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

Inclusion criteria

• ✓. Age: Age ≥ 18 years.
• ✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• ✓. Histologically confirmed unresectable Stage III or Stage IV melanoma without prior systemic therapy. Prior adjuvant or neoadjuvant therapy is permitted, provided it was completed at least 3 weeks before enrollment and all related adverse events (AEs) have resolved to baseline or NCI CTCAE v5.0 Grade ≤ 1.
• ✓. Presence of at least one measurable lesion according to RECIST v1.1 criteria.
• ✓. At least one lesion suitable for intratumoral injection and radiotherapy (located in the skin, subcutaneous tissue, superficial lymph nodes, or visceral lesions assessed as safe for access) that has not received prior radiotherapy (unless documented progression has occurred).
• ✓. Adequate hematologic and organ function within 7 days prior to the first dose, including:
• ✓. Anticipated survival time ≥ 16 weeks.
• ✓. Agreement to use highly effective contraception methods during the trial and for 12 months after the last dose of treatment.

Exclusion criteria