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 have been diagnosed with melanoma (confirmed by lab testing) that has spread to the brain, from any primary site such as the skin, except uveal (eye) melanoma.
• People whose melanoma has a specific gene change called a BRAF-V600 mutation, confirmed by an approved laboratory.
• People who have had a brain MRI scan within the past 28 days showing at least one brain tumour spot that is 0.5 cm or larger and has either not been treated with radiation, or has grown back after radiation treatment.
• People who may or may not have melanoma that has spread to other parts of the body outside the brain — spread outside the brain is not required to join.
• People who may have a type of cancer spread called leptomeningeal disease (cancer cells in the fluid around the brain and spine).
• People who are taking a steroid called dexamethasone for brain swelling, as long as the dose has not exceeded 8 mg per day for at least the past 7 days.
• People who are generally well enough to carry out some daily activities, as assessed using a standard medical performance scale (Zubrod score of 2 or lower).
• People who are able to swallow and keep down tablets or pills.
• People whose recent blood test results show that blood cell counts and organ function (liver, kidneys) are within acceptable ranges, as confirmed within 28 days before joining.
• People with a history of heart disease may still be eligible, provided a doctor assesses their heart function and it meets a minimum standard (New York Heart Association class 2B or better).
• People who have had or currently have another type of cancer, if the treating doctor believes it will not interfere with the trial treatment or safety assessments.
• People living with HIV, provided they are on effective HIV treatment and their most recent viral load test (within 90 days) shows the virus is undetectable.
• People with a past hepatitis C infection who have been fully treated and cured, or who are currently being treated and have an undetectable viral load.
• People who agree to have their scan images submitted to an image banking system for research purposes.
• People who agree to the possibility of providing blood and tissue samples for research (participation is offered but may be optional — confirm with trial site).
• People who have been fully informed about the trial and have signed a consent form agreeing to participate.

Who may not be able to join:

• People who have already received systemic (whole-body) treatment for metastatic melanoma — however, treatment given before or after surgery as a preventive measure (adjuvant or neoadjuvant therapy) may be acceptable, provided the melanoma later came back.
• People who have had radiation therapy within 7 days before joining the trial.
• People who are planning to receive any other anti-cancer treatment for melanoma at the same time as the trial treatment.
• People who are planning to use hormonal contraception (such as the pill or hormonal implants) during the trial, as one of the trial drugs can reduce how well these work.
• People who have a serious active infection that requires treatment at the time of joining.
• People with an active autoimmune condition (where the immune system attacks the body) that has required treatment with certain strong biologic medications in the past 6 months — people on lower-dose steroids or non-biologic medications may still be eligible (confirm with trial site).
• People who previously had severe (grade 3 or 4) immune-related side effects from the drugs ipilimumab or nivolumab that required more than 12 weeks of steroid treatment to manage.
• People who previously had to stop taking the specific drugs encorafenib and/or binimetinib due to side effects from those particular drugs.
• People who are pregnant or breastfeeding, or people of reproductive potential who are not willing to use an effective non-hormonal method of contraception during the trial.

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