Au-TMP and Radiotherapy for Advanced Melanoma With Anti-PD-1 Therapy

Exclusion Criteria20

• Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents.
• Known hypersensitivity to recombinant humanized anti-PD-1 monoclonal antibodies or any of their components.
• Active skin breakdown, infection, ulceration, necrosis, bleeding at the injection site, or a high risk of hollow organ perforation.
• Known allergy or intolerance to Au-TMP active ingredients, excipients, or similar compounds.
• Presence of known driver mutations (e.g., BRAF V600E/K, c-KIT, NRAS) for which targeted therapies are already approved and available as first-line treatment.
• Ocular (uveal) or mucosal melanoma.
• Receipt of other anti-tumor therapies (including corticosteroids or immunotherapy) or participation in other clinical trials within 4 weeks before treatment initiation; failure to recover from toxicities of prior therapies (except Grade 2 alopecia and Grade 1 neurotoxicity).
• Pregnant or breastfeeding women.
• Positive for Human Immunodeficiency Virus (HIV) or Hepatitis C Virus (HCV). Patients with positive Hepatitis B Surface Antigen (HBsAg) or Hepatitis B Core Antibody (HBcAb) must have a negative Hepatitis B Virus (HBV) DNA test (quantitative detection < 500 IU/mL).
• History of active tuberculosis.
• Active autoimmune disease requiring systemic treatment within the past 2 years (except physiological replacement therapy for thyroid, insulin, or adrenal/pituitary insufficiency).
• Serious uncontrolled concurrent medical conditions, including uncontrolled diabetes, interstitial lung disease, New York Heart Association (NYHA) Class III/IV heart failure, severe cardiac arrhythmias, or recent (within 6 months) myocardial infarction or cerebrovascular accidents.
• Active Central Nervous System (CNS) or leptomeningeal metastases. Patients with treated brain metastases are eligible if they are stable (no progression via Magnetic Resonance Imaging (MRI)) for at least 8 weeks post-treatment and 28 days prior to the first dose, and do not require immunosuppressive doses of corticosteroids (>10 mg/day prednisone equivalent) for at least 2 weeks.
• Receipt of hematopoietic stimulants (e.g., G-CSF, EPO) within 2 weeks prior to treatment.
• Receipt of live vaccines within 4 weeks prior to treatment.
• Major surgery (excluding diagnostic procedures) within 4 weeks prior to treatment.
• History of psychiatric disorders or persistent drug/substance abuse.
• Other malignancies within the past 5 years, except for successfully treated localized cancers such as basal/squamous cell skin cancer or in situ carcinomas (cervix, breast, prostate).
• Any other acute or chronic medical/psychiatric condition or laboratory abnormality that, in the investigator's opinion, increases research-related risk or interferes with the interpretation of study results.
• Any condition that is not in the best interest of the participant.