In short
There are currently 2 ongoing clinical trials investigating new treatments for cancers with BRAF gene mutations. These studies are testing medications that target specific changes in the BRAF gene, which plays a key role in cancer cell growth. The trials are taking place across several European countries and involve medications designed to block the proteins that allow cancer cells to multiply and spread.
Clinical trial locations
- France
- Germany
- Italy
- Norway
- Spain
- Sweden
Study on the Effectiveness and Safety of Plixorafenib (FORE8394) for Patients with Cancer Having BRAF Alterations
This trial is investigating a new medication called Plixorafenib, designed to target specific changes in the BRAF gene found in certain cancers. The study focuses on patients with advanced solid tumors or brain tumors that have particular BRAF alterations, including BRAF fusions or the BRAF V600E mutation.
Who can participate: The trial is open to patients aged 10 years or older who weigh at least 30 kilograms. Participants must have a confirmed diagnosis of either a solid tumor or a brain tumor with specific BRAF gene changes that have been detected through validated testing. The tumor must be measurable using imaging techniques, and participants must have completed all available standard treatments or be unable to tolerate them. Any previous treatment side effects must have improved to a mild level, with the exception of hair loss or mild nerve damage. Those taking corticosteroids must be on a stable or decreasing dose for at least seven days before starting the study treatment.
Who cannot participate: The trial excludes patients whose tumors do not have BRAF gene changes, those outside the specified age range, and anyone unable to follow study procedures or take the medication as required. Patients who are pregnant or breastfeeding, those currently in another clinical trial, or individuals recovering from major surgery are not eligible. The study also excludes patients with certain heart problems, active infections requiring treatment, or known allergies to the study medication or its ingredients.
What the trial involves: Participants will receive Plixorafenib as oral tablets. The main goal is to evaluate how effective the medication is at treating cancers with BRAF alterations and to monitor its safety profile. Throughout the study, which lasts up to 120 days, participants will undergo regular assessments including scans and laboratory tests to track tumor changes and overall health. The study measures outcomes such as overall response rate, duration of response, progression-free survival, and overall survival.
Investigational drug: Plixorafenib works by targeting and inhibiting the activity of BRAF proteins, which are involved in cell growth and division. By blocking these proteins, the medication may help slow or stop the growth of cancer cells in tumors with BRAF alterations.
Study on Treating Advanced Cancers with BRAF Mutations Using Sorafenib and Trametinib for Patients with Impaired Kinase Activity
This trial examines the combination of two medications, Sorafenib (also known as Nexavar) and Trametinib (also known as Mekinist), for treating advanced cancers with BRAF mutations that affect kinase activity. The study aims to find the best dose of these medications when used together.
Who can participate: The trial is open to patients aged 18 years or older with metastatic cancer that has spread to other parts of the body. Participants must have experienced cancer progression despite standard treatment and have a BRAF mutation with impaired kinase activity that is sensitive to sorafenib, as confirmed by laboratory tests. Patients must have at least one measurable area of abnormal tissue visible on imaging tests such as CT, PET-CT, or MRI. Adequate liver function is required, with specific blood test results within certain limits, and kidney function must show a calculated creatinine clearance of at least 50 mL/min. Participants must be able to swallow and retain oral medication without significant digestive issues.
Who cannot participate: The trial excludes patients who do not have advanced-stage cancer with BRAF mutations, those outside the specified age range, patients from vulnerable populations who may need special protection, and anyone who cannot tolerate the combination of trametinib and sorafenib.
What the trial involves: Participants receive both medications as oral tablets. Sorafenib is given at a dose of 200 mg and Trametinib at 0.5 mg, with the specific dosage and frequency determined by the trial phase and individual patient response. The study monitors participants regularly for side effects and assesses disease control using imaging techniques. The primary goal is to determine the maximum tolerated dose and the recommended dose for future study phases. The trial is estimated to conclude by September 30, 2027.
Investigational drugs: Trametinib works by inhibiting a protein called MEK, which is involved in cancer cell growth and spread. Sorafenib blocks multiple proteins that promote cancer cell growth, targeting various pathways that cancer cells use to grow and spread. Together, these medications may help control the progression of cancers with specific BRAF mutations.
Summary
Both trials focus on treating cancers with BRAF gene mutations using targeted therapies that block the proteins responsible for cancer cell growth. The first trial, available across multiple European countries including France, Germany, Italy, Norway, Spain, and Sweden, tests a single medication called Plixorafenib and includes younger patients from age 10. The second trial, conducted only in Germany, examines a combination of two medications, Sorafenib and Trametinib, and is limited to adult patients aged 18 and older.
These studies reflect the growing understanding of how genetic changes drive cancer development and the importance of developing treatments that target these specific alterations. While Germany hosts both trials, the broader European availability of the Plixorafenib study provides more opportunities for patients across the continent to access this investigational treatment. Both studies emphasize the need for confirmed BRAF alterations through validated testing and require participants to have exhausted standard treatment options.
