System Maintenance Notice

Please note that maintenance work is scheduled between 4 AM and 5 AM - CET. During this time, you may experience reduced performance. Thanks for your patience.

Studies

Observational Active not recruiting

NCT07022457 on ClinicalTrials.gov

UK ENcorafenib and BInimetinib Real-world Study in Melanoma

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

  • Sponsor: Pierre Fabre (Group)
  • Collaborators: Vitaccess Ltd
  • Enrollment: 50 (Estimated)
  • Study start: 2025-07-31 (Actual)
  • Primary completion: 2028-01-13 (Estimated)
  • Study completion: 2028-01-13 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

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

Intervention / Treatment

  • Biological: Encorafenib + Binimetinib

Primary Outcome Measures

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

Countries

United Kingdom

Locations and Investigators

  • Southend University Hospital, Westcliff-on-Sea, 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

Study Officials