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

NCT05954546 | Completed Results

• 1 other identifier: C4221035
• Study Type: observational
• Target: 275
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Melanoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  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.

  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)

Interventions

Enco+bini DRUG

Patients with BRAF mutant + receiving encorafenib and binimetinib combination treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with BRAF mutant + metastatic melanoma receiving encorafenib and binimetinib

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

New York, New York, 10017, United States

Location

Related Links

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

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: July 20, 2023
• Study Start: July 21, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 5, 2025
• Results First Posted: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)