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

3 1 1 1

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

Other Sites

Site Name City Country Status
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
Ukvdorogmy Mgciznt Cyzlxg Hcximjzkskuxpfdgd Hamburg Germany
Mpynonwrymenioodxslaooiqan Hgvaeonmwrwecbtr Halle (Saale) Germany
Gbpwss Ukpuqagjub Fgdyvsdgc Frankfurt Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany 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.

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)

Other Trials to Consider

  • Long-term Safety Study of Vusolimogene Oderparepvec, RP2, and RP3 in Patients with Melanoma, Liver Cancer, or Advanced Solid Tumors

    Recruiting

    3 1 1
    France Germany Greece Poland Spain
  • Study Comparing Ipilimumab and Nivolumab to Nivolumab Alone for Patients with Resectable Stage III Melanoma

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Sweden