Active Cancer NIHR-supported project Digestion, Kidneys & Other Organs

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 unresectable or metastatic cutaneous BRAF V600 mutation-positive melanoma, initiated on combination encorafenib and binimetinib?therapy in the UK

Funder NIHR (part of DHSC)
Recipient organisation NIHR Cambridge Biomedical Research Centre
NIHR support Recorded as supported by this research centre
Period Jan 2025 — May 2027

In plain English

AI plain-English summary

People prescribed a specific two-drug combination for advanced melanoma will track their symptoms and daily lives through a smartphone app, rather than through hospital visits, to reveal how the treatment truly affects them outside clinical trials. This matters because clinical trials, while rigorous, often miss the messy reality of how patients actually feel and function at home. The drug combination encorafenib and binimetinib is already approved for BRAF V600 mutation-positive melanoma based on trial data, but doctors and the drug’s manufacturer, Pierre Fabre, lack detailed, real-world evidence on quality of life, symptom burden, and ability to carry out daily activities over time. Without this, treatment decisions may overlook side effects or benefits that only emerge in everyday life. If the study succeeds, it will provide UK-specific, patient-reported data that could help clinicians tailor melanoma care more precisely—for example, by adjusting dosing or support based on real-world experiences. It also demonstrates a scalable model for using smartphone apps to collect long-term health data, potentially reducing the need for frequent hospital visits. This approach could be adapted for other cancers or chronic conditions, quietly improving how healthcare systems monitor treatment effectiveness without adding burden to patients or clinics.

View original technical description
The main aim of this study is to learn about the quality of life and wellbeing of people who are prescribed melanoma treatment combination encorafenib and binimetinib, and track whether these things change over time. The study sponsor, Pierre Fabre, would like to learn more about how encorafenib and binimetinib perform, and patients’ experiences of using them, in the real world, when they are prescribed by doctors instead of in a clinical trial. The information from this study will provide evidence from a UK-specific real-life setting to support data from clinical trials, which showed the efficacy and safety profile of encorafenib and binimetinib leading to its regulatory approval in the current licensed indications.The study is recruiting participants are 18 years old or older who have been diagnosed with metastatic melanoma on the skin with a BRAF V600 mutation, and have been prescribed encorafenib and binimetinib as a second treatment for metastatic melanoma. Eligible participants will be recruited from up to 8 NHS secondary care centers. The research team at each site will brief participants about the study and interested participants will download the study app and provide informed consent to take part.Participants will use the app to answer background questions about themselves to help researchers to better understand the rest of the data they share during the study. They will then be asked to fill in surveys about their symptoms, health, and ability to carry about daily activities. These will help Pierre Fabre learn about the effects of melanoma and its treatment on participants’ quality of life. Participants will be asked to remain in the study for approximately two years and complete these surveys every two months for the first six months of the study, then every three months after that.

Researchers

Nicola Thompson (Principal Investigator)

Related Research

Grants with similar aims, by meaning.

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 (EnBIRIM)
Portside C4221023 - A phase 2, randomized, open-label study of Encorafenib and Binimetinib plus Pembrolizumab versus Nivolumab and Ipilimumab in participants with BRAF V600E/K mutation-positive melanoma who progressed during or after prior treatment with anti-PD-1 therapy
A phase 2, randomized, open-label study of encorafenib and binimetinib plus pembrolizumab versus nivolumab and ipilimumab in participants with braf v600e/k mutation-positive melanoma who progressed during or after prior treatment with anti?pd-1 therapy
A phase 2, randomized, open-label study of encorafenib andbinimetinib plus pembrolizumab versus nivolumab andipilimumab in participants with braf v600e/k mutation-positivemelanoma who progressed during or afterprior treatment with anti?pd-1 therapy
DyNAMIc - Circulating tumour DNA guided Adaptive BRAF and MEK Inhibitor therapy

Original classification

Cancer

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