N/A
N=716
Comparative Effectiveness of Targeted Therapies in BRAF Positive Metastatic Melanoma in the US
Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT05260684 ↗Enrolled (actual)
716
Serious AEs
—
Results posted
Mar 2025
Primary outcome: Primary: Overall Survival (OS) — 16.1; 25.0; 30.0 Months — p=0.02
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Encorafenib (Drug); Binimetinib (Drug); Vemurafenib (Drug); Cobimetinib (Drug); Dabrafenib (Drug); Trametinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
16.1; 25.0; 30.0 | 0.02 sig |
Summary
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT05260684). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.