RecruitingNCT07022457

UK ENcorafenib and BInimetinib Real-world Study in Melanoma

UK ENcorafenib and BInimetinib Real-world Study in Melanoma (UK-EnBiRiM): A Prospective Observational Real-world App-based Study to Explore HRQoL Outcomes, of Adults With Metastatic Cutaneous BRAF V600 Mutation-positive Melanoma, Initiated on Combination Encorafenib and Binimetinib Therapy in the UK

Sponsor

Pierre Fabre Ltd

Enrollment

50 participants

Start Date

Jul 31, 2025

Study Type

OBSERVATIONAL

Conditions

Metastatic Melanoma, BRAF V600 Mutation Positive

Summary

This is a prospective longitudinal multi-centre observational study conducted in the United Kingdom, in patients with metastatic cutaneous BRAF V600 mutation-positive melanoma assigned to receive encorafenib and binimetinib. The aim of this study is to learn about how encorafenib and binimetinib perform, patients' experiences of using them, and how they might affect patient's quality of life, in the real world, when these treatments are prescribed by doctors instead of in a clinical trial. Participants will complete electronic data entry via questionnaires over a 24-month period. Site research teams will also complete electronic data entry using participants' medical records over a 24-month period.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This UK real-world study (UKENBI) is following patients with metastatic melanoma carrying a BRAF V600 mutation who are starting treatment with encorafenib plus binimetinib (a targeted therapy combination) as a second-line treatment, to track outcomes, side effects, and quality of life in everyday clinical practice. **You may be eligible if...** - You are 18 or older - You have metastatic cutaneous (skin) melanoma with a confirmed BRAF V600 mutation - Your doctor has decided to start you on encorafenib plus binimetinib as your second-line treatment - You have a smartphone and are willing to participate **You may NOT be eligible if...** - You are receiving systemic treatment for any cancer other than melanoma - You are currently enrolled in another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALEncorafenib + Binimetinib

Participants will have received a clinical decision to begin encorafenib plus binimetinib treatment as a second-line treatment for metastatic melanoma, in accordance with current Summary of Product Characteristics

Locations(7)

Southend University Hospital

Westcliff-on-Sea, Essex, United Kingdom

Queen Elizabeth Hospital

Birmingham, United Kingdom

Addenbrookes Hospital

Cambridge, United Kingdom

University Hospital Coventry and Warwickshire

Coventry, United Kingdom

Royal Marsden Hospital

London, United Kingdom

Royal Preston Hospital

Preston, United Kingdom

Southampton General Hospital

Southampton, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07022457