NCT07022457Active, not recruiting
UK ENcorafenib and BInimetinib Real-world Study in Melanoma
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
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 16 May 2025
- Start date
- 31 Jul 2025
- Primary completion date
- 13 Jan 2028
- Lead sponsor
- Pierre Fabre Ltd
- Diseases
- Melanoma
- NCT number
- NCT07022457
What you commit to
- Study type: Observational
- Planned participants: 50
- From 31 Jul 2025 to the primary completion date, 13 Jan 2028
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients receiving systemic treatment for any tumours other than melanoma
Other
- Patients participating in a clinical trial
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Queen Elizabeth Hospital Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Addenbrookes Hospital Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| University Hospital Coventry and Warwickshire Coordinator of this site? Confirm its status | Coventry | United Kingdom | Unknown status |
| Royal Marsden Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Royal Preston Hospital Coordinator of this site? Confirm its status | Preston | United Kingdom | Unknown status |
| Southampton General Hospital Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
| Southend University Hospital Coordinator of this site? Confirm its status | Westcliff-on-Sea | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.