UK ENcorafenib and BInimetinib Real-world Study in Melanoma
NCT ID: NCT07022457
Last Updated: 2025-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2025-07-31
2028-01-13
Brief Summary
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Detailed Description
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The COLUMBUS trial has demonstrated the efficacy and safety profile of encorafenib plus binimetinib in patients with advanced melanoma with a BRAFV600 mutation; the 7-year analysis of this study is currently available. Real-world studies can reach broader patient populations than are typical of clinical trials, and also provide unique insights, such as real-life challenges faced by patients, the impact of a disease on productivity, and daily disease management. Given the importance of patient health-related quality of life (HRQoL) data in melanoma treatment and the potential value of real-world evidence (RWE), Pierre Fabre wishes to complement the clinical and HRQoL outcomes demonstrated for encorafenib plus binimetinib in the COLUMBUS trial with patient-reported outcomes (PROs) data from a real-world study.
The source population will be patients being treated for melanoma in National Health Service (NHS) England secondary care centers at the time of study enrolment. Approximately 8 study sites will be selected from the available secondary care centers, based on clinical experience with encorafenib plus binimetinib, research capacity, and willingness to take part.
Patients who are interested in participating in the study will be able to download the Vitaccess Real™ application either during their consultation at the site or at their own convenience. After completing the in-application informed consent process, they will be able to begin data entry via the application. Site research teams will complete an electronic case report form (eCRF) for each participant at baseline, using data from the participant's electronic medical record (EMR). For analysis purposes, data from the eCRF will be linked to the participant-reported data using the participant's assigned unique ID and PIN number.
Conditions
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Study Design
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ECOLOGIC_OR_COMMUNITY
PROSPECTIVE
Study Groups
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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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Patients participating in a clinical trial
18 Years
ALL
No
Sponsors
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Vitaccess Ltd
INDUSTRY
Pierre Fabre Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Andrew Furness, MBBS, MRCP, PhD
Role: PRINCIPAL_INVESTIGATOR
Royal Marsden NHS Foundation Trust
Tarandeep Singh Matharu, MPharm, PgCert
Role: STUDY_DIRECTOR
Pierre Fabre Limited
Locations
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Southend University Hospital
Westcliff-on-Sea, Essex, 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
Countries
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Central Contacts
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Other Identifiers
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5126-10-2024
Identifier Type: -
Identifier Source: org_study_id
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