NCT05954546

A Study to Compare How Effective is Encorafenib Plus Binimetinib in Real-world and Clinical Trial Settings

Overall Survival (OS) in Patients With Metastatic BRAFV600-mutant Melanoma Treated With Encorafenib Plus Binimetinib in the COLUMBUS Trial Versus in Real-world Practice Data

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 275 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Brief summary The purpose of this study is to compare how effective, encorafenib plus binimetinib is in the real-world and clinical trial settings. And produce results to show that combining data on encorafenib plus binimetinib from both the real-world and clinical trial settings is possible for future research studies. This study group is identified from the database who: * Have taken at least 1 order or administration of encorafenib plus binimetinib treatment after the confirmation of having metastatic melanoma after 27 June 2018. * Are at least 18 years of age at the time of first encorafenib plus binimetinib initiation (index date). * Had never received encorafenib plus binimetinib or had received first-line immunotherapy at the start of the study. * Have ECOG status of 0 or 1 at the index date. * have available data on the number of deaths in an area or group of people. Patients will be followed from the date that the patient started the first encorafenib plus binimetinib treatment (treatment initiation) up to their last date of data availability. Last date of data availability could be the date of following events: patient lost to follow up at the clinic, death, or end of the database (January 2020). The database timeframe is June 2018 to January 2020.

Conditions

• Metastatic Melanoma

Interventions

Type	Name	Description
DRUG	Enco+bini	Patients with BRAF mutant + receiving encorafenib and binimetinib combination treatment

Timeline

• Start date: 2023-07-21
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2023-07-20
• Last updated: 2025-02-05
• Results posted: 2025-02-05

Locations

1 site across 1 country: United States