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UK ENcorafenib and BInimetinib Real-world Study in Melanoma
Sponsor: Pierre Fabre Ltd
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
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