Advanced Cutaneous Melanoma
Conditions
Keywords
Unresectable or metastatic cutaneous melanoma
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
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resource utilization associated with advanced melanoma treatment | Every 12 months up to 5 years | Descriptive statistics will be reported for healthcare utilization (inpatient, outpatient, emergency department and other ancillary services) and imputed costs |
| Overall survival (OS) in patients receiving Ipilimumab or other therapies for unresectable or metastatic melanoma | 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 | Every 12 months up to 5 years | — |
Countries
Argentina, Australia, Austria, Belgium, Canada, France, Germany, Greece, Ireland, Israel, Poland, Spain, Switzerland, United Kingdom, United States
Outcome results
None listed