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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Melanoma

Treatments: Other: Non-interventional

Study type: Observational

Funder types: Industry

Identifiers

NCT03448497

CA209-9TW

Details and patient eligibility

About

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.

Enrollment: 333 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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

Other protocol defined inclusion/exclusion criteria could apply

Trial design

333 participants in 1 patient group

Advanced Melanoma patients who intiated first-line therapy

Description:

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

Treatment:

Other: Non-interventional