A Prospective, Single-Arm, Phase II Clinical Study of Neoadjuvant Therapy With Pucotenlimab, Lenvatinib, and Temozolomide for Resectable Head and Neck Mucosal Melanoma (PLT-NAT-HNMM-II)

Exclusion Criteria

• •1. Prior treatment with PD-1/PD-L1/PD-L2/CTLA-4 antibodies, or drugs targeting T-cell receptor activation or inhibition (e.g., OX40, CD137).
• •2. Allergy to recombinant humanized anti-PD-1 monoclonal antibody or its components.
• •3. Cutaneous melanoma, ocular melanoma, or melanoma of unknown primary origin.
• •4. Primary lesion cannot be completely resected; presence of distant metastases; or local lesions are not indicated for surgery.
• •5. Concurrently receiving any other anti-tumor therapy.
• •6. Pregnancy, lactation, or women of childbearing potential not using contraception.
• •7. Uncontrolled severe acute infection.
• •8. Presence of any uncontrolled clinical condition, including but not limited to:
• •* Persistent or active (severe) infection;
• •* Poorly controlled diabetes;
• •* Cardiac disease (NYHA Class III/IV congestive heart failure or heart block);
• •* Current or suspected autoimmune disease, or history of autoimmune disease or syndromes requiring systemic steroid/immunosuppressant therapy, such as hypophysitis, colitis, hepatitis, nephritis, hyperthyroidism, hypothyroidism, etc.;
• •* Occurrence of any of the following within 6 months prior to the first dose: deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmia or angina; percutaneous coronary intervention, acute coronary syndrome, or coronary artery bypass graft; cerebrovascular accident, transient ischemic attack, or cerebral embolism.
• •9. Patients with active hepatitis B or C:
• •* If HBsAg or HBcAb is positive, HBV DNA must be tested (excluded if above the upper limit of normal).
• •* If HCV antibody is positive, HCV RNA must be tested (excluded if above the upper limit of normal).
• •10. Occurrence of any of the following within 6 months prior to the first dose: deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmia or angina; percutaneous coronary intervention, acute coronary syndrome, or coronary artery bypass graft; cerebrovascular accident, transient ischemic attack, or cerebral embolism.
• •11. Any other severe, acute, or chronic medical condition or laboratory abnormality that, in the investigator's judgment, may increase study-related risk or potentially interfere with the interpretation of study results.
• •12. History of stem cell or organ transplantation.
• •13. History of psychoactive drug abuse with inability to abstain, or history of psychiatric disorders.
• •14. Patients whom the investigator judges to have poor compliance or other conditions making them unsuitable for participation in this trial.
• •15. Concurrent participation in other clinical studies, except for observational studies or those deemed non-conflicting with this study.
• •16. History of other malignancies within the past 5 years, except for cured basal cell carcinoma, squamous cell carcinoma of the skin, early-stage prostate cancer, and carcinoma in situ of the cervix.
• •17. Patients using immunosuppressants or systemic corticosteroids for immunosuppressive purposes (equivalent to \>10mg/day prednisone) and continuing such use within 2 weeks prior to enrollment.
• •18. Patients who have received hematopoietic growth factors (e.g., G-CSF, erythropoietin) within 1 week prior to the first dose of the study drug.
• •19. Any underlying medical condition that, in the investigator's opinion, would increase the risk of study drug administration or confound the assessment of toxicity or adverse events.