A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Advanced Cutaneous Melanoma
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 1411
- Locations
- 4
- Primary Endpoint
- Frequency at which immunosuppressive therapy was administered to patients to manage treatment-related adverse events associated with Ipilimumab
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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 Description
Time Perspective: this study does have a retrospective component involving a subset of patients
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
- Quality of life (QoL), impact on work productivity, and overall satisfaction among patients receiving any therapy for unresectable or metastatic melanoma(Every 12 months up to 5 years)
- Resource utilization associated with advanced melanoma treatment(Every 12 months up to 5 years)
- Overall survival (OS) in patients receiving Ipilimumab or other therapies for unresectable or metastatic melanoma(Every 12 months up to 5 years)