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RECRUITING
NCT07022457

UK ENcorafenib and BInimetinib Real-world Study in Melanoma

Sponsor: Pierre Fabre Ltd

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2025-07-31

Completion Date

2028-01-13

Last Updated

2025-08-03

Healthy Volunteers

No

Interventions

BIOLOGICAL

Encorafenib + 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