Active not recruitingOBSERVATIONAL

UK ENcorafenib and BInimetinib Real-world Study in Melanoma

This UK study is observing how a specific treatment for advanced melanoma, called encorafenib and binimetinib, works in patients with a particular gene change (BRAF V600 mutation) in the real world. Unlike a typical clinical trial, this study watches how doctors normally prescribe these medications. It aims to understand how well the treatment works, patients' experiences using it, and its impact on their quality of life over two years. Participants will share information through a smartphone app, and their medical records will also be used. This helps us learn about the treatment in a broader range of patients than usually included in strict clinical trials.

At a glance

Status

Active not recruiting

Sponsor

Pierre Fabre Ltd

Enrolment target

Start

31 Jul 2025

Estimated completion

13 Jan 2028

Metastatic Melanoma, BRAF V600 Mutation Positive

What is this study about?

This study, called the UK ENcorafenib and BInimetinib Real-world Study in Melanoma, is designed to learn more about a specific treatment for advanced skin cancer called melanoma. This treatment uses two medicines, encorafenib and binimetinib. It's for people whose melanoma has spread (metastatic) and has a particular genetic change called a BRAF V600 mutation. This genetic change is found in some melanomas and means they might respond to these targeted therapies.

Unlike traditional clinical trials where specific doctors and nurses closely monitor participants, this study observes how these medications are used in everyday NHS care across the UK. We want to see how they perform in a wider group of patients, what challenges people might face, and how the treatment affects their daily lives and overall well-being. This kind of 'real-world' information is very valuable because it can capture experiences that might not be seen in highly controlled clinical trials.

The information gathered will help us understand the treatment's impact on quality of life and give us a clearer picture of its effectiveness and safety outside of a research setting. This study builds on earlier research, called the COLUMBUS trial, which initially showed that encorafenib and binimetinib are effective and safe. Now, we want to add to that knowledge with experiences from people receiving this treatment as part of their routine care.

Key takeaways

A UK study looking at melanoma treatment in everyday NHS care.
Focuses on encorafenib and binimetinib for advanced, BRAF V600-mutated melanoma.
Gathers information through a smartphone app and medical records.
Aims to understand treatment effectiveness and impact on quality of life.
No extra hospital visits or medical procedures are required.
Your participation helps improve care for future patients.

Who may be eligible?

To join this study, you need to be at least 18 years old and willing to provide your consent to participate. You must also have access to a smartphone, as this will be used for sharing information.

Crucially, you must have advanced skin cancer (melanoma) that has spread to other parts of your body, and your cancer cells must have a specific genetic change called a BRAF V600 mutation. You also need to be starting treatment with encorafenib and binimetinib as a second-line treatment, meaning it's not the first treatment you're trying for your advanced melanoma.

You would not be able to join if you are already taking other treatments for different types of cancer or if you are currently participating in another clinical trial.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have advanced melanoma with a BRAF V600 gene change?
Are you about to start encorafenib and binimetinib as your second treatment?
Do you have access to and feel comfortable using a smartphone?
Are you NOT in another clinical trial for cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be asked to provide information for 24 months (two years). You'll download a special smartphone app called Vitaccess Real™. Through this app, you'll regularly answer questions about your health and experiences with the treatment. This is known as 'patient-reported outcomes'.

Additionally, the study team at your hospital will look at your existing medical records to collect information about your treatment and health. All your information will be handled confidentially. There are no extra hospital visits required for this study; all data collection is done through the app and by reviewing your existing medical notes.

Potential risks and benefits

Participating in this study might not offer direct medical benefits to you personally, but the information you provide will be incredibly valuable to help doctors and researchers better understand this treatment and improve care for future melanoma patients. There are no additional medical risks as you would be receiving this treatment as part of your standard care. The main commitment is the time taken to complete questionnaires on your smartphone. You are free to withdraw from the study at any time without affecting your medical care.

Locations (7)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Southend University Hospital
Verified postcode
Westcliff-on-Sea, United Kingdom
Queen Elizabeth Hospital
Verified postcode
Birmingham, United Kingdom
Addenbrookes Hospital
Verified postcode
Cambridge, United Kingdom
University Hospital Coventry and Warwickshire
Verified postcode
Coventry, United Kingdom
Royal Marsden Hospital
Verified postcode
London, United Kingdom
Royal Preston Hospital
Verified postcode
Preston, United Kingdom
Southampton General Hospital
Verified postcode
Southampton, United Kingdom

Common questions

What is 'real-world' data?

Real-world data is information collected from patients as they receive treatment in their everyday lives, outside of tightly controlled clinical trials.

Why is this study important?

It helps us understand how this melanoma treatment works for a wider range of patients in normal NHS settings and how it affects their quality of life.

Do I need to visit the hospital more often if I join?

No, there are no extra hospital visits for this study. All your participation is through a smartphone app and review of your existing medical records.

Will my information be kept private?

Yes, all your personal and medical information will be handled confidentially and used only for research purposes, as outlined in the consent form.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, for any reason, without it affecting your medical care or relationship with your doctor.