Phase 4 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 willing and able to attend scheduled visits, complete lab tests, and follow the study requirements.
• People diagnosed with advanced melanoma that cannot be surgically removed, classified as stage IIIB through stage IV (including certain advanced mucosal melanoma stages).
• People whose melanoma started on the skin, on acral areas (such as the palms, soles, or under nails), or in mucosal areas (such as the mouth or sinuses), or whose melanoma has no known starting point.
• People who have at least one tumour that can be measured using standard imaging guidelines.
• People who can provide tumour tissue (either stored from a previous biopsy or freshly collected) and a blood sample for a specific genetic test called Signatera.
• People who are about to begin standard first-line treatment for their advanced melanoma.
• People who have not previously received treatment for metastatic (spread) disease — though prior surgery, certain types of radiotherapy after surgery, and some completed adjuvant (preventive) treatments are allowed, provided those treatments finished at least 6 months before joining (confirm with trial site).
• People who have had full physical examinations and imaging scans (including chest, abdomen, pelvis, and brain scans) completed within 4 weeks before starting the study drug.
• People whose blood test detects circulating tumour DNA (ctDNA) — a type of cancer-related genetic material found in the bloodstream — at the start of the study.
• People with a general health performance status rated 0 or 1 on a standard scale, meaning they are fully active or have only minor restrictions on physical activity (confirm with trial site).
• People who have had or currently have a separate, non-melanoma cancer, as long as that cancer or its treatment is unlikely to affect the safety or results of this study.
• People with brain metastases that are not causing symptoms, including those who have had or will have targeted brain radiotherapy, provided they are taking less than 10 mg per day of prednisone (or equivalent) at the time of treatment.
• People whose recent blood test results meet the required levels for blood cell counts, kidney function, liver function, and clotting (confirm specific values with trial site).

Who may not be able to join:

• People whose cancer has spread to the membranes surrounding the brain and spinal cord (carcinomatous meningitis), or who have a history of melanoma originating in the eye (ocular/uveal melanoma).
• People with a history of inflammation of the heart muscle (myocarditis).
• People with an active autoimmune disease that requires immune-suppressing medication beyond a low dose of prednisone (more than 10 mg per day) — though certain manageable autoimmune conditions such as type 1 diabetes, thyroid conditions managed with hormone replacement only, or mild skin conditions not needing systemic treatment may still be eligible (confirm with trial site).
• People who are currently taking corticosteroids at more than 10 mg per day of prednisone (or equivalent), or other immune-suppressing medications, within 14 days of starting the study — though inhaled or topical steroids may be acceptable in some cases.
• People currently receiving other anti-cancer treatments at the same time as the standard treatment used in this trial — though medications for managing bone metastases (such as bisphosphonates or RANKL inhibitors) are permitted.
• People with a serious uncontrolled medical condition or active infection that, in the opinion of the study doctor, could increase risk or interfere with participation.
• People with a known allergy or sensitivity to monoclonal antibody medications.
• People who are pregnant.
• People who have already received prior treatment for melanoma, beyond the specific exceptions listed above (surgery, certain radiotherapy after surgery, or eligible adjuvant therapy completed at least 6 months prior).
• People whose recent blood test results fall outside the required ranges for blood cell counts, kidney function, or liver function — including those who have recently used blood cell growth factor medications.

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