Phase 2 Melanoma Trial, 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:

• People who have given written agreement to participate before any trial activities begin.
• People who have been confirmed by laboratory testing to have melanoma that cannot be removed by surgery, has spread to other parts of the body (stage IV), and has one or more tumours in the brain measuring between 5 and 50 mm, as seen on a contrast MRI scan.
• People whose brain tumour(s) are causing symptoms, such as signs of increased pressure in the brain, weakness or other problems with movement or feeling on one side of the body, or seizures — with or without those symptoms being managed by steroids.
• People whose tumour has been tested and confirmed to carry a specific gene change called BRAF-V600 mutation.
• People who score above 10 on a standard scale that measures ability to carry out daily activities (the Modified Barthel Index) (confirm with trial site).
• People aged 18 or older.
• People who are reasonably well and able to carry out some daily activities, as measured by a standard medical scoring system called ECOG PS 0–2 (confirm with trial site).
• People who are able to swallow tablets or capsules.
• People with blood counts that meet the required levels: haemoglobin at least 9 g/dL, platelets at least 75 × 10⁹/L, and neutrophils at least 1.5 × 10⁹/L.
• People whose liver function tests fall within the required ranges as measured by standard blood tests (confirm with trial site for specific values).
• People whose kidney function meets the required levels, based on a blood or urine test (confirm with trial site for specific values).
• People who previously received immunotherapy only as a treatment given before or after surgery (adjuvant or neoadjuvant), provided any serious side effects from that treatment have fully resolved.
• People who are taking steroids or anti-seizure medications if needed for their symptoms, as long as the steroid dose has not been increasing in the 5 days before starting the trial.
• Women who could become pregnant must have a negative pregnancy test at the start of the trial and must agree to use a highly effective form of contraception during treatment and for 6 months after the last dose.
• Male participants whose partners could become pregnant must agree to use condoms during the trial and for 6 months after the last dose, unless they have had a vasectomy or practise complete abstinence.
• Women who could become pregnant must agree not to donate eggs during the trial and for 6 months after the last dose; all male participants must agree not to donate sperm during the trial and for 6 months after the last dose.
• People who are willing and able to attend scheduled visits, follow the treatment plan, and complete all required tests and procedures.

Who may not be able to join:

• People with a type of eye melanoma called uveal melanoma.
• People with a history of melanoma spreading to the lining of the brain (leptomeningeal metastases), unless it is an incidental finding on the MRI that does not explain the person's main neurological symptoms, as determined by the treating doctor.
• People who have had another cancer that has not been fully cured in the last 2 years, with some exceptions for certain early-stage or fully treated skin, cervical, breast, or prostate cancers (confirm with trial site for specific exceptions).
• People who have had an organ transplant from another person.
• People with a history of, or current, certain eye conditions affecting the retina (central serous retinopathy, retinal vein occlusion, or retinal degenerative disease).
• People with a history of interstitial lung disease (a condition causing scarring or inflammation of the lungs).
• People who previously received immunotherapy for melanoma in a setting other than before or after surgery, or who received a type of immunotherapy called anti-LAG-3, or who had brain metastases before starting that immunotherapy, or who stopped immunotherapy due to side effects (confirm with trial site for the full list of related conditions).
• People who have previously received any targeted therapy aimed at BRAF or MEK, in any setting including before or after surgery.
• People who have previously received chemotherapy in any setting.
• People who need urgent brain surgery before joining the trial (though people who have already had brain surgery may be eligible if they still meet all other criteria and have at least one measurable tumour remaining).
• People who have previously received radiotherapy to the brain.
• People who have had a significant infection requiring antibiotic treatment in the 2 weeks before the first dose of trial medication.
• People with an active infection currently requiring treatment.
• People with an ongoing or recent (within the last 2 years) autoimmune disease that required treatment with immune-suppressing medication (some conditions such as vitiligo, resolved childhood asthma, thyroid hormone replacement, or psoriasis not needing systemic treatment are not excluded).
• People with uncontrolled HIV, hepatitis B, or hepatitis C infection, or a diagnosis of immune deficiency linked to a chronic infection (people with these conditions that are well-controlled on appropriate treatment may still be eligible — confirm with trial site).
• People with significant heart or blood vessel problems, such as a stroke or heart attack in the past 6 months, unstable chest pain, significant heart failure, a heart pumping function below 50%, serious heart rhythm problems, or a history of heart muscle inflammation (confirm with trial site).
• People with certain elevated heart enzyme (troponin) levels in blood tests at the start of the trial (confirm with trial site for specific thresholds).
• People with high blood pressure that cannot be controlled with medication.
• People with moderate or severe liver disease (Child Pugh Class B or C).
• People with digestive system problems that affect their ability to swallow or absorb tablets or capsules.
• People with muscle diseases associated with high levels of a substance called creatine kinase.
• People who have been diagnosed with an immune deficiency or have been taking immune-suppressing medications (other than steroids for brain metastasis symptoms) within the 28 days before the first trial dose.
• People with a history of lung inflammation (pneumonitis) in the last 5 years.
• People with active inflammatory bowel disease, such as Crohn's disease or ulcerative colitis.
• People with medical, psychiatric, or cognitive conditions that may prevent them from understanding the trial information, giving informed consent, or following the study requirements.
• People with a known allergy to any of the trial medications or their ingredients.
• People with ongoing side effects from previous treatments rated above Grade 1 in severity, except for hair loss or mild nerve-related symptoms (confirm with trial site).
• People who have received a live vaccine within 30 days before the planned start of trial treatment.
• Women who are pregnant or breastfeeding, or any person of reproductive potential who is not willing to use highly effective contraception from the screening period until 6 months after the last dose.
• People with known alcohol or drug dependency.
• People who have taken part in another interventional drug or medical device trial within 30 days before the start of treatment.
• People with a rare inherited condition affecting the ability to digest certain sugars (total lactase deficiency or glucose-galactose malabsorption).

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