Comparative Effectiveness of Targeted Therapies in BRAF Positive Metastatic Melanoma in the US (OCEANMIST)

Pfizer

Status

Completed

Conditions

Melanoma

Treatments

Drug: Dabrafenib

Drug: Vemurafenib

Drug: Cobimetinib

Drug: Binimetinib

Drug: Trametinib

Drug: Encorafenib

Study type

Observational

Funder types

Industry

Identifiers

NCT05260684

OCEANMIST (Other Identifier)

C4221028

Details and patient eligibility

About

This study aims to compare real-world effectiveness of BRAF/MEK inhibitors in BRAF-mutant metastatic melanoma patients in the United States by line of therapy.

The Flatiron Health electronic health record (EHR) data from US cancer clinics will be used for this retrospective database analysis.

Enrollment

1 patient

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosed with melanoma based on International Classification of Disease 9th and 10th Revisions (ICD-9: 172.x; ICD-10: C43x, D03x) and ≥2 visits on different days in the Flatiron database on or after January 1, 2011.
Clinically confirmed diagnosis of melanoma with pathologic stages III or IV at initial diagnosis or earlier stage disease with a first locoregional or distant recurrence on or after January 1, 2011.
Age ≥18 years at the time of advanced melanoma diagnosis.
Evidence of ≥1 BRAF positive test result at any time based on laboratory or genetic analysis results.

Exclusion criteria

-• Patients with prior BRAF- or MEK-inhibitor therapy

• Patients with ECOG performance status ≥ 2 (at the time of randomization for patients from COLUMBUS, during the baseline period for patients in Flatiron EHR)