Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Surgical or radiotherapeutic intervention concerning large singular stable to progressive metastases in patients with BRAFV600-mutated melanoma receiving treatment with Encorafenib + Binimetinib

This research study is for people who have advanced melanoma, a type of skin cancer that has spread, and have a specific gene change (called a BRAF V600 mutation). These patients are already being treated with two medications, Encorafenib and Binimetinib, which are known to help. The study wants to find out if adding local treatments like surgery, radiotherapy (radiation therapy), or electrochemotherapy (using electricity to help chemotherapy) to their existing drug treatment can help them live longer without their cancer getting worse. Researchers will track how long people stay well, how their cancer responds, and how they feel during the study to learn more about the best ways to treat this type of melanoma.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

SRH Wald-Klinikum Gera GmbH

Enrolment target

101

Start

23 Jan 2025

Unresectable or metastatic melanoma with a BRAF V600 mutation (inoperable stage III or metastatic stage IV)

What is this study about?

This research study is about finding the best combination of treatments for people with a type of advanced skin cancer called melanoma. Specifically, it's for those whose melanoma has spread or is inoperable, meaning surgery isn't possible, and it has a particular genetic change known as a BRAF V600 mutation. If you have this type of melanoma, you are likely already taking two medicines, Encorafenib and Binimetinib, which are designed to target this specific cancer.

The main goal of this study is to see how much improvement people experience when they also get a 'local' treatment for large, stable, or slowly growing tumours. Local treatments mean they target a specific part of the body, such as surgery (removing the tumour), radiotherapy (using radiation to kill cancer cells), or electrochemotherapy (using mild electric pulses to make chemotherapy drugs work better on the tumour). Researchers want to find out how long people live without their cancer getting worse after receiving one of these local treatments along with their ongoing medication.

Beyond simply tracking cancer growth, the study will also look at other important things. This includes how long people live overall, how well their tumours respond to treatment, and how their quality of life changes throughout the study. They will also carefully monitor any side effects or problems that might come up from the treatments. By studying all these factors, doctors hope to understand which combinations of treatments work best and help people with this challenging type of melanoma live better and longer.

Key takeaways

This study is for adults with advanced melanoma that has a BRAF V600 gene change.
Participants will already be taking Encorafenib and Binimetinib medications.
The study explores adding local treatments (like surgery or radiotherapy) to existing drug therapy.
It aims to see how long people live without their cancer growing and how treatments affect their well-being.
Researchers will also carefully monitor any side effects from the treatments.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

You must have advanced melanoma that has spread to other parts of your body, or is in a stage where surgery isn't an option. An important factor is that your melanoma must have a specific change in its genes, called a BRAF V600 mutation. This is something your doctors will have already tested for.

Also, a key part of this study is that you must already be receiving treatment with the two specific medicines, Encorafenib and Binimetinib, for your melanoma. The study focuses on situations where you might also need a 'local' treatment, like surgery or radiotherapy, for specific larger tumours that are either stable or slowly growing.

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 has spread or is inoperable?
Has your melanoma been tested and shown to have a BRAF V600 mutation?
Are you currently receiving treatment with Encorafenib and Binimetinib?
Do you have one or more large tumours that are stable or slowly growing that might need local treatment?

Answer every question to see your result.

What does participation involve?

If you decide to participate in this study, the doctors and nurses will monitor your health very closely. You will continue to take your prescribed medications, Encorafenib and Binimetinib. In addition, you may receive a 'local' treatment such as surgery, radiotherapy, or electrochemotherapy for specific tumours. The exact number of visits will depend on your chosen local treatment and monitoring schedule, but you can expect regular appointments for scans, blood tests, and check-ups to see how you are doing and how the treatment is affecting your cancer. You'll also be asked to fill out questionnaires about how you're feeling to help us understand your quality of life during the study. This study is considered 'Phase IV,' meaning it's looking at the effectiveness and safety of treatments that are already in use, so it will involve long-term follow-up to track your health and the progress of your cancer.

Potential risks and benefits

Participating in this study might offer potential benefits, as it could lead to better management of your melanoma by combining existing targeted drug therapy with local treatments, potentially helping to control certain tumours more effectively and possibly improving your length of life without cancer growth. However, like all medical treatments, there are potential risks, including side effects from the medications (Encorafenib and Binimetinib) and any local treatments (surgery, radiotherapy, electrochemotherapy). These side effects vary and your medical team will discuss them with you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Germany

Common questions

What is advanced melanoma?

Advanced melanoma means the cancer has spread to other parts of your body from where it started, or it's in a stage where surgery to remove it isn't possible.

What is a BRAF V600 mutation?

This is a specific change found in the genes of some melanoma cancer cells. Knowing about this change helps doctors choose the right medications, like Encorafenib and Binimetinib, which are designed to target it.

What are Encorafenib and Binimetinib?

These are two medicines that work together to treat melanoma with the BRAF V600 gene change. They are 'targeted therapies' because they specifically attack cancer cells with this mutation.

What does 'local treatment' mean in this study?

Local treatments focus on a specific part of your body. In this study, it refers to surgery, radiotherapy (radiation), or electrochemotherapy, which are used to treat particular tumours.

Why is 'quality of life' important to measure?

It's important because treatment should not only fight the cancer but also help you feel as well as possible. This study uses questionnaires to understand how the treatments affect your daily life and well-being.