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 tissue testing) that has spread to other parts of the body (stage IV).
• People who have at least one brain tumour spot, confirmed by a specific type of brain scan (MRI with contrast dye), that is 10mm or larger and shows clear signs of growth.
• People for whom a specific type of focused radiation treatment for brain tumours (stereotactic radiotherapy) is not recommended.
• People who finished any cancer treatment (chemotherapy, targeted therapy, immunotherapy, or radiation) at least 4 weeks before joining the trial.
• People whose blood test results meet certain levels — including white blood cell counts, platelet counts, haemoglobin (red blood cell measure), kidney function, protein levels, liver function, and a liver-related chemical called bilirubin — within the ranges required by the trial (confirm specific values with the trial site).
• People aged over 18 years old.
• People who are reasonably well and able to carry out daily activities, as measured by a standard scale used in cancer care (a score of 0, 1, or 2 on the ECOG scale — confirm with the trial site).
• Women of childbearing age who agree to use effective contraception starting 2 weeks before the first dose and continuing for 28 days after the last dose.
• Men who are able to father a child who agree to use effective contraception or abstain from intercourse from the first dose until one week after the last dose.
• Women of childbearing potential who have a negative pregnancy test within 14 days of enrolling and again within 48 hours before the first treatment.
• People who have read the participant information and signed the written consent form.

Who may not be able to join:

• People who are planned to receive, or are currently receiving, other systemic cancer treatments or radiation therapy at the same time as the trial.
• People who need steroid medication to reduce brain swelling but are not on a stable dose, or who require more than 4mg daily without approval from the lead trial doctor.
• People who have a known medical reason why they cannot have an MRI scan.
• People who have had another type of cancer, unless it went into complete remission at least 3 years before joining and no further treatment is needed or expected (certain early-stage or non-invasive cancers may be exceptions — confirm with the trial site).
• People with serious or uncontrolled other medical conditions, including active infections or active liver or kidney disease.
• People who are pregnant, likely to become pregnant, or are breastfeeding.
• People whose mental state, or personal, family, social, or geographical circumstances, may prevent them from understanding the study or following the required schedule.
• People who have taken part in another clinical drug trial within the 30 days before the screening visit.
• People whose melanoma has spread to the lining surrounding the brain and spinal cord (leptomeningeal metastases), confirmed by MRI.
• People currently enrolled in another treatment trial within the past 30 days.
• People who require steroid medication for brain metastasis symptoms but are not on the lowest effective dose.

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