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:

• Adults aged 18 or older
• People who are able to give written agreement to participate, following all the study rules and requirements
• People with a good general health and activity level, rated 0 or 1 on the WHO Performance Status scale (meaning fully active or able to carry out light work) (confirm with trial site)
• People who have been diagnosed with Stage III melanoma that has been confirmed through a tissue or cell sample, including cases where the cancer has spread in small lumps near the original site (called in-transit metastases), as long as there are 3 or fewer of these and they can be surgically removed
• People whose melanoma started on the skin, on the hands or feet (acral), or whose original melanoma site is unknown
• People whose tumours can be completely removed by surgery with clear margins and without involving major blood vessels, nerves, or bone
• Women who could potentially become pregnant must have a negative pregnancy test (urine or blood) within 72 hours before starting treatment
• Women who could potentially become pregnant must agree to use a highly effective form of contraception during the study and for 150 days after the last dose — acceptable methods include a vasectomised sole partner, hormonal contraception (pill, patch, implant, injection, or vaginal ring), a hormone-releasing intrauterine system, or an intrauterine device (IUD) with a failure rate below 1%; abstinence is acceptable if it is the person's usual and preferred approach
• Men who could father a child must agree to use adequate contraception from the first dose until 150 days after the last dose; their female partner must either be post-menopausal, permanently sterilised, or use a highly effective contraceptive method; abstinence is acceptable if it is the person's usual and preferred approach
• People who have not previously had another cancer, or who have been treated for another cancer with the aim of a cure and whose life expectancy related to that cancer is more than 5 years
• People who have not previously received immunotherapy that targets CTLA-4, PD-1, or PD-L1
• People who have not previously received targeted therapy aimed at BRAF and/or MEK

Who may not be able to join:

• People whose melanoma cannot be surgically removed
• People with uveal (eye) or mucosal (lining of internal organs) melanoma
• People with serious or uncontrolled medical conditions that, in the investigator's opinion, could make participation risky, affect the ability to receive the study treatment, or affect the reliability of results
• People who need regular systemic treatment with corticosteroids at a dose higher than the equivalent of 10 mg of prednisone per day, or other medications that suppress the immune system, within 14 days before starting the study drug (inhaled or topical steroids and certain replacement-level doses are permitted in some circumstances — confirm with trial site)
• Women who are currently pregnant or breastfeeding
• People with any condition that may make it difficult to follow the study schedule or protocol requirements (confirm with trial site)

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