In short
There are currently 2 ongoing clinical trials studying treatments for central nervous system melanoma, focusing on patients with specific BRAF V600E/K genetic mutations. These trials are testing combinations of targeted therapies and immunotherapy drugs across multiple European countries including Germany, Spain, Italy, Poland, and Slovakia.
Clinical trial locations
- Belgium
- Bulgaria
- Czechia
- Finland
- Germany
- Greece
- Hungary
- Italy
- Poland
- Slovakia
- Spain
Study of Encorafenib, Binimetinib, and Pembrolizumab for Patients with Advanced Melanoma with BRAF V600E/K Mutation
This trial is testing a combination of three medications for patients with melanoma that has spread to other parts of the body or cannot be removed by surgery. The study specifically focuses on patients whose cancer cells have a genetic change known as the BRAF V600E/K mutation. This mutation causes cancer cells to grow uncontrollably, making the disease more aggressive.
Main inclusion criteria: Participants must be at least 18 years old and have melanoma that is either not removable by surgery or has spread to other parts of the body, confirmed through laboratory testing. The cancer must have the BRAF V600E or V600K mutation, and tumor tissue must be provided for testing. For the safety phase, patients should not have received more than one previous treatment, while for the main phase, patients should have no previous treatment for advanced disease. Participants must have at least one tumor that can be measured and must be in good general health with healthy organ and heart function.
Main exclusion criteria: Patients with other types of cancer, recent cancer treatments, serious heart, liver, or kidney problems are not eligible. Pregnant or breastfeeding women, patients with uncontrolled infections, those with other serious illnesses, or those unable to follow study procedures are also excluded.
Focus and goal: The trial aims to compare the effectiveness of the three-drug combination of encorafenib, binimetinib, and pembrolizumab against a control treatment with placebo and pembrolizumab. The study will run for up to 24 months, during which participants receive regular treatments and monitoring. The goal is to determine if the combination therapy can improve outcomes for patients with this specific type of melanoma while assessing the safety of the treatment.
Investigational drugs: Encorafenib is taken as a capsule and blocks a protein that promotes cancer cell growth. Binimetinib is taken as a tablet and targets a different protein in the cancer growth pathway to enhance the effects of encorafenib. Pembrolizumab is given through an infusion into a vein and is an immunotherapy drug that helps the immune system recognize and attack cancer cells by blocking a protein that prevents immune response.
Study of Encorafenib, Binimetinib, and Pembrolizumab for Patients with BRAF V600E/K Mutation-Positive Melanoma After Anti-PD-1 Therapy
This trial is designed for patients with melanoma that has continued to grow despite previous treatment with anti-PD-1 therapy, a type of immunotherapy. The study targets patients whose cancer has the BRAF V600E/K mutation and whose disease has either spread or cannot be surgically removed.
Main inclusion criteria: Participants must be at least 18 years old with melanoma confirmed by testing. The cancer must have the BRAF V600E or V600K mutation, and a tumor sample must be provided for laboratory testing. Patients must have received only one previous treatment, either after surgery or as first-line anti-PD-1 therapy such as nivolumab or pembrolizumab. The melanoma must be resistant to anti-PD-1 treatment, meaning it did not respond or stopped responding to this therapy. Participants must have at least one measurable tumor and be in good general health with healthy organ and heart function.
Main exclusion criteria: Similar to the first trial, patients with other types of cancer, recent treatments, serious health problems affecting the heart, liver, or kidneys, pregnant or breastfeeding women, and those with uncontrolled infections or inability to follow procedures are excluded.
Focus and goal: The trial compares two treatment combinations: one group receives encorafenib, binimetinib, and pembrolizumab, while the other receives nivolumab and ipilimumab. Both are immunotherapy approaches, but they work through different mechanisms. The study aims to determine which combination is more effective in controlling cancer growth and improving patient health. Regular monitoring includes imaging tests to evaluate tumor size and blood tests to check for side effects. The trial is estimated to conclude by May 2027.
Investigational drugs: Encorafenib and binimetinib work the same way as described in the first trial, targeting specific proteins involved in cancer cell growth. Pembrolizumab blocks the PD-1 pathway to boost immune response. Nivolumab is another immunotherapy drug given through infusion that also targets the PD-1 protein on immune cells. Ipilimumab is given through infusion and works by targeting the CTLA-4 protein on immune cells, activating the immune system to attack cancer cells through a different pathway.
Summary
Both ongoing clinical trials for central nervous system melanoma focus on patients with the BRAF V600E/K mutation, a specific genetic change that makes the cancer more aggressive. The trials are being conducted across multiple European countries, with Germany, Spain, Italy, Poland, and Slovakia hosting both studies.
A notable pattern is the focus on combination therapies that include both targeted drugs and immunotherapy. The first trial is for patients who have not yet received extensive treatment, while the second trial specifically targets patients whose cancer has continued to grow after anti-PD-1 therapy. Both trials test encorafenib, binimetinib, and pembrolizumab, highlighting the medical community's interest in this particular drug combination. The medications work through different mechanisms: encorafenib and binimetinib target specific cancer cell growth pathways, while pembrolizumab and other immunotherapy drugs help the immune system fight the cancer.
The concentration of trials in Central and Southern European countries suggests strong research infrastructure and patient populations in these regions for melanoma research. Both studies emphasize careful patient selection based on genetic testing and previous treatment history, reflecting the increasingly personalized approach to cancer treatment.
