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 non-uveal melanoma (a type of skin or mucous membrane cancer, not eye melanoma) that has spread to the brain, with at least one brain tumour measuring between 5 and 40mm that has not previously been treated with targeted radiation (called SRS)
• People aged 18 or older
• People whose general health and ability to carry out daily activities meets a certain level — one group for those without brain-related symptoms, and another group for those with mild to moderate symptoms (confirm with trial site)
• People who have not previously received certain immunotherapy treatments (anti-CTLA-4, anti-PD-1, or anti-LAG-3 drugs) for advanced or spreading melanoma — though prior use of these drugs in an early-stage preventive setting may be acceptable if it was more than 6 months ago
• People whose liver, kidney, and other organ functions are within acceptable ranges based on recent blood tests
• People who have recovered from side effects of previous cancer treatments, with most side effects reduced to a mild level before joining
• People with no brain-related symptoms who have not needed steroid medications above a low threshold in the 10 days before starting the study, OR people with brain-related symptoms who are on a stable or reducing low dose of steroids (no more than 4mg of dexamethasone per day or equivalent)
• People living with HIV, provided they are on effective treatment and have an undetectable viral load tested within the past 90 days
• People with a history of hepatitis B or C who have been successfully treated, or who are currently being treated and have an undetectable viral load
• People who are able to provide a tumour tissue sample (or have one available from a previous biopsy) for testing — though people without available tissue may still be considered for enrolment (confirm with trial site)
• People who have had radiation or surgery on non-target brain lesions at least 1 week before starting the study, as long as the treated area did not include the main tumour being measured
• People who have had radiation to areas outside the brain, with any related side effects reduced to a mild level
• Women who could become pregnant must have a negative pregnancy test within 3 days before starting treatment, must not be breastfeeding, and must agree to use an approved form of contraception during treatment and for 12 months after the last dose
• People who are able to understand the study requirements and are willing to provide written consent to participate

Who may not be able to join:

• People diagnosed with another separate cancer within the past 3 years (some exceptions apply for certain early-stage or treated cancers — confirm with trial site)
• People with active serious medical conditions, including active infections (such as COVID-19), blood clotting disorders, or significant heart, lung, or immune system illnesses
• People with an active autoimmune disease that has required steroid or immunosuppressive treatment within the past 3 years
• People who have an implanted device in their body that prevents them from having an MRI scan
• People who previously had a severe (Grade 4) reaction to immunotherapy treatment
• People who have had melanoma spread to the lining around the brain or spinal cord (leptomeningeal metastasis), confirmed by imaging or lumbar puncture
• People who have previously had whole-brain radiation therapy
• People who are pregnant or breastfeeding
• People with a significant heart condition, including heart failure above a certain level of severity, unstable chest pain at rest, a new heart condition within the last 3 months, a heart attack within the past 6 months, or a history of heart muscle inflammation
• People with certain elevated levels of heart-related proteins (troponin) in their blood, above a specified threshold — some borderline cases may be considered following a heart specialist's review (confirm with trial site)
• People who have used another experimental drug within 14 days (or longer, depending on the drug) before starting this study
• People taking dexamethasone at a dose higher than 4mg per day (or an equivalent dose of another steroid)

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