Phase 2 Melanoma Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older, of any gender
• People whose general health and ability to carry out daily activities meets a specific fitness standard (called WHO Performance Status 0 or 1 — confirm with trial site)
• People with a confirmed diagnosis of skin melanoma that has grown to a deeper stage (stage pT3-4, meaning the tumour is thicker than 2.0mm), based on tissue testing
• People whose risk of melanoma spreading to nearby "sentinel" lymph nodes is calculated at 44% or higher, using a specific online risk prediction tool
• People whose primary melanoma was surgically removed no more than 4 weeks before joining the trial
• People who have not yet had a re-excision (a second surgery to remove more tissue around the original site) or a sentinel node procedure
• People with no other solid cancers that have spread to distant parts of the body, no blood cancers, and no cancers requiring systemic (whole-body) treatment in the past 6 months
• People who have not previously received certain types of immunotherapy (those targeting CTLA-4, PD-1, PD-L1, or LAG-3)
• People who have not previously received targeted cancer treatments known as BRAF/MEK inhibitors
• People who have not used immune-suppressing medications in the past 6 months (low-dose steroids equivalent to 10mg or less of prednisolone per day are permitted)
• People whose blood test results fall within specific ranges for blood cell counts, kidney function, liver function, and other markers (confirm specific values with trial site)
• People whose LDH level (a marker measured in blood) is within the normal range
• Women who are able to become pregnant and who agree to use a highly effective form of contraception (less than 1% failure rate when used correctly) for 23 weeks after the last treatment infusion
• People who are willing and able to understand and follow the study requirements, including attending scheduled visits, completing electronic health questionnaires, having tumour biopsies taken, and giving additional blood samples

Who may not be able to join:

• People whose melanoma is of a specific subtype: acral (on palms or soles), uveal/ocular (in the eye), mucosal (on internal surfaces), or lentigo maligna melanoma
• People who have a second, separate primary melanoma at the same time
• People whose melanoma has already spread to nearby or distant areas of the body, including in-transit spread or visibly enlarged lymph nodes
• People in whom no suspicious lymph nodes can be detected by ultrasound in the relevant drainage area
• People with an active autoimmune disease, a documented history of autoimmune disease, or a history of a condition that required long-term steroids or immune-suppressing treatment (some exceptions apply — confirm with trial site)
• People who have previously had surgery, including a sentinel node procedure or lymph node removal, in the affected lymph node region
• People who have previously had radiotherapy targeting the affected lymph node region
• People with an active hepatitis B or hepatitis C infection (people fully treated for hepatitis C and clear of infection for at least one year may still be eligible — confirm with trial site)
• People with a known history of HIV or AIDS
• People with a known allergy to the study drug components, or a history of severe allergic reactions to monoclonal antibody treatments
• People with underlying health conditions or active infections that, in the treating doctor's opinion, would make the study treatment unsafe or make it difficult to assess side effects
• Women who are pregnant or breastfeeding
• People who currently need immune-suppressing medications, or who require corticosteroids at a dose above the equivalent of 10mg prednisolone daily
• People who have used another experimental drug within 30 days (or within 5 half-lives of that drug) before joining the study
• People whose personal, psychological, family, social, or geographical circumstances may make it difficult to follow the study schedule and requirements (this is assessed and discussed before registration)

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