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

Study Overview
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Brief Summary
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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
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Time Perspective: this study does have a retrospective component involving a subset of patients

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

Conditions
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Advanced Cutaneous Melanoma

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ipilimumab treatment cohort of 1106 prospective participants<br> | |
| Non-Ipilimumab treatment cohort of 305 prospective participants<br> | |
| Retrospective cohort of 177 participants<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse reactions in patients treated with Ipilimumab in the post-approval setting |  | Every 12 months up to 5 years | 
| Incidence rate with person-year-exposure and frequency estimate of adverse events/serious adverse events |  | 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 |  | Every 12 months up to 5 years | 
| Patterns of disease monitoring as observed in a real-world setting | 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 | Every 12 months up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Descriptive statistics will be reported for healthcare utilization (inpatient, outpatient, emergency department and other ancillary services) and imputed costs | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unresectable or metastatic cutaneous melanoma