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UK ENcorafenib and BInimetinib Real-world Study in Melanoma

NCT07022457 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-04-13

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Vitaccess Ltd

    collaborator INDUSTRY

  • Pierre Fabre Ltd

    lead INDUSTRY

Principal Investigators

  • Andrew Furness, MBBS, MRCP, PhD · Royal Marsden NHS Foundation Trust

  • Tarandeep Singh Matharu, MPharm, PgCert · Pierre Fabre Limited

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2028-01-13
Completion
2028-01-13
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07022457 on ClinicalTrials.gov