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A Study of Dabrafenib and Trametinib Treatment Before and After Surgery in Patients with Papillary Craniopharyngioma

Fast replyRegistered drugNo placebo
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What is this trial about?

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

This study focuses on treating patients with papillary craniopharyngioma, which is a rare type of brain tumor that develops near the pituitary gland. The treatment involves two medications: dabrafenib and trametinib, which are targeted cancer therapies that work together to fight tumors with a specific genetic change called BRAF V600E mutation.

The purpose of this research is to determine how well these medications can shrink tumors before and after surgery. Both medications are taken by mouth - dabrafenib as capsules and trametinib as tablets. The treatment can continue for up to 12 months, during which regular brain scans using MRI (magnetic resonance imaging) will track any changes in tumor size.

During the study, doctors will monitor how the treatment affects various aspects of patients' health, including their vision, thinking abilities, and hormone function. They will also track how long the treatment benefits last and how it impacts overall quality of life. The medications may be given either before surgery to help shrink the tumor, or after surgery to prevent the tumor from coming back.

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

    Initial evaluation

    A medical evaluation will confirm if you have papillary craniopharyngioma with a specific genetic change called BRAF V600E mutation

    Your overall health and organ function will be assessed to ensure you can safely participate in the treatment

  2. Step 2

    Brain imaging

    An MRI scan will be performed to measure the size of your brain tumor

    This initial scan will serve as a reference point to track changes during treatment

  3. Step 3

    Treatment administration

    You will receive two medications: dabrafenib and trametinib

    Both medications are taken by mouth daily

    The treatment period will be determined by your doctor based on your response to the therapy

  4. Step 4

    Monitoring during treatment

    Regular MRI scans will be performed to measure changes in tumor size

    Your vision, cognitive function, and hormone levels will be monitored

    Quality of life assessments will be conducted periodically

    Your overall health will be regularly evaluated

  5. Step 5

    Treatment outcome evaluation

    The medical team will assess if the tumor has decreased in size

    If appropriate, the possibility of surgery will be evaluated

    Your progress will be monitored for up to 2 years to track long-term results

Who can join the trial?

7 criteria

  • Confirmed diagnosis of papillary craniopharyngioma through tissue examination (histological verification)
  • Presence of BRAF V600E mutation in the tumor, confirmed by two testing methods: - Examination of tumor tissue using special staining techniques - Genetic testing of the tumor
  • Either: - Newly diagnosed tumor, or - Tumor that has returned after previous surgery where additional surgery would cause serious or permanent complications
  • Age must be 18 years or older
  • Performance status score of 0-2 on the ECOG scale (ability to perform daily activities ranging from fully active to being up and about more than 50% of waking hours)
  • Normal functioning of major organs (such as liver, kidneys, bone marrow)
  • Both men and women can participate

Who cannot join the trial?

14 criteria

  • Age below 6 years or above 18 years
  • Previous treatment with BRAF inhibitors (medications that target specific proteins in cancer cells)
  • Known allergy or hypersensitivity to the study medications (dabrafenib and trametinib)
  • Presence of active infections requiring treatment
  • Significant heart problems or irregular heart rhythm
  • Severe liver dysfunction (poor liver function)
  • Severe kidney dysfunction (poor kidney function)
  • Current participation in other clinical trials
  • Inability to undergo MRI (Magnetic Resonance Imaging) scans
  • Pregnancy or breastfeeding
  • Unwillingness or inability to use effective contraception during the study
  • Any condition that, in the opinion of the study doctor, would make participation unsafe
  • Mental conditions that prevent understanding of the study requirements
  • History of other cancers in the past 5 years (except successfully treated non-melanoma skin cancer)
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Investigated drugs

Dabrafenib is a medication that belongs to a group called BRAF inhibitors. It works by blocking a specific protein that can cause tumor growth. This medication is used to treat certain types of tumors by targeting cells that have a specific genetic change (mutation). Trametinib is a medication that works together with dabrafenib. It belongs to a group called MEK inhibitors. This medication helps block different proteins that are involved in cancer cell growth and survival. When used together with dabrafenib, it can be more effective in treating certain types of tumors. These medications are used together in this trial to treat papillary craniopharyngioma, which is a type of brain tumor, before and after surgery. The treatment aims to shrink the tumor and prevent it from growing back after surgical removal.

What is already known about the treatment

  • Dabrafenib

    An oral medication taken in capsule form that belongs to the class of targeted cancer therapies known as BRAF inhibitors. This drug works by blocking the activity of mutated BRAF proteins that can cause tumor growth, specifically targeting the BRAF V600 mutation found in some types of tumors. It is primarily used in the treatment of certain types of cancers, including specific brain tumors, and is often prescribed in combination with trametinib for enhanced therapeutic effect.

  • Trametinib

    An oral medication administered as a tablet that belongs to the class of MEK inhibitors used in targeted cancer therapy. This drug works by blocking MEK proteins that are involved in cancer cell growth and survival pathways, complementing the action of BRAF inhibitors. It is commonly used in combination with dabrafenib to provide a dual-blocking mechanism against cancer cell proliferation, showing particular effectiveness in treating tumors with BRAF mutations, including certain types of brain tumors.

Investigated diseases

Papillary Craniopharyngioma – A slow-growing brain tumor that develops from remnants of embryonic tissue near the pituitary gland and hypothalamus. This benign tumor typically forms in the sellar and suprasellar regions of the brain, containing both solid components and fluid-filled cysts. Papillary craniopharyngioma most commonly affects adults, showing distinct features under microscopic examination with finger-like projections of tissue. The tumor can gradually expand and press on nearby brain structures, including the optic nerves and pituitary gland. As it grows, it may affect various functions controlled by the hypothalamus and pituitary gland.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517611-67-00Protocol codeSwecranio1-21Estimated enrolment25 patientsSponsorRegion Skane

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