NCT05260684Completed
Comparative Effectiveness of Targeted Therapies in BRAF Positive Metastatic Melanoma in the US
Comparative Effectiveness of Different Targeted Therapies for BRAF-mutated Unresectable/Metastatic Melanoma in the United States
Source: ClinicalTrials.gov · Last updated 6 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 716 (actual)
- First submitted
- 11 Jan 2022
- Start date
- 17 Jan 2022
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Pfizer
- Diseases
- Melanoma
- NCT number
- NCT05260684
What you commit to
- Study type: Observational
- Participants enrolled: 716
- From 17 Jan 2022 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- -• Patients with prior BRAF- or MEK-inhibitor therapy
Other
- Patients with ECOG performance status ≥ 2 (at the time of randomization for patients from COLUMBUS, during the baseline period for patients in Flatiron EHR)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.