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NCT Number: NCT02492815

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

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution, Linz, Austria

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About this study

Minimum age: 18 years old (at time of inclusion in the CA184-367- but 16 for the EAP)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Overall survival (OS) of patients enrolled in the European ipilimumab EAP

    Time frame: Upto 60 month study period

Secondary outcomes

  1. Demographic characteristics (age, weight, gender, race) of patients enrolled in the European ipilimumab EAP collected from medical charts

    Time frame: Upto 60 month study period

  2. Clinical characteristics (biological values, stage of initial diagnosis, primary location of melanoma) of patients enrolled in the European ipilimumab EAP collected from medical charts

    Time frame: Upto 60 month study period

  3. Frequency of discontinuing or skipping ipilimumab administrations among patients enrolled in the European ipilimumab EAP collected from medical charts

    Time frame: Upto 60 month study period

  4. Reasons for discontinuing or skipping ipilimumab administrations among patients enrolled in the European ipilimumab EAP collected from medical charts

    Time frame: Upto 60 month study period

  5. Treatment outcomes in specific sub-populations of patients enrolled in the European ipilimumab EAP collected from medical charts

    Time frame: Upto 60 month study period

  6. 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

    Time frame: Upto 60 month study period

  7. 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

    Time frame: Upto 60 month study period

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 9, 2015
Registry last updated
Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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