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

Metastatic Melanoma Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05954546
• Other study ID #: C4221035
• Status: Active, not recruiting
• Start date: July 21, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Metastatic Melanoma

Intervention

Drug:
• Enco+bini
Patients with BRAF mutant + receiving encorafenib and binimetinib combination treatment

Locations

Country	Name	City	State
United States	Pfizer	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		June 2018 through Jan 2022

External Links

•   To obtain contact information for a study center near you, click here.