RecruitingOBSERVATIONAL

Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment

This study, called BERING-MELANOMA, is observing people in Germany, Austria, and Switzerland who are receiving two medicines, encorafenib and binimetinib, for advanced melanoma. It focuses on patients whose melanoma has a specific change called a BRAF V600 mutation, and it's for melanoma that cannot be removed by surgery (unresectable advanced or metastatic). Researchers are interested in seeing how effective these treatments are in real-life use, how they affect patients' quality of life, and what side effects might occur. This is not a traditional trial where researchers decide your treatment; instead, it looks at how these medicines are used in regular care, either as a first treatment or after one previous treatment called checkpoint inhibition.

At a glance

Status

Recruiting

Sponsor

Pierre Fabre Pharma GmbH

Enrolment target

750

Start

17 Oct 2019

Estimated completion

01 Sep 2027

Melanoma Stage IV Melanoma Stage III

What is this study about?

Imagine you or someone you know has advanced melanoma, a type of skin cancer that has spread. This study focuses on a specific kind of advanced melanoma where the cancer cells have a particular change, or 'mutation', called BRAF V600. When cancer has this mutation, certain medicines can be very effective at targeting it.

This study, called BERING-MELANOMA, is looking at two such medicines, encorafenib and binimetinib, when they are used together. It's not a typical clinical trial where people get new, experimental drugs. Instead, it's observing how these two approved medicines work in everyday healthcare settings. The goal is to understand their real-life effectiveness, how they impact patients' quality of life, and to track any side effects people might experience.

Researchers are collecting information from patients in Germany, Austria, and Switzerland who are already being treated with these medications by their doctors. This helps them get a complete picture of how the combination therapy behaves when used in the general patient population, allowing them to better understand how it benefits people with advanced melanoma.

Key takeaways

This study looks at approved melanoma medicines in everyday treatment.
It's for advanced melanoma with a specific gene change (BRAF V600 mutation).
It helps us understand real-world effectiveness and side effects.
Participation involves sharing medical information from your standard care.
You won't receive different treatment by joining.

Who may be eligible?

To be part of this study, you need to be an adult (18 years or older) with advanced melanoma that can't be removed with surgery. Your melanoma must also have a specific gene change called a BRAF V600 mutation. Your doctor must have already decided to treat you with the combination of encorafenib and binimetinib, either recently or in the near future, based on standard medical guidelines. This means your treatment decision happens independently of whether you join the study.

You might be eligible if you haven't had any treatment for your advanced melanoma before, or if you've only had one previous treatment with a type of medicine called a checkpoint inhibitor (like anti-CTLA4 or anti-PD(L)1). You won't be able to join if you've had certain other previous melanoma treatments, like specific BRAF or MEK inhibitor drugs (unless it was for a short while after surgery more than 6 months ago) or more than one type of checkpoint inhibitor in the advanced setting. You also can't be taking part in another clinical trial at the same time, or be receiving treatment for another type of cancer.

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 that can't be surgically removed?
Does your melanoma have a BRAF V600 mutation?
Has your doctor decided you will be treated with encorafenib plus binimetinib?
Have you had no prior treatment, or only one previous checkpoint inhibitor for advanced melanoma?

Answer every question to see your result.

What does participation involve?

This study isn't about giving you new medicine; it's about watching how the encorafenib and binimetinib you'd already be taking are working. If you're eligible and agree to join, the main thing you'll be doing is letting the study team collect information from your regular doctor visits and medical records. This will include details about your melanoma, the treatment you're receiving, how you're feeling, and any side effects. You won't have extra visits just for the study, and you won't be asked to do anything different from your usual medical care. The study team will gather this information over time to see how the treatment works in the long run.

Potential risks and benefits

The main benefit of taking part in this study is helping doctors and researchers learn more about how encorafenib and binimetinib work in real-world settings. This information can help improve care for future patients with melanoma. Because you'll be receiving approved medicines as part of your standard care, there are no additional medical risks from the study itself beyond the known risks and side effects of the medicines prescribed by your doctor. Your personal information will be kept private, using codes instead of your name. Remember, joining is completely voluntary, and you can change your mind and withdraw from the study at any time without it affecting your medical care.

Locations (59)

11
Verified postcode
Graz, Austria· Recruiting
13
Verified postcode
Innsbruck, Austria· Recruiting
14
Verified postcode
Klagenfurt, Austria· Recruiting
10
Verified postcode
Linz, Austria· Recruiting
3
Verified postcode
Linz, Austria· Recruiting
12
Verified postcode
Salzburg, Austria· Recruiting
22
Verified postcode
Vienna, Austria· Recruiting
53
Verified postcode
Vienna, Austria· Recruiting
23
Verified postcode
Wiener Neustadt, Austria· Recruiting
45
Verified postcode
Ahaus, Germany· Recruiting
8
Verified postcode
Aschaffenburg, Germany· Recruiting
56
Verified postcode
Augsburg, Germany· Recruiting

Common questions

What kind of cancer is this study for?

It's for advanced melanoma, which is a serious type of skin cancer that has spread.

What are encorafenib and binimetinib?

They are two medicines used together to treat a specific type of advanced melanoma that has a gene change called a BRAF V600 mutation.

Will I get new treatment if I join this study?

No, this study observes patients who are already receiving encorafenib and binimetinib as part of their standard medical care. You won't receive extra or different treatments for joining.

How will my personal information be kept private?

Your information will be anonymised or coded, meaning your name won't be directly linked to the data collected for the study.

Can I leave the study at any time?

Yes, taking part is completely voluntary, and you can decide to stop participating at any point without it affecting your medical treatment.

How to find out more

Christian A Rosé, MD

bering_de@pierre-fabre.com +49 761 45261 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.