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

Completed

• Conditions: Metastatic Melanoma

• Registration Number: NCT05954546
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-12
• Study First Submitted QC: 2023-07-12
• Study First Posted: 2023-07-20
• Study Start: 2023-07-21
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Results First Submitted: 2024-11-25
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-03
• Last Update Submitted: 2025-02-03
• Results First Posted: 2025-03-25
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 275

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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 (approx 42.2 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; 🇺🇸 New York, New York, United States