facility: Local Institution
city: Brussel
country: Belgium
facility: Local Institution
city: Praha 10
country: Czechia
facility: Local Institution
city: Odense C
country: Denmark
facility: Local Institution
city: Rouen
country: France
facility: Local Institution
city: Buxtehude
country: Germany
facility: Elbe Klinikum Buxtehude
city: Debrecen
country: Hungary
facility: Local Institution
city: Dublin
country: Ireland
facility: Local Institution
city: Napoli
country: Italy
facility: Local Institution
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Oslo
country: Norway
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
city: Zurich
country: Switzerland
facility: Local Institution
city: Guildford
country: United Kingdom
facility: Local Institution
state: Surrey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: