A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma

Official Title

A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma

Summary:

The purpose of this study is to examine the safety of Ipilimumab and patterns of use in the treatment of unresectable or metastatic melanoma in the post-approval setting.

Trial Description

Primary Outcome:

  • Incidence and severity of adverse reactions in patients treated with Ipilimumab in the post-approval setting
  • Incidence rate with person-year-exposure and frequency estimate of adverse events/serious adverse events
  • Frequency at which immunosuppressive therapy was administered to patients to manage treatment-related adverse events associated with Ipilimumab
  • Patterns of disease monitoring as observed in a real-world setting
Secondary Outcome:
  • Quality of life (QoL), impact on work productivity, and overall satisfaction among patients receiving any therapy for unresectable or metastatic melanoma
  • Resource utilization associated with advanced melanoma treatment
  • Overall survival (OS) in patients receiving Ipilimumab or other therapies for unresectable or metastatic melanoma
Time Perspective: this study does have a retrospective component involving a subset of patients.

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society