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

18 Years
Open (Enrolling)
Cutaneous Melanoma

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Trial Information

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

Time Perspective: this study does have a retrospective component involving a subset of

Inclusion Criteria:

- Diagnosis of unresectable or metastatic melanoma

- Age of 18 years or older at time of diagnosis

- Received at least one prior therapy for unresectable or metastatic melanoma

- Receiving treatment for unresectable or metastatic melanoma at medical practice (e.g.
community-based, office-based, hospital-based, academic setting). Treatment decision
must already have been made by the physician prior to patient's entry in the study

- Ipilimumab-treated patients must be receiving treatment for the indication(s)
approved in their country of residence or where they are receiving treatment

Exclusion Criteria:

- Current or pending participation in a clinical trial examining therapy for the
treatment of any cancer (including unresectable or metastatic melanoma)

- Current use of therapy to treat a primary cancer other than melanoma

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Incidence and severity of adverse reactions in patients treated with Ipilimumab in the post-approval setting

Outcome Time Frame:

Every 12 months up to 5 years

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


European Union: European Medicines Agency

Study ID:




Start Date:

April 2012

Completion Date:

January 2017

Related Keywords:

  • Cutaneous Melanoma
  • Unresectable or metastatic cutaneous melanoma
  • Melanoma
  • Skin Neoplasms



Local InstitutionCincinnati, Ohio  
Local InstitutionPortland, Oregon  
Local InstitutionPhoenix, Arizona  
Local InstitutionCorona, California  
Local InstitutionLincoln, Nebraska  
Local InstitutionRome, Georgia  
Local InstitutionJackson, Mississippi  
Gabrail Cancer Center ResearchCanton, Ohio  44718