Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

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

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

16 criteria

  • 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 trial?

12 criteria

  • 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
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

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.

What is already known about the treatment

  • Encorafenib

    An oral targeted therapy medication used in the treatment of advanced melanoma with BRAF V600 mutation. It works by blocking the abnormal BRAF protein that drives cancer growth, specifically targeting the V600 mutation in melanoma cells. This medication belongs to the class of kinase inhibitors and is typically administered in combination with Binimetinib for better treatment outcomes in patients with unresectable or metastatic melanoma.

  • Binimetinib

    An oral medication that belongs to the MEK inhibitor class, used in combination with Encorafenib for treating advanced melanoma with BRAF V600 mutation. It works by blocking the MEK protein in the MAP kinase pathway, which is involved in cancer cell growth and survival. This targeted therapy helps prevent cancer progression and is specifically designed for patients with unresectable (inoperable) or metastatic melanoma who have tested positive for the BRAF V600 mutation.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516073-74-00Protocol codeWKG 139175-52Estimated enrolment101 patientsSponsorSRH Wald-Klinikum Gera GmbH

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.