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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 Institution Cincinnati, Ohio  
Local Institution Portland, Oregon  
Local Institution Phoenix, Arizona  
Local Institution Corona, California  
Local Institution Lincoln, Nebraska  
Local Institution Rome, Georgia  
Local Institution Jackson, Mississippi  
Gabrail Cancer Center Research Canton, Ohio  44718