Status:
COMPLETED
Comparative Effectiveness of Targeted Therapies in BRAF Positive Metastatic Melanoma in the US
Lead Sponsor:
Pfizer
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Brief 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 r...
Eligibility Criteria
Inclusion
- 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
- • 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)
Key Trial Info
Start Date :
January 17 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
716 Patients enrolled
Trial Details
Trial ID
NCT05260684
Start Date
January 17 2022
End Date
December 31 2023
Last Update
March 6 2025
Active Locations (1)
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1
Pfizer Investigational Site
New York, New York, United States, 10017