Phase 3 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 aged 18 or older who have been diagnosed with brain metastases that have not yet been treated (other than surgery)
• People whose brain metastases are causing no symptoms, or only mild symptoms that do not require more than a low, stable dose of steroid medication (4 mg dexamethasone equivalent or less, for no more than one week)
• People with between 1 and 10 brain metastases, where at least one is 5 mm or larger in diameter, and the largest is no more than 30 mm across
• People with 5 to 10 brain metastases where the largest tumour is no more than 10 mL in volume, and the total combined volume of all brain metastases is no more than 30 mL
• People whose cancer has been confirmed by tissue testing as either melanoma or a type of lung cancer called non-small cell lung cancer (NSCLC)
• People with melanoma who may have had prior treatments (including immunotherapy) for their melanoma elsewhere in the body, as long as the brain metastases are newly found and untreated — BRAF mutation test results should be known
• People with NSCLC whose cancer has newly spread and has not yet been treated with systemic therapy — results of PD-L1 testing and genetic driver mutation testing should be known
• People who are considered well enough to receive systemic (whole-body) treatment, with a Karnofsky performance score of 60 or higher (confirm with trial site)
• People with a life expectancy of more than 12 weeks
• People who have had prior brain surgery (including biopsy, resection, or cyst drainage) may still be eligible, and a brain scan taken within 72 hours after surgery should be available
• Women who could become pregnant must have a negative pregnancy test within 7 days before joining the trial
• People who are willing and able to sign a written consent form before any trial-related procedures begin

Who may not be able to join:

• People whose cancer has spread to the lining of the brain or spinal cord (leptomeningeal metastases)
• People with brain metastases that are causing significant symptoms requiring more than a low stable steroid dose at the time of joining the trial
• People who have previously received radiation therapy to the whole brain or targeted radiation (focal radiotherapy) to the brain
• People who have previously received systemic (whole-body) treatment specifically for their brain metastases
• People for whom stereotactic radiosurgery (a precise type of radiation treatment) is not medically suitable (confirm with trial site)
• People who, in the opinion of the trial doctor, are unlikely to follow the trial procedures and requirements
• Women who are pregnant or currently breastfeeding
• People who are sexually active and able to have children but are not willing to use an effective form of contraception during the trial

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