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

Completed

• Conditions: Melanoma
• Interventions: Drug: Encorafenib; Drug: Dabrafenib; Drug: Vemurafenib; Drug: Binimetinib; Drug: Cobimetinib; Drug: Trametinib

• Registration Number: NCT05260684
• Lead Sponsor: Pfizer

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 record (EHR) data from US cancer clinics will be used for this retrospective database analysis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-11
• Study Start: 2022-01-17
• Study First Submitted QC: 2022-02-18
• Study First Posted: 2022-03-02
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Results First Submitted: 2024-12-17
• Status Verified: 2025-03
• Results First Submitted QC: 2025-03-03
• Last Update Submitted: 2025-03-03
• Results First Posted: 2025-03-06
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 716

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Encorafenib + binimetinib	Encorafenib	Encorafenib 450 mg once a day (QD) Binimetinib 45 mg twice a day (BID)
Encorafenib + binimetinib	Binimetinib	Encorafenib 450 mg once a day (QD) Binimetinib 45 mg twice a day (BID)
Vemurafenib + Cobimetinib	Cobimetinib	Vemurafenib 960 mg twice a day (BID) for 28 days of 28 day cycle Cobimetinib 60 mg once a day (QD) for 21 days of 28 day cycle
Dabrafenib + trametinib	Dabrafenib	Dabrafenib 150 mg twice a day (BID) Trametinib 2 mg once a day (QD)
Vemurafenib + Cobimetinib	Vemurafenib	Vemurafenib 960 mg twice a day (BID) for 28 days of 28 day cycle Cobimetinib 60 mg once a day (QD) for 21 days of 28 day cycle
Dabrafenib + trametinib	Trametinib	Dabrafenib 150 mg twice a day (BID) Trametinib 2 mg once a day (QD)

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	COLUMBUS: From date of randomization until death or censoring (approx 80.5 months); Flatiron: From index date until death due or censoring or end of follow-up period (92.7 months)	As per COLUMBUS trial, OS was defined as the time from the date of randomization to the date of death due to any cause; if death was not observed, participants were censored at the date of last contact or the data analysis cut-off date, whichever occurred first. As per Flatiron EHR, OS was defined as the time from the index date to the date of death; participants without a date of death were censored at their last known activity date or the end of the follow-up period, whichever occurred first. Index date in each treatment group was defined as the date of treatment initiation. Kaplan-Meier analyses was used for analysis.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New York, New York, United States