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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Advanced Cutaneous Melanoma

Study type: Observational

Funder types: Industry

Identifiers

NCT01511913

ENCEPP/SDPP/2723 (Other Identifier)

CA184-143

Details and patient eligibility

About

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

Full description

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

Enrollment: 1,411 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

1,411 participants in 3 patient groups

Ipilimumab treatment cohort of 1106 prospective participants

Non-Ipilimumab treatment cohort of 305 prospective participants

Retrospective cohort of 177 participants