Status:

COMPLETED

Long Term Quality of Life in Melanoma Patients in Netherlands

Lead Sponsor:

Bristol-Myers Squibb

Conditions:

Melanoma

Eligibility:

All Genders

18+ years

Brief Summary

Study of late physical, psychological and social effects in patients treated with ipilimumab for advanced (stage IV or unresectable stage III) melanoma.

Eligibility Criteria

Inclusion

  • Inclusion Criteria-
  • Patient population: Adults ≥ 18 years of age at diagnosis, diagnosed with histologically confirmed advanced (stage IV or unresectable stage III) melanoma, who have received at least one course of ipilimumab treatment (first, second, or second plus line; routine practice or study treatment) in one of the specified treatment centers, and who have survived at least 2 years after (completion of) ipilimumab treatment (measured from last ipilimumab administration)
  • Matched healthy control population: Individuals without melanoma (stage III or IV) diagnosis that have been included in the PROFILES cohort
  • Exclusion Criteria
  • Insufficient understanding of the Dutch language
  • Other anticancer treatment after ipilimumab or during study entry
  • Disease recurrence during the study
  • Other protocol defined inclusion/exclusion criteria could apply

Exclusion

    Key Trial Info

    Start Date :

    December 15 2016

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    June 17 2020

    Estimated Enrollment :

    89 Patients enrolled

    Trial Details

    Trial ID

    NCT03450876

    Start Date

    December 15 2016

    End Date

    June 17 2020

    Last Update

    September 11 2020

    Active Locations (1)

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    Local Institution

    Amsterdam, Netherlands, 1066 CX