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

January 28, 2019 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

1773

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria, 4010
        • Local Institution
  • Belgium
      • Brussel, Belgium, 1090
        • Local Institution
  • Czechia
      • Praha 10, Czechia, 100 34
        • Local Institution
  • Denmark
      • Odense C, Denmark, 5000
        • Local Institution
  • France
      • Rouen, France, 76000
        • Local Institution
  • Germany
      • Buxtehude, Germany, 21614
        • Elbe Klinikum Buxtehude
  • Hungary
      • Debrecen, Hungary, 4032
        • Local Institution
  • Ireland
      • Dublin, Ireland, 9
        • Local Institution
  • Italy
      • Napoli, Italy, 80131
        • Local Institution
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Local Institution
  • Norway
      • Oslo, Norway, 0310
        • Local Institution
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • Local Institution
  • Spain
      • Valencia, Spain, 46009
        • Local Institution
  • Switzerland
      • Zurich, Switzerland, 8091
        • Local Institution
  • United Kingdom
    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7XX
        • Local Institution
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02284-5640
        • Local Institution
      • Boston, Massachusetts, United States, 02284
        • Outcome Sciences Inc Dba Outcome

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients participating in Expanded Access Program

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Population with condition and without condition
Participating in EAP

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Upto 60 month study period
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
Upto 60 month study period
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
Upto 60 month study period
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
Upto 60 month study period
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
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
Time Frame: Upto 60 month study period
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
Time Frame: Upto 60 month study period
Upto 60 month study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2013

Primary Completion (Actual)

April 30, 2016

Study Completion (Actual)

April 30, 2016

Study Registration Dates

First Submitted

June 3, 2015

First Submitted That Met QC Criteria

July 6, 2015

First Posted (Estimate)

July 9, 2015

Study Record Updates

Last Update Posted (Actual)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 28, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA184-367

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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