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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.

Överblick

Status
Aktiv men inte rekryterande
Sponsor
Pierre Fabre Ltd
Inskrivningsmål
50
Starta
31 jul 2025
Beräknad slutförande
13 Jan 2028
Metastatic Melanoma, BRAF V600 Mutation Positive

Vad handlar denna studie om?

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.

Viktiga punkter

  • 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.

Vem kan vara berättigad?

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.

Kan denna studie passa dig?

Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.

  1. Är du 18 år eller äldre?
  2. Do you have advanced melanoma with a BRAF V600 gene change?
  3. Are you about to start encorafenib and binimetinib as your second treatment?
  4. Do you have access to and feel comfortable using a smartphone?
  5. Are you NOT in another clinical trial for cancer?
Svara på varje fråga för att se ditt resultat.

Vad innebär deltagande?

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.

Potentiella risker och fördelar

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.

Platser (7)

  • Southend University Hospital
    Verifierat postnummer
    Westcliff-on-Sea, United Kingdom
  • Drottning Elizabeth Sjukhus
    Verifierat postnummer
    Birmingham, Storbritannien
  • Addenbrookes Hospital
    Verifierat postnummer
    Cambridge, Storbritannien
  • University Hospital Coventry and Warwickshire
    Verifierat postnummer
    Coventry, Storbritannien
  • Royal Marsden Sjukhus
    Verifierat postnummer
    London, Storbritannien
  • Royal Preston Hospital
    Verifierat postnummer
    Preston, Storbritannien
  • Southampton General Hospital
    Verifierat postnummer
    Southampton, Storbritannien

Vanliga frågor

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.

Varför är denna studie viktig?

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.

Kommer min information att hållas privat?

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

Kan jag lämna studien om jag ändrar mig?

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

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