Melanoma Clinical Trial
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
| NCT number | NCT02492815 |
| Other study ID # | CA184-367 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 31, 2013 |
| Est. completion date | April 30, 2016 |
| Verified date | January 2019 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 1773 |
| Est. completion date | April 30, 2016 |
| Est. primary completion date | April 30, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 16 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Local Institution | Linz | |
| Belgium | Local Institution | Brussel | |
| Czechia | Local Institution | Praha 10 | |
| Denmark | Local Institution | Odense C | |
| France | Local Institution | Rouen | |
| Germany | Elbe Klinikum Buxtehude | Buxtehude | |
| Hungary | Local Institution | Debrecen | |
| Ireland | Local Institution | Dublin | |
| Italy | Local Institution | Napoli | |
| Netherlands | Local Institution | Amsterdam | |
| Norway | Local Institution | Oslo | |
| Russian Federation | Local Institution | Moscow | |
| Spain | Local Institution | Valencia | |
| Switzerland | Local Institution | Zurich | |
| United Kingdom | Local Institution | Guildford | Surrey |
| United States | Local Institution | Boston | Massachusetts |
| United States | Outcome Sciences Inc Dba Outcome | Boston | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Austria, Belgium, Czechia, Denmark, France, Germany, Hungary, Ireland, Italy, Netherlands, Norway, Russian Federation, Spain, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall survival (OS) of patients enrolled in the European ipilimumab EAP | Upto 60 month study period | ||
| Secondary | Demographic characteristics (age, weight, gender, race) of patients enrolled in the European ipilimumab EAP collected from medical charts | Upto 60 month study period | ||
| Secondary | 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 | ||
| Secondary | Frequency of discontinuing or skipping ipilimumab administrations among patients enrolled in the European ipilimumab EAP collected from medical charts | Upto 60 month study period | ||
| Secondary | Reasons for discontinuing or skipping ipilimumab administrations among patients enrolled in the European ipilimumab EAP collected from medical charts | Upto 60 month study period | ||
| Secondary | Treatment outcomes in specific sub-populations of patients enrolled in the European ipilimumab EAP collected from medical charts | Upto 60 month study period | ||
| Secondary | 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 | ||
| Secondary | 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 |
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