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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metastatic Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

New York, 10017, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosis of melanoma (International Classification of Diseases 9th or 10th Revision Clinical Modification - ICD-9-CM: 172.X; ICD-10-CM: C43.x) and secondary malignancy or metastasis (ICD-9-CM: 196.x, 197.x, 198.x; ICD-10-CM: C77.x, C78.x, C79.x).
Confirmed BRAF V600E/V600K activating mutation reported in the data based on laboratory or genetic analysis results.
At least 1 order or administration of ENCO+BINI treatment

Exclusion criteria

Patients without information on mortality
Patients with ECOG performance status ≥ 2 (at the time of randomization for patients from COLUMBUS, during the baseline period for patients in Flatiron Electronic Health Record)
Patients with a history of or concurrent uveal or mucosal melanoma, basal cell or squamous cell carcinoma (as per trial inclusion criteria); this exclusion will also be applied to RWD patients

Treatment and study plan

Enco+bini

Drug

Patients with BRAF mutant + receiving encorafenib and binimetinib combination treatment

Primary outcomes

Overall Survival (OS)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Jul 20, 2023
Registry last updated: Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed