Phase 3 Rare Disease Trial, Not Yet Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You have been diagnosed with a cancer or condition (including Langerhans cell histiocytosis) that has a specific gene change called BRAF V600, confirmed using an advanced genetic testing method.
• You are at least 1 year old and weigh at least 8 kg (about 17.6 lbs).
• If you are a woman who could become pregnant, you must have a negative pregnancy test before joining and agree to use a non-hormonal highly effective contraceptive method (such as an IUD, tubal ligation, vasectomised partner, or complete abstinence) from the start of treatment until at least 2 weeks after your last dose of dabrafenib or 16 weeks after your last dose of trametinib, whichever is later.
• If you are currently breastfeeding, you must be willing to stop from the start of treatment through the same period described above.
• If you are a male with a partner who could become pregnant, you must agree to use a condom (plus spermicide) or abstain from sex during treatment and for up to 16 weeks after your last dose, and must not donate sperm during this time.
• You must be willing and able to provide a tissue sample (biopsy) at the start of the trial and blood samples for research purposes.
• Your liver, kidneys, blood, and other organs must be functioning well enough, based on blood tests, as set out in the trial guidelines.

Who may not be able to join:

• Adults (18 or older) who have been diagnosed with colorectal cancer, unresectable or metastatic melanoma, or advanced non-small cell lung cancer with the BRAF V600E mutation.
• Children or young people (aged 1 to under 18) who have a brain tumour (glioma) with a BRAF V600E mutation.
• You have previously been treated with dabrafenib and trametinib together, or any other combination of BRAF and MEK inhibitor drugs, for your current condition.
• Women who are currently pregnant, breastfeeding, or planning to become pregnant during the trial or within the required time after treatment ends.
• You have a known allergy or sensitivity to dabrafenib, trametinib, or any of their ingredients.
• You have a history of a blockage in the vein at the back of the eye (retinal vein occlusion).
• You have a significant digestive or gut condition that is not well controlled and could affect how the trial drugs are absorbed (for example, uncontrolled Crohn's disease, severe diarrhoea, vomiting, or malabsorption conditions).
• You have significant heart or blood vessel problems, such as unstable chest pain (angina), a heart attack, or severe heart failure within the last 3 months, or a stroke or mini-stroke (TIA) within the last 3 months (confirm specific details with trial site).
• You have received a live vaccine (such as MMR or yellow fever) within 28 days before starting treatment, or expect to need one during treatment or within 6 months of finishing.
• You have an active serious infection (bacterial, fungal, or viral) that could affect the trial results or your safety.
• You are HIV-positive, unless your HIV is very well managed with stable treatment, your immune system is strong enough, and you have had no HIV-related infections in the past 12 months (confirm with trial site).
• You have any other significant health condition or are taking other medications that the trial doctor believes would make it unsafe for you to participate (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.