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Study on Encorafenib, Binimetinib, Cemiplimab, and Fianlimab for Patients with BRAF-Mutated Melanoma and Brain Metastases

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What is this trial about?

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

This clinical trial is focused on studying a type of skin cancer called melanoma, specifically in patients who have a mutation known as BRAF and have cancer that has spread to the brain, causing symptoms. The study will use a combination of medications to see how effective they are in treating this condition. The medications involved are Encorafenib and Binimetinib, which are taken orally, followed by Cemiplimab and Fianlimab, which are given through an injection into a vein.

The purpose of the study is to evaluate how well these medications work together in preventing the cancer from getting worse in the brain over a period of six months. Participants will first receive Encorafenib and Binimetinib for a set period, and then switch to receiving Cemiplimab and Fianlimab. The study will monitor the participants' health and the progression of their cancer during this time.

Throughout the study, participants will have regular check-ups and tests to track their response to the treatment. The study aims to provide valuable information on the effectiveness of this treatment combination for patients with BRAF-mutated melanoma and brain metastases, which are cancer cells that have spread to the brain. The results could help improve future treatment options for this condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Beginning of treatment

    Upon joining the clinical trial, the patient will begin treatment with two medications: encorafenib and binimetinib. These medications are taken orally. Encorafenib is available in two forms: 75 mg and 50 mg hard capsules. Binimetinib is provided as 15 mg film-coated tablets.

    The patient will take these medications daily. The specific dosage and frequency will be determined by the healthcare provider based on individual needs and conditions.

  2. Step 2

    Transition to new treatment

    After the initial phase with encorafenib and binimetinib, the patient will transition to a new treatment phase involving cemiplimab and fianlimab.

    Cemiplimab is administered as a 350 mg concentrate for solution, given through an intravenous infusion. Fianlimab is also administered intravenously as a solution for injection.

    The frequency and duration of these treatments will be specified by the healthcare provider, ensuring they align with the trial's protocol.

  3. Step 3

    Monitoring and assessments

    Throughout the trial, the patient will undergo regular monitoring and assessments to evaluate the effectiveness of the treatment and to check for any side effects.

    These assessments may include physical examinations, laboratory tests, and imaging studies such as MRI to monitor brain metastases.

    The healthcare team will assess the patient's health status and adjust the treatment plan as necessary.

  4. Step 4

    End of trial participation

    At the end of the trial, the patient's participation will conclude. The healthcare team will conduct a final assessment to evaluate the overall outcomes of the treatment.

    The patient will receive guidance on any further steps or follow-up care needed after the trial.

Who can join the trial?

17 criteria

  • Provide written informed consent, which means you agree to participate after understanding the study details.
  • Have adequate liver function, which means your liver is working well enough based on specific blood tests.
  • Have a serum creatinine level that is not too high, indicating your kidneys are functioning properly.
  • Previous immunotherapy is allowed if any severe side effects have resolved.
  • Use of steroids or anticonvulsants is allowed if needed, as long as the dose hasn't increased in the last 5 days before starting the study treatment.
  • If you are a woman who can have children, you must have a negative pregnancy test and agree to use effective birth control during the study and for 6 months after.
  • If you are a man with a partner who can have children, you must use condoms during the study and for 6 months after, unless you have had a vasectomy or practice abstinence.
  • Women must agree not to donate eggs, and men must agree not to donate sperm during the study and for 6 months after.
  • Be willing and able to attend scheduled visits and follow the study procedures.
  • Have a confirmed diagnosis of **unresectable metastatic BRAF-mutated melanoma** with brain metastases, which means the cancer has spread to the brain and cannot be removed by surgery.
  • Have brain metastases that cause symptoms, such as headaches or seizures, even if controlled with medication.
  • Have a documented **BRAFV600 mutation** in the tumor tissue, which is a specific change in the cancer cells.
  • Have a **Modified Barthel Index** score of more than 10, which measures your ability to perform daily activities.
  • Be at least 18 years old.
  • Have a performance status of **ECOG PS 0-2**, which means you are fully active or have some limitations but can still care for yourself.
  • Be able to swallow.
  • Have adequate blood cell counts, which means your blood tests show enough red blood cells, white blood cells, and platelets.

