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Trial Information

Status:

Open

Specialty:

Skin

Date Opened:

31/07/2025

Planned Close date:

31/10/2025

Sponsors:

Pierre Fabre Ltd

Site Recruitment:

7 /

4

Principal Investigator:

Dr Kellati Prasad

Study Title:

Real-world outcomes of encorafenib plus binimetinib treatment

Contacts

Research Nurse / Study Coordinator:

Sirjana Devkota

Administrator:

Zahir Shah

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 unresectable or metastatic cutaneous BRAF V600 mutation-positive melanoma, initiated on combination encorafenib and binimetinib therapy in the UK

This is a prospective longitudinal multi-centre observational study conducted in the UK, in patients with metastatic cutaneous BRAF V600 mutation-positive melanoma. Longitudinal data capture will permit exploration of the impact of treatment with encorafenib plus binimetinib over time, while an observational study design will ensure that the data reflect the real-world setting.

• Aged 18 years or older.
• Willing and capable of providing written informed consent.
• Access to a smartphone.
• Diagnosis of metastatic cutaneous melanoma with presence of BRAF V600 mutation in tumour tissue prior to enrolment.
• Clinical decision has been made to begin encorafenib plus binimetinib treatment in accordance with current Summary of Product Characteristics.
• Encorafenib plus binimetinib to be prescribed as second-line treatment for BRAF V600-mutant metastatic melanoma.

• Patients receiving systemic treatment for any tumours other than melanoma.
• Patients participating in a clinical trial.