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

Completed

• Conditions: Advanced Cutaneous Melanoma

• Registration Number: NCT01511913
• Lead Sponsor: Bristol-Myers Squibb

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

Study Timeline

• Study First Submitted: 2011-11-15
• Study First Submitted QC: 2012-01-18
• Study First Posted: 2012-01-19
• Study Start: 2012-06-03
• Primary Completion: 2018-03-30
• Study Completion: 2019-12-12
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-22
• Last Update Posted: 2021-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1411

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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	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

Trial Locations

Locations (4)

Mid Ohio Onc/Hem, Inc; 🇺🇸 Columbus, Ohio, United States

Local Institutio; 🇬🇷 Alexandroupolis, Greece

Local institution; 🇬🇷 Goudi, Athens, Greece

Local Institution; 🇬🇧 Yeovil, Somerset, United Kingdom