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

• Register: ClinicalTrials.gov
• Last refreshed on: 4 January 2022
• Main ID: NCT01511913
• Date of registration: 15/11/2011
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma IMAGE
• Scientific title: A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma
• Date of first enrolment: June 3, 2012
• Target sample size: 1411
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01511913
• Study type: Observational

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Canada, France, Germany, Greece, Ireland, Israel, Mexico, Poland, Spain, Switzerland, United Kingdom, United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com.

Inclusion Criteria:

- Diagnosis of unresectable or metastatic melanoma

- Age of 18 years or older at time of entry into the study

- Patients who have initiated treatment for unresectable or metastatic melanoma at
medical practice (e.g. community-based, office-based, hospital-based, academic
setting)within 21 days before informed consent for this study OR in the case where
treatment has not yet been initiated, documentation that the treatment strategy was
determined before informed consent for this study, and treatment must be initiated
within 28 days after informed consent

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Advanced Cutaneous Melanoma

Primary Outcome(s)

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]

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]

Incidence rate with person-year-exposure and frequency estimate of adverse events/serious adverse events [Time Frame: Every 12 months up to 5 years]

Secondary Outcome(s)

Overall survival (OS) in patients receiving Ipilimumab or other therapies for unresectable or metastatic melanoma [Time Frame: Every 12 months up to 5 years]

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]

Secondary ID(s)

CA184-143

ENCEPP/SDPP/2723

Source(s) of Monetary Support

Please refer to primary and secondary sponsors