Who cannot join the trial?

5 criteria

  • Patients who do not have a specific type of skin cancer called BRAF-mutated melanoma cannot participate.
  • Patients who do not have symptomatic brain metastases (cancer that has spread to the brain and is causing symptoms) are not eligible.
  • Patients who are not within the specified age range for the study cannot join. The study is open to certain age groups only.
  • Both male and female patients are eligible, but those who do not meet other criteria will be excluded.
  • Patients who are considered part of a vulnerable population may not be eligible. This includes groups who may need special protection or care.
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Investigated drugs

  • Encorafenib

    is a medication used to treat certain types of cancer, specifically melanoma that has a mutation in the BRAF gene. It works by blocking the activity of the BRAF protein, which is involved in the growth and spread of cancer cells. By inhibiting this protein, encorafenib can help slow down or stop the growth of cancer cells.

  • Binimetinib

    is another medication used in combination with encorafenib to treat melanoma with a BRAF mutation. It targets a different protein in the cancer cell growth pathway, known as MEK. By blocking MEK, binimetinib helps to further inhibit the growth and spread of cancer cells, enhancing the effect of encorafenib.

  • Cemiplimab

    is an immunotherapy drug that helps the body's immune system fight cancer. It works by blocking a protein called PD-1 on the surface of immune cells. This action allows the immune cells to better recognize and attack cancer cells, helping to control the disease.

  • Fianlimab

    is another immunotherapy medication used in combination with cemiplimab. It targets a different protein involved in regulating the immune system's response to cancer. By working together, fianlimab and cemiplimab can enhance the immune system's ability to detect and destroy cancer cells, offering a potential treatment option for patients with melanoma.

What is already known about the treatment

  • Encorafenib

    Encorafenib is administered orally in the form of a tablet. It is currently being studied in clinical trials for its effectiveness in treating melanoma, particularly in patients with BRAF-mutated melanoma and brain metastases. The main therapeutic indication is for melanoma with specific genetic mutations. At the molecular level, encorafenib works by inhibiting a protein called BRAF, which is involved in cell growth, thereby slowing down or stopping the growth of cancer cells. It is classified as a BRAF inhibitor in pharmacology.

  • Binimetinib

    Binimetinib is taken orally as a tablet and is being evaluated in clinical trials for its role in treating melanoma, especially in cases with BRAF mutations and brain metastases. It is primarily indicated for melanoma with certain genetic changes. Binimetinib acts by inhibiting a protein called MEK, which is part of a pathway that helps cancer cells grow, thus helping to control the spread of the cancer. It belongs to the class of drugs known as MEK inhibitors.

  • Cemiplimab

    Cemiplimab is administered through an intravenous infusion. It is under investigation in clinical trials for its potential to treat melanoma, particularly in patients with BRAF mutations and brain metastases. The main therapeutic use is for melanoma. Cemiplimab works by blocking a protein called PD-1, which helps the immune system recognize and attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor.

  • Fianlimab

    Fianlimab is given via intravenous infusion and is being studied in clinical trials for its effectiveness in treating melanoma, especially in patients with BRAF mutations and brain metastases. Its primary therapeutic indication is for melanoma. Fianlimab functions by targeting and inhibiting specific proteins that can suppress the immune system, thereby enhancing the body's ability to fight cancer. It is part of the class of drugs known as immune checkpoint inhibitors.

Investigated diseases

Melanoma – Melanoma is a type of skin cancer that originates in the melanocytes, the cells responsible for producing melanin, the pigment that gives skin its color. It often begins as a mole that changes in size, shape, or color, but it can also develop on skin that appears normal. As melanoma progresses, it can invade deeper layers of the skin and spread to other parts of the body, including the lymph nodes, liver, lungs, and brain. The disease is known for its ability to metastasize, or spread, rapidly if not detected early. Melanoma can also cause symptoms such as changes in skin texture, itching, or bleeding. Early detection and monitoring of skin changes are crucial in managing the progression of melanoma.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513375-40-00Protocol codeGEM 2301Estimated enrolment33 patientsSponsorGrupo Espanol Multidisciplinar De Melanoma

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