Clinical Research Directory

Inclusion Criteria: * 18 years of age or older * Participants with histologically or cytologically confirmed stage 3C/3D/4M1 advanced or cutaneous metastatic melanoma, with measurable disease by standard histological methods (not iRECIST) including any number of cutaneous lesions * Present a visible and accessible primary tumor or metastatic deposit (any site) that has not been surgically removed * Present target tumors of 0.5 -2.5 cm in diameter * Participants must have received and failed (progressed) following at least one prior standard therapy, including immune checkpoint inhibitors (e.g., anti- PD1 or anti-CTLA-4). * Response is determined by clinical assessment and photo documentation. * ECOG Performance Status: 0-1 * Life expectancy: ≥6 months * Participants able and willing to provide written informed consent and comply with the trial protocol. Exclusion Criteria: * Women who are pregnant, breastfeeding, or planning to become pregnant during the study. * Women of childbearing potential must have a negative pregnancy test within 72 hours prior to enrollment and agree to use adequate contraception throughout the study * Any infection requiring systemic therapy or other concurrent medical conditions (e.g., hepatitis B, hepatitis C, HIV) that would interfere with the study * Myocardial infarction or stroke within the past 6 months, uncontrolled angina, or significant arrhythmia * Participants receiving blood thinners as part of therapeutic anticoagulation therapy * Any severe or uncontrolled comorbid condition that, in the investigator's opinion, would pose excessive risk to the participants (e.g., immunodeficiencies, severe hypertension, uncontrolled diabetes, liver failure) * Participation in another clinical trial involving an investigational product/device within 30 days prior to screening * Any condition that would impede compliance with study procedures * Participants with a known allergy to gold of any kind * Participants who are unable to tolerate cutaneous injections for any reason will not be eligible * Participants with a known allergy to injectable local analgesics * Participants with ocular melanoma or melanoma involving periorbital skin.