Metastatic Melanoma, BRAF V600 Mutation PositiveUK-EnBiRiMNCT07022457
UK ENcorafenib and BInimetinib Real-world Study in Melanoma
An observational study of Metastatic Melanoma, BRAF V600 Mutation Positive, run by Pierre Fabre Ltd at 7 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma, BRAF V600 Mutation Positive
- What is being tested?
- Encorafenib + Binimetinib
- How many people
- 50 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- 31 Jul 2025to 13 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Patients receiving systemic treatment for any tumours other than melanoma
- Patients participating in a clinical trial
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United Kingdom7 sites
Queen Elizabeth Hospital
Birmingham, B152GW
Addenbrookes Hospital
Cambridge, CB20QQ
University Hospital Coventry and Warwickshire
Coventry, CV22DX
Royal Marsden Hospital
London, SW36JJ
Royal Preston Hospital
Preston, PR26GP
Southampton General Hospital
Southampton, SO166YD
Southend University Hospital
Westcliff-on-Sea, Essex, SS00RY
About this study
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
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.
Read the detailed description
This longitudinal study will collect real-world clinical outcomes and patient-reported outcomes (PRO) data for patients receiving encorafenib plus binimetinib. The results from the study will be summarized descriptively to describe the impact of encorafenib plus binimetinib in the UK real-world setting.
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.
- Being tested
- Encorafenib + Binimetinib
- Keywords
- Melanoma, BRAF V600, HRQoL, PROs, Encorafenib, Binimetinib, Real-World, prospective
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Encorafenib + BinimetinibBiological
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Encorafenib + Binimetinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the change from baseline over 24 months of FACT-Melanoma (FACT-M) scores of patients initiated on encorafenib plus binimetinib
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).
Measured: 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)
Secondary outcomes (11)
Describe patient demographics
Assessed using demographic data reported by participants via the QOL-MUK platform (including; month and year of birth, sex and ethnicity).
Measured: Once, at baseline
Describe patient baseline clinical characteristics
Assessed using electronic medical record (EMR) data reported by healthcare professionals (HCPs) ("Disease history", "Statuses" and "Treatment history" surveys).
Measured: Once, at baseline
Describe median duration of treatment with encorafenib and binimetinib
Assessed using electronic medical record (EMR) data reported by healthcare professionals (HCPs) ("Treatment history" and "Treatment status" surveys).
Measured: Every three months (±7 days) for 24 months, starting three months from baseline
Describe change from baseline over 24 months of EQ-5D-5L scores of patients receiving encorafenib plus binimetinib
EQ-5D-5L instrument data reported by patients via the QOL-MUK platform ("General health" survey). The instrument comprises two parts. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with 5 levels (1 - no problems, 2 - slight problems, 3 - moderate problems, 4 - severe problems, and 5 - extreme problems). The digits for 5 dimensions can be combined in a 5-digit number describing the health state of the person.
Measured: Every eight weeks (±7 days) from baseline for first six months; every three months (±7 days) for the remaining 18 months (24 months total)
Describe changes in patient self-reported symptom severity over 24 months using the Patient Global Impression of Severity (PGI-S)
PGI-S instrument data will be reported by patients via the QOL-MUK platform ("Symptom severity" survey). This is a generic instrument used to assess self-perceived severity of a specific condition, with the following response options: None, Mild, Moderate, Severe, Very Severe.
Measured: Every eight weeks (±7 days) from baseline for first six months; every three months (±7 days) for the remaining 18 months (24 months total)
Describe the median time from baseline to definitive 10% deterioration of the FACT-M scores of patients receiving encorafenib plus binimetinib using Kaplan-Meier analysis
FACT-M instrument data reported by patients via the QOL-MUK platform ("Impact of melanoma on well-being" survey). A 10% deterioration is defined as a deterioration of at least 10% in total FACT-M score. The total FACT-M score ranges from 0 to 172. The higher the FACT-M score, the better the QOL.
Measured: Every eight weeks (±7 days) from baseline for first six months; every three months (±7 days) for the remaining 18 months (24 months total)
Describe the median time from baseline to definitive 10% deterioration of the EQ-5D-5L scores of patients receiving encorafenib plus binimetinib using Kaplan-Meier analysis
EQ-5D-5L instrument data will be reported by patients via the QOL-MUK platform ("General health" survey). A 10% deterioration is defined as a deterioration of at least 10% in the utility index score for EQ-5D-5L. EQ-5D-5L utility index scores range from 0 to 1; higher index scores indicate a higher health utility.
Measured: Every eight weeks (±7 days) from baseline for first six months; every three months (±7 days) for the remaining 18 months (24 months total)
Describe reasons why encorafenib plus binimetinib treatment may be discontinued
Assessed using electronic medical record (EMR) data reported by healthcare professionals (HCPs) ("Treatment status" survey).
Measured: Every three months (±7 days) for 24 months, starting three months from baseline
Describe real-world progression-free survival (PFS) and overall survival (OS) of patients receiving encorafenib plus binimetinib using Kaplan-Meier analysis
Assessed using electronic medical record (EMR) data reported by healthcare professionals (HCPs) ("Clinical outcomes" survey).
