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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

Brief 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.

Detailed Summary: Time Perspective: this study does have a retrospective component involving a subset of patients.
Sponsor: Bristol-Myers Squibb

Current Primary Outcome:

  • Incidence and severity of adverse reactions in patients treated with Ipilimumab in the post-approval setting [ Time Frame: Every 12 months up to 5 years ]
  • Incidence rate with person-year-exposure and frequency estimate of adverse events/serious adverse events [ Time Frame: Every 12 months up to 5 years ]
  • Frequency at which immunosuppressive therapy was administered to patients to manage treatment-related adverse events associated with Ipilimumab [ Time Frame: Every 12 months up to 5 years ]
  • Patterns of disease monitoring as observed in a real-world setting [ Time Frame: Every 12 months up to 5 years ]
    To evaluate patterns of care, descriptive statistics will describe treatment, dosing, regimen, indication, treatment rationales, management of treatment-related adverse events, reasons for treatment termination


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Quality of life (QoL), impact on work productivity, and overall satisfaction among patients receiving any therapy for unresectable or metastatic melanoma [ Time Frame: Every 12 months up to 5 years ]
  • Resource utilization associated with advanced melanoma treatment [ Time Frame: Every 12 months up to 5 years ]
    Descriptive statistics will be reported for healthcare utilization (inpatient, outpatient, emergency department and other ancillary services) and imputed costs
  • Overall survival (OS) in patients receiving Ipilimumab or other therapies for unresectable or metastatic melanoma [ Time Frame: Every 12 months up to 5 years ]


Original Secondary Outcome: Same as current

Information By: Bristol-Myers Squibb

Dates:
Date Received: November 15, 2011
Date Started: April 30, 2012
Date Completion: March 30, 2020
Last Updated: May 4, 2017
Last Verified: May 2017