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 whose general health and ability to carry out daily activities meets a minimum level of functioning, assessed using a standard scale (confirm with trial site)
• People whose melanoma has been confirmed through laboratory testing of tissue or cell samples
• People with melanoma that cannot be surgically removed and has reached an advanced stage (Stage III or IV), where local treatment is not an option
• People whose melanoma shows measurable tumours that can be tracked using standard imaging guidelines
• People whose melanoma has been confirmed to have a specific genetic change called a KIT mutation, tested through an approved laboratory
• People whose melanoma has progressed after standard treatment, or who are not suitable for or cannot tolerate standard treatment, in the treating doctor's opinion
• People who have previously received immune checkpoint therapy (a type of cancer treatment), provided the last dose was given at least 4 weeks before starting this trial
• People with blood counts and organ function within acceptable ranges, including white blood cells, platelets, liver function, and kidney function (confirm with trial site for specific values)
• People living with HIV who are on effective treatment and have had an undetectable viral load within the past 3 months
• People with chronic hepatitis B who have an undetectable viral load while on appropriate treatment
• People with a history of hepatitis C who have been successfully treated and cured, or who are currently being treated and have an undetectable viral load
• People with brain metastases (cancer that has spread to the brain) or disease affecting the lining of the brain and spinal cord, if the treating doctor determines that immediate brain-specific treatment is not needed before starting the trial
• People who have had or currently have another cancer, as long as that cancer or its treatment is unlikely to affect the safety or results of this trial
• Women who are able to become pregnant and who agree to use highly effective contraception from the screening period until 30 days after the last dose, avoid donating eggs during that time, and immediately inform their treating doctor if they become or suspect they are pregnant
• Men who are sexually active and who agree to use a condom throughout the trial and for 90 days after the last dose, avoid donating sperm during that time, ensure their partner (if able to become pregnant) also uses highly effective contraception, and immediately inform their treating doctor if their partner becomes pregnant
• People who are able to understand and are willing to sign a written consent form
• People who, in the investigator's judgment, are likely to attend scheduled visits and follow the study plan

Who may not be able to join:

• People who have received systemic cancer treatment within 3 weeks, radiation within 2 weeks, or antibody-based cancer therapy within 4 weeks before the trial start date
• People who have not recovered from side effects of previous cancer treatment (unless the ongoing effects are stable, mild, and not expected to resolve, such as nerve pain, hair loss, or hormone-related conditions from prior therapy)
• People who are currently taking part in another clinical trial or who have received an experimental treatment within 14 days (or within 5 half-lives of that treatment, whichever is shorter) before starting this trial
• People who are unable to swallow and keep down the trial medications
• People with digestive system problems that could significantly affect how the trial medications are absorbed, such as active ulcers, uncontrolled vomiting or diarrhoea, malabsorption conditions, complete removal of the small bowel, or a history of bowel blockage within the past 3 months
• People with a known allergic reaction to binimetinib or any of its ingredients
• People with a known allergic reaction to imatinib or any of its ingredients
• People with a muscle or nerve condition that causes elevated levels of a specific enzyme called creatine kinase (for example, certain types of muscular disease or motor neurone disease)
• People with a history of a blocked vein in the eye (retinal vein occlusion), current risk factors for this condition such as uncontrolled eye pressure or glaucoma, or a history of degenerative eye disease
• People with significant heart problems, including a heart attack or related event within the past 6 months, moderate to severe heart failure, reduced heart pumping function, uncontrolled high blood pressure, significant heart rhythm problems, or an abnormal heart electrical reading above a certain threshold (confirm with trial site)
• People taking certain prohibited medications, herbal products, supplements, or foods that cannot be safely stopped before starting the trial
• People taking warfarin (a blood-thinning medication) who cannot safely switch to a different blood-thinning medication
• People who have had a significant blood clot or stroke-related event within 12 weeks before the first dose (note: people with a stable, non-severe blood clot who have been on a stable dose of blood-thinning medication for at least 4 weeks may still be considered)
• Women who are pregnant, as the trial medications may harm an unborn baby
• Women who are breastfeeding, as the trial medications may affect a nursing infant
• People with other serious medical or psychiatric conditions, or significant abnormal test results, that in the investigator's judgment would make participation unsafe or affect the reliability of the trial results

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