Study of local treatment options for large metastases in patients with BRAF V600 mutated melanoma receiving Encorafenib and Binimetinib combination therapy

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What is this study about?

This study focuses on patients with melanoma that has a specific genetic change called BRAF V600 mutation. The melanoma must be either inoperable (cannot be removed by surgery) or has spread to other parts of the body. The study will test a combination of two medications: encorafenib and binimetinib, which are drugs that target specific proteins involved in cancer growth.

The purpose of this study is to determine how well patients respond to local treatments (such as radiotherapy, surgery, or electrochemotherapy) when they are already receiving encorafenib and binimetinib. These local treatments will be used on specific tumor sites while patients continue taking their regular medication.

During the study, patients will receive encorafenib and binimetinib as oral medications daily. When certain tumors remain stable or continue to grow while other tumors are responding to treatment, doctors may use local treatments like radiotherapy, surgery, or electrochemotherapy to target these specific areas. Patients will be monitored regularly to check how their cancer responds to this combination of treatments and to watch for any side effects.

1 Initial treatment phase

You will receive two medications taken by mouth: encorafenib and binimetinib

This treatment must continue for at least 3 months before proceeding to the next phase

During this time, your medical team will monitor how your disease responds to the treatment

2 Evaluation period

You will undergo imaging tests (CT or MRI) of your chest, abdomen, pelvis, and head

These tests must be completed within 28 days before the next treatment phase

The medical team will assess how your tumors are responding to the medication

3 Local treatment

Based on your specific situation, you will receive one of these treatments for selected tumors:

– Surgery to remove the tumor

– Radiation therapy

– Electrochemotherapy (a treatment that combines chemotherapy with electrical pulses)

This treatment will focus on 1 to 3 specific tumor sites while continuing the oral medications

4 Follow-up monitoring

Regular check-ups will track your progress and any side effects

You will complete quality of life questionnaires

Imaging tests will be performed to monitor how your disease responds to the treatment

Blood tests will be conducted to ensure proper organ function

5 Ongoing medication

You will continue taking encorafenib and binimetinib as prescribed

The treatment will continue as long as it remains beneficial and tolerable

Regular monitoring of heart function will be performed, including tests to measure heart pumping ability

Blood tests will continue to ensure the treatment remains safe

Who Can Join the Study?

Must be at least 18 years old
Must have signed an informed consent form
Must have melanoma that cannot be operated on (inoperable stage III) or has spread to other parts of the body (metastatic stage IV)
Must have a confirmed BRAF V600 mutation (a specific genetic change in the tumor)
Must have been receiving treatment with Encorafenib plus Binimetinib for at least 3 months
Must have measurable tumors that can be seen on scans
Must have recent imaging scans (CT or MRI) of chest, abdomen, pelvis, and head within the last 28 days
Must have good overall physical function (ECOG status 0-2, meaning able to perform most daily activities)
Must have a life expectancy of at least 12 weeks
Must have adequate blood test results showing:
- Good bone marrow function
- Normal kidney function
- Normal liver function
Must have good heart function with:
- Heart pumping strength of at least 50%
- Normal heart rhythm measurements
For women who can become pregnant: must have a negative pregnancy test and use effective birth control
Must have recovered from any previous treatment side effects

Who Cannot Join the Study?

History of severe allergic reactions to any BRAF inhibitors (drugs that target specific proteins in melanoma cells)
Presence of active brain metastases (cancer that has spread to the brain) that are not stable or require increasing doses of steroids
Previous participation in a clinical trial within the last 30 days
Pregnant or breastfeeding women
Serious heart conditions, including:
- Unstable angina (chest pain)
- Recent heart attack within 6 months
- Severe heart rhythm problems
Active or untreated infections that require systemic therapy (medication that affects the entire body)
Other active cancers requiring treatment (except for adequately treated non-melanoma skin cancer or cervical cancer in situ)
Severe liver or kidney problems that could affect the metabolism of study medications
Any condition that, in the opinion of the study doctor, would make participation unsafe
Unable to understand or provide informed consent

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
SRH Wald-Klinikum Gera GmbH	Gera	Germany
HELIOS Kliniken Schwerin GmbH	Schwerin	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Deutsches Rotes Kreuz Gemeinnuetzige Krankenhaus GmbH Sachsen	Chemnitz	Germany
Klinikum Kassel GmbH	Kassel	Germany
Uxvvikbljp Mnxxiih Cxjraj Hbwkgqccuuhyksgto	Hamburg	Germany
Mcgzrqmheijifvngkimzioggxg Hwqodgittatgjtcy	Halle (Saale)	Germany
Gjlbiu Uljoubzahg Flkskhgwg	Frankfurt	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	30.03.2025

Trial locations

Investigated drugs:

Encorafenib is a targeted therapy medication used to treat melanoma (skin cancer) that has a specific genetic mutation called BRAF V600. It works by blocking the abnormal BRAF protein that helps cancer cells grow.

Binimetinib is also a targeted therapy medication that works together with Encorafenib. It blocks a different protein called MEK, which is also involved in cancer cell growth. When used together with Encorafenib, it helps to more effectively stop or slow down the growth of melanoma cells.

Radiotherapy is a treatment that uses high-energy radiation beams to target and destroy cancer cells, specifically used in this trial to treat large metastases (areas where cancer has spread).

Surgery involves the physical removal of metastatic tumors by surgical procedures.

Electrochemotherapy is a treatment that combines chemotherapy with electrical pulses to help the anti-cancer drugs enter cancer cells more effectively, making the treatment more powerful against metastases.

Investigated diseases:

Melanoma – A type of skin cancer that develops from melanocytes, the cells that produce melanin pigment. It begins when normal melanocytes become transformed into cancer cells and grow uncontrollably, often starting as a new spot on the skin or from an existing mole that changes in appearance. In its advanced stages (unresectable or metastatic), the cancer cannot be completely removed by surgery or has spread to other parts of the body. When melanoma has a BRAF V600 mutation, it means the cancer cells have a specific change in their DNA that affects how they grow and divide. This form of melanoma can progress more aggressively than other types, spreading beyond its original location to other organs and tissues.

Trial ID:

2024-516073-74-00

Protocol code:

WKG 139175-52

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of local treatment options for large metastases in patients with BRAF V600 mutated melanoma receiving Encorafenib and Binimetinib combination therapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?