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Study on Treating Advanced Cancers with BRAF Mutations Using Sorafenib and Trametinib for Patients with Impaired Kinase Activity

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 advanced-stage cancers that have a specific change in their genes known as BRAF mutations. These mutations affect how certain proteins work in the body. The study is testing a combination of two medications: Sorafenib and Trametinib. Sorafenib is also known by the brand name Nexavar, and Trametinib is known as Mekinist or by its code name GSK1120212B. Both medications are taken as film-coated tablets by mouth.

The purpose of the study is to find the best dose of these medications when used together. Participants will receive both Sorafenib and Trametinib to see how their cancer responds to the treatment. The study will monitor how well the treatment works and any side effects that may occur. The trial will continue until the researchers determine the most effective and safe dose for future studies.

Participants in the study will have regular check-ups and tests, such as MRI or CT scans, to measure the size of their cancer and assess their overall health. The study aims to provide valuable information that could lead to better treatment options for people with cancers that have BRAF mutations.

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

    Joining the study

    Upon joining the study, the patient must have a confirmed diagnosis of advanced-stage malignancies with BRAF mutations that affect kinase activity.

    The patient must have experienced progression after standard treatment and have at least one measurable lesion.

  2. Step 2

    Initial assessment

    The patient undergoes an initial assessment to confirm eligibility, including tests to ensure adequate liver and kidney function.

    The patient must be able to swallow and retain oral medication.

  3. Step 3

    Medication administration

    The patient receives Mekinist (trametinib) 0.5 mg and Nexavar (sorafenib) 200 mg, both in the form of film-coated tablets.

    Both medications are taken orally. The specific dosage and frequency are determined based on the trial's phase and the patient's response.

  4. Step 4

    Monitoring and follow-up

    The patient is monitored regularly for any side effects or adverse events. This includes both common and serious adverse events.

    The patient's disease control rate is assessed using imaging techniques like CT, PET-CT, or MRI.

  5. Step 5

    Trial completion

    The trial aims to determine the maximum tolerated dose of the medication combination and the recommended dose for further study phases.

    The estimated end date for the trial is September 30, 2027.

Who can join the trial?

11 criteria

  • Patients must be **18 years or older**. There is no upper age limit.
  • Patients must have a **metastatic malignancy**, which means cancer that has spread to other parts of the body.
  • Patients must have experienced **progression after standard treatment**, meaning their cancer has continued to grow or spread despite usual treatments.
  • Patients must have a **BRAF mutation** with impaired kinase activity. This is a specific change in the cancer's genetic material that affects how the cancer grows.
  • Patients must have a **BRAF mutation** that is sensitive to sorafenib, a type of cancer medication, as determined by laboratory tests.
  • Patients must have at least one **lesion** (an area of abnormal tissue) that can be measured using imaging tests like CT, PET-CT, or MRI.
  • Patients must have **adequate liver function**, which means their liver is working well enough, with specific blood test results for AST, ALT, and bilirubin within certain limits.
  • Patients must have a **calculated creatinine clearance** of at least 50 mL/min. This is a measure of how well the kidneys are working.
  • Patients must be able to **swallow and retain oral medication** and should not have significant digestive issues that could affect how the medicine is absorbed.
  • Patients must provide **written informed consent**, which means they agree to participate in the study after being fully informed about it.
  • Patients must be able to **understand the nature of the trial** and follow the trial procedures.

Who cannot join the trial?

4 criteria

  • Patients who do not have **advanced-stage cancer** with specific genetic changes called **BRAF mutations**.
  • Patients who are not within the specified age range for the trial.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
  • Patients who cannot tolerate the combination of the drugs **trametinib** and **sorafenib**.
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Investigated drugs

  • Trametinib

    is a medication used in this trial to inhibit a protein called MEK, which is involved in the growth and spread of cancer cells. By blocking this protein, trametinib may help slow down or stop the progression of certain types of cancer.

  • Sorafenib

    is another medication used in the trial that works by blocking certain proteins that promote cancer cell growth. It targets multiple pathways that cancer cells use to grow and spread, potentially helping to control the disease.

What is already known about the treatment

  • Trametinib

    This medication is administered orally and is currently being studied in combination with sorafenib for treating advanced-stage cancers with specific BRAF mutations. It is primarily used to inhibit MEK, a protein involved in cell growth, thereby slowing down cancer progression. Trametinib is classified as a MEK inhibitor and is being evaluated to determine the optimal dosage when used with sorafenib.

  • Sorafenib

    This medication is taken orally and is under investigation for its effectiveness in combination with trametinib for certain advanced cancers with BRAF mutations. Sorafenib works by inhibiting multiple kinases, which are proteins that promote cancer cell growth, thus helping to control tumor development. It is classified as a multikinase inhibitor and is being studied to establish the best dose when used alongside trametinib.

Investigated diseases

Advanced-Stage Malignancies with BRAF Mutations – These are cancers that have progressed to an advanced stage and contain specific mutations in the BRAF gene, which affect the kinase activity within cells. The BRAF gene is involved in cell growth, and mutations can lead to uncontrolled cell division. These malignancies can occur in various parts of the body, including the skin, thyroid, and colon. The presence of BRAF mutations often indicates a more aggressive form of cancer. As the disease progresses, it may spread to other parts of the body, complicating treatment and management. Understanding the specific mutation type is crucial for determining appropriate therapeutic strategies.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-512887-77-00Protocol code1056 SORATRAMEstimated enrolment30 patientsSponsorMedical Center - University Of Freiburg

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