UK ENcorafenib and BInimetinib Real-world Study in Melanoma

NCT07022457 | Active Not Recruiting FDA Drug

• 1 other identifier: 5126-10-2024
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Metastatic Melanoma, BRAF V600 Mutation Positive

Keywords

Melanoma; BRAF V600; HRQoL; PROs; Encorafenib; Binimetinib; Real-World; prospective

Outcome Measures

Primary Outcomes (1)

• Describe the change from baseline over 24 months of FACT-Melanoma (FACT-M) scores of patients initiated on encorafenib plus binimetinib

  FACT-M instrument data reported by patients via the Quality of Life - Melanoma in the UK (QOL-MUK) platform ("Impact of melanoma on well-being" survey). The FACT-M contains 24-items reported on a 5-point Likert-type scale ("Not at all", "A little bit", "Somewhat", "Quite a bit", and "very much"). The outcome measure contains the 3 QoL domains; 20 items relate to physical well-being, 3 to emotional well-being, and 1 to social well-being. The higher the score, the better the quality of life (QOL).

  Every eight weeks (±7 days) from baseline for first 6 months; every 3 months (±7 days) thereafter for the remaining 18 months (24 months total)

Secondary Outcomes (11)

• Describe patient demographics

  Once, at baseline

• Describe patient baseline clinical characteristics

  Once, at baseline

• Describe median duration of treatment with encorafenib and binimetinib

  Every three months (±7 days) for 24 months, starting three months from baseline

• Describe change from baseline over 24 months of EQ-5D-5L scores of patients receiving encorafenib plus binimetinib

  Every eight weeks (±7 days) from baseline for first six months; every three months (±7 days) for the remaining 18 months (24 months total)

• Describe changes in patient self-reported symptom severity over 24 months using the Patient Global Impression of Severity (PGI-S)

  Every eight weeks (±7 days) from baseline for first six months; every three months (±7 days) for the remaining 18 months (24 months total)

Study Arms (1)

UK-EnBiRiM study participants

Adult patients diagnosed with metastatic cutaneous BRAF V600 mutation-positive melanoma and assigned to receive encorafenib plus binimetinib as second-line treatment for metastatic melanoma, as per current Summary of Product Characteristics.

Biological: Encorafenib + Binimetinib

Interventions

Encorafenib + Binimetinib BIOLOGICAL

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

UK-EnBiRiM study participants

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

Adult patients diagnosed with metastatic cutaneous BRAF V600 mutation-positive melanoma and assigned to receive encorafenib plus binimetinib as second-line treatment for metastatic melanoma, as per current Summary of Product Characteristics.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Pierre Fabre Ltd: lead
• Vitaccess Ltd: collaborator

Study Sites (7)

Southend University Hospital

Westcliff-on-Sea, Essex, SS00RY, United Kingdom

Location

Queen Elizabeth Hospital

Birmingham, B152GW, United Kingdom

Location

Addenbrookes Hospital

Cambridge, CB20QQ, United Kingdom

Location

University Hospital Coventry and Warwickshire

Coventry, CV22DX, United Kingdom

Location

Royal Marsden Hospital

London, SW36JJ, United Kingdom

Location

Royal Preston Hospital

Preston, PR26GP, United Kingdom

Location

Southampton General Hospital

Southampton, SO166YD, United Kingdom

Location

MeSH Terms

Conditions

Melanoma

Interventions

encorafenib; binimetinib

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

Study Officials

• Andrew Furness, MBBS, MRCP, PhD

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Tarandeep Singh Matharu, MPharm, PgCert

  Pierre Fabre Limited

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: June 15, 2025
• Study Start: July 31, 2025
• Primary Completion (Estimated): January 13, 2028
• Study Completion (Estimated): January 13, 2028
• Last Updated: April 13, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (7)