Early Phase 1 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 between 18 and 75 years of age, of any gender, who are willing to take part and sign a consent form.
• People whose melanoma has been confirmed by a tissue or cell sample (biopsy) to be either stage III or a specific type of resectable (surgically removable) stage IV.
• Stage III means the cancer has spread to at least one nearby lymph node that can be felt or seen, or has spread along the skin (called in-transit metastasis).
• Resectable stage IV means there is a single distant spread of the cancer that can be completely removed by surgery — not including brain metastases or any spread that cannot be fully removed.
• People whose melanoma did not start in the mucous membranes (such as the mouth or nasal passages) or in the eye, and whose melanoma has a known primary origin.
• People who have not received certain cancer treatments — including PD-1, PD-L1, PD-L2, or anti-CTLA4 antibody therapies, interferon, targeted therapy, radiotherapy, or systemic chemotherapy — in the past month.
• People with an expected survival of at least 6 months.
• People who have at least one tumour that can be measured using standard imaging criteria (confirm with trial site).
• People who are generally well enough to carry out light activity and care for themselves — described by doctors as having an ECOG performance score of 0 or 1 (confirm with trial site).
• People whose blood counts, kidney function, liver function, and blood clotting levels fall within acceptable ranges on recent blood tests (within 4 weeks before starting treatment) — the trial site will assess these results.
• Women who could become pregnant must have a negative pregnancy test (urine or blood) within 7 days before the first dose.
• Women enrolled in the study must be willing to use suitable contraception until 12 months after the last dose.

Who may not be able to join:

• People who are currently in, or have taken part in, another clinical drug or medical device trial within the 4 weeks before the first dose.
• People who have received any anti-cancer treatment in the past month, including chemotherapy, radiotherapy, or immunotherapy.
• People who have taken high-dose steroid medications (above 10 mg/day of prednisone or equivalent) or other immune-suppressing medications within 2 weeks before the first dose.
• People with a known history of blood cancers, primary brain tumours, sarcomas, or another primary solid cancer — unless they have been considered cured with no sign of return for at least 5 years (exceptions may apply for certain cured skin or cervical conditions — confirm with trial site).
• People with known cancer spread to the brain or the lining around the brain and spinal cord.
• People with a history of a severe allergic reaction to a monoclonal antibody treatment (a type of targeted therapy).
• People who have had an active autoimmune disease (where the immune system attacks the body) requiring ongoing systemic treatment within the past 2 years — with some exceptions such as vitiligo, type 1 diabetes, and childhood asthma (confirm with trial site).
• People with serious, uncontrolled ongoing health conditions, including active serious infections, uncontrolled diabetes, certain heart conditions, recent heart attack or stroke, serious lung disease, HIV, active hepatitis C, active hepatitis B with detectable virus in the blood, or a history of tuberculosis.
• People who have received a live vaccine within 4 weeks before the first dose, certain blood-stimulating medications within 2 weeks before the first dose, or had major surgery within 2 weeks before the first dose.
• People with a known psychiatric condition or substance use disorder that would make it difficult to follow the trial requirements.
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the study.
• People with any other serious medical condition or abnormal test result that, in the trial doctor's judgement, could increase the risks of participation or affect the trial results.

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