Clinical trial · Observational
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
NCT02492815CI-TRIAL-00036808completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Population with condition and without condition
- description
- Participating in EAP
Primary outcomes (1)
- measure
- Overall survival (OS) of patients enrolled in the European ipilimumab EAP
- timeFrame
- Upto 60 month study period
Secondary outcomes (7)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.