Study of First-line Treatment Patterns and Clinical Outcomes in Patients With Advanced Melanoma in the United Kingdom

NCT ID: NCT03448497

Last Updated: 2019-08-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 333 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-12-14
• Study Completion Date: 2018-04-27

Brief Summary

The purpose of this study is to describe the first-line therapy landscape for patients with advanced melanoma and to describe clinical outcomes and healthcare resource utilization in a subset of treatment-naïve patients who initiated nivolumab + ipilimumab combination therapy.

Conditions

Melanoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Advanced Melanoma patients who intiated first-line therapy

patients who initiated any first-line therapy for advanced melanoma and had not previously received treatment for their advanced disease

Non-interventional

Intervention Type: OTHER

Non-interventional

Interventions

Non-interventional

Non-interventional

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient has medical chart documentation of advanced (unresectable or metastatic) melanoma.
• Patient initiated a first-line therapy for the treatment of advanced melanoma during the eligibility period (01 July 2016 to 01 July 2017; index event).
• Patient did not receive systemic treatment for their advanced (unresectable or metastatic) melanoma prior to index event
• Patient initiated first-line therapy at least six months before the date their chart abstraction initiated

Exclusion Criteria

• Patient was enrolled in an investigational drug clinical trial or participating in medical research judged to directly affect how the patient was being monitored/treated while receiving first-line therapy
• Patient had another active concurrent malignancy other than advanced melanoma, which required systemic treatment at the time of index event
• Part or all of the patient's first-line treatment was received at a different site and the patient's medical chart pertaining to this care is not accessible
• Patient medical chart is missing, empty, or not retrievable

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Local Institution

Cambridge, Cambridgeshire, United Kingdom

Countries

United Kingdom

Related Links

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bms.com/researchers-and-partners/investigator-inquiry-form.html

Investigator Inquiry Form

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

CA209-9TW

Identifier Type: -

Identifier Source: org_study_id