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 aged 18 or older.
• People who are willing and able to give signed consent to participate.
• People who are generally well enough to carry out daily activities with little to no limitation (as measured by a standard medical scale called ECOG, with a score of 0 or 1).
• People who have been diagnosed through laboratory testing with a specific type of skin melanoma at a moderate-to-high risk stage (stage IIb or IIc), where the tumour is either thicker than 2.0 mm with ulceration (skin breakdown) or thicker than 4.0 mm without ulceration, and the tumour is at least 5 mm wide and was not fully removed during the initial biopsy.
• People who are planned to have surgery to remove the tumour with a wide margin of surrounding tissue, along with a sentinel lymph node biopsy (a procedure to check nearby lymph nodes).
• People whose blood test results show the heart, liver, kidneys, and other organs are functioning adequately.
• Women who could become pregnant must have a negative pregnancy test taken within 72 hours before the first treatment dose.
• Women who could become pregnant must be willing to use a reliable method of contraception throughout the study and for 150 days after the last dose of study treatment (abstinence is accepted if that is their usual and preferred approach).
• Men who could father a child must be willing to use a reliable method of contraception from the first dose through to 150 days after the last dose of study treatment (abstinence is accepted if that is their usual and preferred approach).

Who may not be able to join:

• People with a life expectancy of less than 3 years.
• People who are unable to have general anaesthesia for any reason.
• People who have signs — either through physical examination or medical imaging — that the melanoma has spread to lymph nodes, nearby skin areas, or other parts of the body.
• People where, in the opinion of the study doctor, the study procedures could put them at risk of developing a cancer that cannot be surgically treated.
• People who have previously received immunotherapy treatment for any type of cancer.
• People who have received a live vaccine within four weeks before or after the last study treatment.
• People with a history of severe reactions to a type of medication called monoclonal antibodies.
• People with an active autoimmune disease, or a history of autoimmune disease that required systemic treatment (treatment affecting the whole body) — although conditions such as type 2 diabetes, rheumatoid arthritis, psoriasis, eczema, and an underactive thyroid are exceptions to this rule (confirm with trial site).
• People currently taking high-dose corticosteroids (equivalent to more than 10 mg of prednisone per day) or other medications that suppress the immune system, within 14 days before starting the study drug — although inhaled or topical steroids and low-dose replacement steroids are permitted in certain circumstances (confirm with trial site).
• People currently receiving any other cancer treatment, any other medications that suppress the immune system, or any other experimental treatment at the same time.
• People who have another known cancer that is currently growing or requires active treatment.
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the study period and for 150 days after the last dose.
• People who have any other health condition, treatment history, or abnormal test result that the treating doctor believes could interfere with the study results or would not be in the person's best interest (confirm with trial site).

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