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Study on Binimetinib, Encorafenib, and Pembrolizumab for Patients with BRAF V600 Mutation-Positive Melanoma and Brain Metastasis

Verified siteRegistered drugNo placebo

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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 that has spread to the brain. Specifically, it involves patients with a genetic change known as the BRAFV600 mutation. The study is testing a combination of three treatments: binimetinib, encorafenib, and pembrolizumab. Binimetinib is taken as a tablet, encorafenib is taken as a capsule, and pembrolizumab is given as an infusion into a vein. The trial aims to see if adding a special type of radiation treatment called stereotactic radiosurgery (SRS) to this combination of medications can help improve outcomes for patients.

Participants in the study will receive either the combination of binimetinib, encorafenib, and pembrolizumab alone or the same combination with the addition of SRS. The study will monitor how the cancer responds to these treatments and how long it takes for the cancer to progress in the brain. The trial will also look at the overall health and quality of life of the participants during the study period. The study is expected to continue until 2030, with participants being closely monitored throughout the trial.

The research process

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

Step 1
Initial treatment phase
The treatment begins with the administration of pembrolizumab through an intravenous infusion. This medication is provided as a solution for infusion, specifically KEYTRUDA 25 mg/mL.
Alongside pembrolizumab, two oral medications are taken: binimetinib and encorafenib. Binimetinib is available as Mektovi 15 mg film-coated tablets, and encorafenib is available as Braftovi 75 mg hard capsules.
Step 2
Medication schedule
Pembrolizumab is administered every three weeks through an intravenous infusion.
Binimetinib is taken orally twice a day, with or without food.
Encorafenib is taken orally once a day, with or without food.
Step 3
Monitoring and assessments
Regular monitoring is conducted to assess the response to treatment. This includes imaging tests such as MRI to evaluate the status of brain metastases.
Health-related quality of life is assessed using specific questionnaires, and cognitive performance is evaluated using the Montreal Cognitive Assessment.
Step 4
Follow-up phase
After completing the treatment, follow-up visits are scheduled to monitor the patient's health and any potential long-term effects of the treatment.
The duration of the follow-up phase is determined based on individual response and overall health status.

Who can join the trial?

17 criteria

Provide written informed consent before any trial-specific procedures.
Have at least one measurable lesion in the brain.
All previous cancer treatment side effects (except hair loss and lab values) must be resolved or be mild according to a specific grading system.
Be able to swallow and keep oral medication and not have significant stomach or bowel issues that affect absorption.
Have adequate bone marrow, organ function, and lab test results.
Have adequate heart function.
Women who can have children or men must agree to avoid sexual activity or use effective birth control during the study and for 120 days after treatment. Men must also agree not to donate sperm during this time.
Be affiliated with or a beneficiary of the local social security system or equivalent.
Be willing and able to follow the study protocol, including treatment, visits, exams, and follow-up.
Be at least 18 years old.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, which means being fully active or having some symptoms but being able to carry out light work.
Have Stage IV M1d cutaneous melanoma or unknown primary melanoma that has spread to the brain, confirmed by a tissue test. Patients with mucosal melanomas are not eligible.
Have a specific mutation called **BRAFV600E/K/D/R** confirmed by a local test.
Be a candidate for **SRS therapy**, confirmed by a radiation oncologist and neurosurgeon, and documented in the patient file.
Have not received previous combined systemic treatment for melanoma that has spread to distant parts of the body.
Have had no more than one previous local brain treatment for one lesion, such as surgery or **SRS**.
Be able to undergo a special type of brain scan called **gadolinium-enhanced MRI**.

Who cannot join the trial?

6 criteria

Patients who do not have a **BRAF(V600) mutation-positive melanoma**. This means the specific type of skin cancer with a certain genetic change.
Patients without **brain metastasis**. This refers to cancer that has spread to the brain.
Patients who are not within the specified age range for the study.
Patients who are not able to receive the combination therapy of **binimetinib**, **encorafenib**, and **pembrolizumab**. These are specific medications used in the treatment.
Patients who are unable to undergo **SRS** (Stereotactic Radiosurgery). This is a type of radiation therapy that targets tumors in the brain.
Patients who are considered part of a vulnerable population that the study cannot safely include.

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Verified sites

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

Verified
Assistance Publique Hopitaux De Marseille
Marseille, France
Verified
Centre Francois Baclesse
Caen, France
Verified
Centre Hospitalier Universitaire De Bordeaux
Bordeaux, France

Trial locations

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Investigated drugs

Binimetinib
is a medication used to treat certain types of cancer by blocking specific proteins that promote cancer cell growth. In this trial, it is part of a combination therapy aimed at treating melanoma with brain metastasis.
Encorafenib
is another cancer treatment that targets proteins involved in the growth and spread of cancer cells. It is used alongside other medications to enhance the effectiveness of the treatment for melanoma with brain metastasis.
Pembrolizumab
is an immunotherapy drug that helps the immune system recognize and attack cancer cells. It is included in the combination therapy to improve the body's natural defenses against melanoma with brain metastasis.
Stereotactic Radiosurgery (SRS)
is a non-invasive radiation therapy that precisely targets brain tumors. In this trial, it is being tested to see if adding it to the combination of binimetinib, encorafenib, and pembrolizumab improves outcomes for patients with melanoma that has spread to the brain.

What is already known about the treatment

Binimetinib
This medication is taken orally and is currently being studied in clinical trials for its effectiveness in treating melanoma with specific genetic mutations. It is primarily used for patients with BRAF(V600) mutation-positive melanoma, particularly those with brain metastasis. Binimetinib works by inhibiting certain proteins in the cancer cells, which helps to slow down or stop their growth. It belongs to a class of drugs known as MEK inhibitors.
Encorafenib
Administered orally, encorafenib is under investigation in clinical trials for its role in treating melanoma with specific genetic mutations. It is used for patients with BRAF(V600) mutation-positive melanoma, especially those with brain metastasis. Encorafenib functions by blocking the activity of a protein that promotes cancer cell growth, thereby helping to control the spread of the disease. It is classified as a BRAF inhibitor.
Pembrolizumab
This medication is given through intravenous infusion and is being evaluated in clinical trials for its potential benefits in treating melanoma with certain genetic mutations. It is indicated for patients with BRAF(V600) mutation-positive melanoma with brain metastasis. Pembrolizumab works by enhancing the immune system's ability to detect and fight cancer cells. It is part of a group of drugs known as immune checkpoint inhibitors.

Investigated diseases

Melanoma with Brain Metastasis – This is a type of skin cancer that has spread to the brain. It originates from melanocytes, the cells responsible for skin pigmentation. When melanoma cells travel through the bloodstream or lymphatic system, they can form secondary tumors in the brain. The presence of brain metastases can lead to neurological symptoms such as headaches, seizures, or cognitive changes. The progression of the disease involves the growth and spread of these metastatic tumors within the brain. The BRAF(V600) mutation is a specific genetic change that can drive the growth of melanoma cells, making it a target for certain therapies.