Measured: Every three months (±7 days) for 24 months, starting three months from baseline
Describe the presence of melanoma brain metastases (MBM) at the beginning of study and the development and/or progression of MBM in patients receiving encorafenib plus binimetinib
Assessed using electronic medical record (EMR) data reported by healthcare professionals (HCPs) ("Clinical outcomes" survey), specifically whether melanoma has metastasized to brain since previous assessment; if new MBM, date of metastasis; if existing MBM, whether intracranial progression; if yes, date of intracranial progression.
Measured: Every three months (±7 days) for 24 months, starting three months from baseline
Describe adverse events (AEs) experienced by patients receiving encorafenib plus binimetinib
This will be assessed via the contents of Pierre Fabre solicited AE collection form, including type of AE and grade/severity.
Measured: Within 24 hours of becoming aware of AEs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start31 Jul 2025
- Primary completion13 Jan 2028 (estimated)
- Study completion13 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Melanoma, BRAF V600 Mutation PositiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vitaccess Ltd
- Responsible party
- Sponsor
- Investigators
- Andrew Furness, MBBS, MRCP, PhD, Principal investigator, Royal Marsden NHS Foundation TrustTarandeep Singh Matharu, MPharm, PgCert, Study director, Pierre Fabre Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022457
- Sponsor's protocol ID
- 5126-10-2024
- Acronym
- UK-EnBiRiM
- Status last verified
- Jul 2025
- First submitted
- 16 May 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07022457
- Acronym / sponsor ID
- UK-EnBiRiM / 5126-10-2024
- Keywords
- Melanoma, BRAF V600, HRQoL, PROs, Encorafenib, Binimetinib, Real-World, prospective
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Pierre Fabre LtdIndustry (pharma, biotech, devices)
- Collaborators
- Vitaccess Ltd
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- 13 Jan 2028 (estimated)
- Study completion
- 13 Jan 2028 (estimated)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This longitudinal study will collect real-world clinical outcomes and patient-reported outcomes (PRO) data for patients receiving encorafenib plus binimetinib. The results from the study will be summarized descriptively to describe the impact of encorafenib plus binimetinib in the UK real-world setting.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UK-EnBiRiM study participants | – | Biological: Encorafenib + BinimetinibAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Patients receiving systemic treatment for any tumours other than melanoma
- Patients participating in a clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Encorafenib + BinimetinibParticipants 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 | Biological | UK-EnBiRiM study participants |
Primary outcome
Describe the change from baseline over 24 months of FACT-Melanoma (FACT-M) scores of patients initiated on encorafenib plus binimetinib
Time frame: 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).
11 secondary outcomes
Describe patient demographics
Time frame: Once, at baseline
Describe patient baseline clinical characteristics
Time frame: Once, at baseline
Describe median duration of treatment with encorafenib and binimetinib
Time frame: Every three months (±7 days) for 24 months, starting three months from baseline
Describe change from baseline over 24 months of EQ-5D-5L scores of patients receiving encorafenib plus binimetinib
Time frame: Every eight weeks (±7 days) from baseline for first six months; every three months (±7 days) for the remaining 18 months (24 months total)
Describe changes in patient self-reported symptom severity over 24 months using the Patient Global Impression of Severity (PGI-S)
Time frame: Every eight weeks (±7 days) from baseline for first six months; every three months (±7 days) for the remaining 18 months (24 months total)
Describe the median time from baseline to definitive 10% deterioration of the FACT-M scores of patients receiving encorafenib plus binimetinib using Kaplan-Meier analysis
Time frame: Every eight weeks (±7 days) from baseline for first six months; every three months (±7 days) for the remaining 18 months (24 months total)
Describe the median time from baseline to definitive 10% deterioration of the EQ-5D-5L scores of patients receiving encorafenib plus binimetinib using Kaplan-Meier analysis
Time frame: Every eight weeks (±7 days) from baseline for first six months; every three months (±7 days) for the remaining 18 months (24 months total)
Describe reasons why encorafenib plus binimetinib treatment may be discontinued
Time frame: Every three months (±7 days) for 24 months, starting three months from baseline
Describe real-world progression-free survival (PFS) and overall survival (OS) of patients receiving encorafenib plus binimetinib using Kaplan-Meier analysis
Time frame: Every three months (±7 days) for 24 months, starting three months from baseline
Describe the presence of melanoma brain metastases (MBM) at the beginning of study and the development and/or progression of MBM in patients receiving encorafenib plus binimetinib
Time frame: Every three months (±7 days) for 24 months, starting three months from baseline
Describe adverse events (AEs) experienced by patients receiving encorafenib plus binimetinib
Time frame: Within 24 hours of becoming aware of AEs
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Furness, MBBS, MRCP, PhD principal investigator
Royal Marsden NHS Foundation Trust
Tarandeep Singh Matharu, MPharm, PgCert study director
Pierre Fabre Limited
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Melanoma, BRAF V600 Mutation Positive, run by Pierre Fabre Ltd at 7 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the change from baseline over 24 months of FACT-Melanoma (FACT-M) scores of patients initiated on encorafenib plus binimetinib (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.