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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Biological
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Queen Elizabeth Hospital
RECRUITING
Birmingham
Addenbrookes Hospital
RECRUITING
Cambridge
University Hospital Coventry and Warwickshire
NOT_YET_RECRUITING
Coventry
Royal Marsden Hospital
RECRUITING
London
Royal Preston Hospital
RECRUITING
Preston
Southampton General Hospital
RECRUITING
Southampton
Southend University Hospital
NOT_YET_RECRUITING
Westcliff-on-sea
Contact Information
Primary
Mark J W Larkin, PhD
mark.larkin@vitaccess.com
+44 1865818983
Backup
Akosua Ofori, MPH
akosua.ofori@vitaccess.com
+44 1865818983
Time Frame
Start Date: 2025-07-31
Estimated Completion Date: 2028-01-13
Participants
Target number of participants: 50
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Vitaccess Ltd
Leads: Pierre Fabre Ltd

This content was sourced from clinicaltrials.gov