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Clinical Trial VICCMEL12117


A Multi-Site Retrospective Observational Study of US Patients with Unresectable or Metastatic Melanoma Receiving Ipilimumab (YERVOY?) as First-Line Therapy

Principal Investigator(s)

Douglas Johnson


  • Protocol No. VICCMEL12117
  • Open Date: 02/18/2013
  • Staging: N/A
  • Age Group: Adults
  • Scope: International
  • Objective: - To describe the demographic and clinical characteristics of real-world adult patients receiving ipilimumab for first-line treatment of advanced melanoma (unresectable or metastatic melanoma). - To describe the occurrence and severity of all adverse events (AEs) and treatment-related AE's in adult patients receiving first-line ipilimumab in a real-world setting as well as those observed during any subsequent lines of treatment in the year following initiation of treatment with ipilimumab. In the remaining 3 years of the study follow-up, the description of the occurrence and severity of AE's will be limited to those that are related to treatment. - To describe patterns of care during first-line advanced melanoma treatment with ipilimumab (dosing, number and dates of doses, treatment rationales, reasons for treatment rationales, reasons for treatment termination, etc) as well as any subsequent lines of therapy. - To describe the overall survival (OS) (mean, median, and 1-,2-, 3- and 4-year OS) of patients receiving ipilimumab as first-line treatment.
  • Disease Sites: Melanoma
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Ipilimumab
  • Participating Institutions: Vanderbilt University
  • Secondary Protocol No: CA184338


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