Real-world outcomes of encorafenib plus binimetinib treatment
Research type
Research Study
Full 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 unresectable or metastatic cutaneous BRAF V600 mutation-positive melanoma, initiated on combination encorafenib and binimetinib therapy in the UK
IRAS ID
325148
Contact name
Andrew Furness
Contact email
Sponsor organisation
Pierre Fabre Limited
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 8 months, 0 days
Research summary
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 12 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.
REC name
Seasonal REC
REC reference
23/LO/0724
Date of REC Opinion
26 Sep 2023
REC opinion
Further Information Favourable Opinion