CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 275 enrolled
Drug / intervention
Enco+binidrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05954546
NCT05954546N/ACompleted

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

Pfizer·observational·Posted Jul 20, 2023·Updated Feb 5, 2025

In Brief

An observational study evaluating Enco+bini for Metastatic Melanoma. Completed, enrolled 275 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedJul 20, 2023
Enrollment StartJul 21, 2023
Primary CompletionDec 31, 2023
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 2.9 years ago

Interventions

Enco+binidrug

Patients with BRAF mutant + receiving encorafenib and binimetinib combination treatment