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:

• People aged 18 or older.
• People whose general physical condition is rated as fully active or able to carry out light work (as measured by a standard oncology scale called ECOG, with a score of 0 or 1).
• People with a confirmed diagnosis of melanoma that cannot be surgically removed and has been classified as advanced Stage III or Stage IV, and who have not yet received systemic (whole-body) treatment for it — though previous treatment given before or after surgery is allowed, provided it finished at least 3 weeks before joining and any side effects have largely resolved.
• People who have at least one tumour that can be measured using standard imaging criteria.
• People who have at least one tumour suitable for direct injection and radiation therapy — located in the skin, tissue just under the skin, nearby lymph nodes, or internal organs considered safe to access — that has not previously been treated with radiotherapy (unless that lesion has since grown).
• People whose blood counts, kidney function, liver function, blood clotting, and heart function all meet specific healthy thresholds when tested within 7 days before starting treatment (confirm with trial site for exact values).
• People expected to live for at least 16 weeks.
• People who agree to use highly effective contraception throughout the trial and for 12 months after the last dose.
• People who are willing to participate voluntarily, sign a consent form, follow the trial instructions, and attend follow-up visits.

Who may not be able to join:

• People who have previously been treated with certain immune checkpoint drugs that target PD-1 or PD-L1/PD-L2 pathways.
• People with a known allergy to the type of antibody medication being studied or any of its ingredients.
• People who have active skin breakdown, infection, open sores, tissue death, or bleeding at the planned injection site, or where there is a high risk of puncturing a hollow organ.
• People with a known allergy or intolerance to the other study drug (Au-TMP) or similar compounds.
• People whose melanoma has a specific genetic mutation (such as BRAF V600E/K, c-KIT, or NRAS) for which an approved targeted treatment is already available as a first-line option.
• People whose melanoma originated in the eye (uveal melanoma) or in mucous membranes (mucosal melanoma).
• People who have received other anti-cancer treatments — including steroids or immunotherapy — or who have been in another clinical trial within 4 weeks before starting, or who have not yet recovered from side effects of prior treatments (with minor exceptions for certain hair loss or mild nerve-related effects).
• People who are pregnant or breastfeeding.
• People who test positive for HIV or Hepatitis C virus; people with certain Hepatitis B markers must have a sufficiently low level of the virus on testing to potentially be considered (confirm with trial site).
• People with a history of active tuberculosis.
• People who have an active autoimmune disease that has required ongoing systemic treatment within the past 2 years — with exceptions for standard hormone replacement for thyroid, insulin, or adrenal/pituitary conditions.
• People with serious uncontrolled health conditions, including uncontrolled diabetes, inflammatory lung disease, severe heart failure, serious heart rhythm problems, or a heart attack or stroke within the past 6 months.
• People with active cancer spread to the brain or the lining of the brain and spinal cord — though people whose brain metastases have been treated and have been stable for at least 8 weeks, and who do not need high-dose steroids, may potentially be considered (confirm with trial site).
• People who have received blood-stimulating medications (such as G-CSF or EPO) within 2 weeks before starting treatment.
• People who have received a live vaccine within 4 weeks before starting treatment.
• People who have had major surgery (not including minor diagnostic procedures) within 4 weeks before starting treatment.
• People with a history of psychiatric disorders or ongoing drug or substance misuse.
• People who have had another cancer within the past 5 years — with exceptions for certain successfully treated localised skin cancers or early-stage cancers of the cervix, breast, or prostate.
• People with any other medical, psychiatric, or laboratory finding that the trial investigators believe would increase risk or make it harder to interpret the trial results.
• People in any situation that the investigators consider not to be in their best interest.

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