Phase 2 Melanoma Trial, Recruiting

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

Who might be able to join this trial:

• People who are able to give written consent to participate in the study
• People who are 18 years of age or older at the time of giving consent
• People who have been diagnosed with melanoma confirmed through laboratory tissue testing
• People whose melanoma tumour has been found to carry a specific genetic change called BRAF V600 mutation, detected by a laboratory test at any point before or during the screening period
• Cohort A (one group): People with BRAF V600 mutant melanoma whose cancer has spread to the brain or the fluid and lining around the brain and spine (called leptomeningeal disease), and whose brain cancer is getting worse
• Cohort A: People who have previously been treated with BRAF-blocking drugs (with or without MEK-blocking drugs) approved by the US medicines authority (FDA) — no break between that treatment and this trial is required
• Cohort A: People who have previously received immunotherapy or other experimental treatments are eligible, provided at least 14 days have passed since the last dose
• Cohort B (another group): People with BRAF V600 mutant melanoma who have cancer that has spread to the brain or leptomeningeal disease, and who have never been treated with BRAF- or MEK-blocking drugs before — prior immunotherapy is permitted in this group
• People who have at least one actively growing brain tumour spot measuring between 0.5 cm and 3 cm that can be clearly seen on an MRI scan (for those with brain tumour spread but not leptomeningeal disease)
• People with leptomeningeal disease who have evidence of this condition confirmed by imaging or by testing the fluid around the brain and spine, as assessed by the study doctor
• People whose general physical functioning is rated at 0, 1, or 2 on a standard medical scale (ECOG scale), meaning they are able to care for themselves and are up and about for more than half of waking hours (confirm with trial site)
• People who are taking low-dose steroid medication to manage brain-related symptoms, within specific dose limits depending on whether they have brain tumour spread or leptomeningeal disease (confirm with trial site for exact dose requirements)
• People who have previously had radiation treatment to the brain or spine, provided a minimum waiting period has passed since that treatment (at least 7–14 days depending on the type of radiation and disease location)
• People who have had previous immunotherapy or other experimental treatments, provided at least 14 days have passed since the last dose
• People who have had previous treatment directly into the spinal fluid (intrathecal therapy), provided at least 7 days have passed since the last dose
• People who have received chemotherapy, provided at least 21 days have passed since the last dose
• People whose blood test results meet the required levels for blood cell counts, liver function, kidney function, and blood clotting (confirm specific values with trial site)
• Women of childbearing potential who have a negative pregnancy test before starting the trial
• Women of childbearing potential and men who agree to use approved contraception methods throughout the study and for a set period after the last dose, and agree not to donate eggs or sperm during that time
• People who the study doctor believes are able and willing to attend all scheduled visits and follow the study plan

Who may not be able to join:

• People who have had an active infection within 7 days before starting the study drug (with some exceptions for certain viral infections linked to the cancer type being studied)
• People who have received a live-virus vaccine (not including inactivated vaccines such as flu shots) within 30 days before starting the study drug
• People who are unable to swallow and keep down the study medication
• People with a known history of HIV or AIDS, even if their immune system is well controlled with medication
• People who have had a serious heart event such as a heart attack, unstable chest pain, or heart bypass surgery within 6 months before screening
• People with heart failure that requires treatment and significantly limits physical activity
• People whose heart pumping function (left ventricular ejection fraction) is below 50% on a heart scan
• People with a significant heart rhythm problem, including a consistently slow heart rate, uncontrolled irregular heartbeat, or uncontrolled episodes of rapid heartbeat
• People with a specific abnormal heart electrical reading (QTcF interval of 480 milliseconds or more) on an ECG
• People with a neuromuscular condition affecting the muscles or nerves, such as muscular dystrophy or ALS (confirm with trial site for full list)
• People with significant problems with digestion or absorption of food, including uncontrolled nausea, vomiting, diarrhoea, or a history of pancreatitis
• People with a history of a blood clot blocking a vein in the eye (retinal vein occlusion), or conditions that increase the risk of this, such as uncontrolled glaucoma or certain clotting disorders; or a history of retinal degeneration
• People who have taken herbal supplements or medications that strongly affect how the body processes certain drugs (moderate or strong CYP3A4/5 inhibitors or inducers) within 1 week before starting the study
• People who have had a serious blood clotting event (such as a stroke, blood clot in the leg, or blood clot in the lungs) within 12 weeks before starting the study — with some exceptions for clots related to catheters or for people who are stable and on consistent blood-thinning medication (confirm with trial site)
• People with active hepatitis B or hepatitis C infection (people with cleared past infections may still be eligible — confirm with trial site)
• People who are pregnant, breastfeeding, or planning to become pregnant during the study
• People with other serious medical or mental health conditions that the study doctor believes would make participation unsafe or affect the reliability of study results

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