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)

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University0 个研究点目标入组 30 人开始时间: 2026年1月1日最近更新: 2026年1月20日

概览

阶段: 2 期
状态: 尚未招募
发起方: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
入组人数: 30

概览研究设计入排标准研究者记录与标识符相似试验

概览

简要总结

This study aims to conduct a prospective clinical trial investigating the use of pucotenlimab in combination with lenvatinib and temozolomide as neoadjuvant and postoperative adjuvant therapy for resectable oral and head and neck mucosal melanoma. The primary objectives are to evaluate the safety and efficacy of this combination regimen in the neoadjuvant treatment of head and neck mucosal melanoma.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age 18 to 75 years, regardless of gender.
•Histologically confirmed primary, resectable Head and Neck Mucosal Melanoma (HNMM), with measurable lesions (spiral CT scan ≥10 mm, meeting RECIST 1.1 criteria) or intraoral patch lesions deemed evaluable by the study investigators.
•ECOG performance status of 0 or
•Life expectancy ≥12 weeks.
•At least one measurable lesion according to RECIST 1.1 criteria. Previously treated lesions can also serve as target lesions if disease progression has occurred.
•Availability of tumor tissue for PD-L1 testing (paraffin-embedded specimens from within the last 2 years or fresh tumor tissue).
•Organ function must meet the following requirements (within 14 days prior to the first dose of the study drug):
•\*\*Bone Marrow:\*\* Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L, platelet count (PLT) ≥100 × 10⁹/L, hemoglobin (HB) ≥9 g/dL (no blood transfusion or blood product administration within 14 days prior to testing).
•\*\*Liver:\*\* Serum total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN (if liver metastases are present, AST and ALT ≤5 × ULN are permitted).
•\*\*Kidneys:\*\* Serum creatinine ≤1.5 × ULN or creatinine clearance ≥60 mL/min, blood urea nitrogen ≤200 mg/L.

排除标准

•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).
•Allergy to recombinant humanized anti-PD-1 monoclonal antibody or its components.
•Cutaneous melanoma, ocular melanoma, or melanoma of unknown primary origin.
•Primary lesion cannot be completely resected; presence of distant metastases; or local lesions are not indicated for surgery.
•Concurrently receiving any other anti-tumor therapy.
•Pregnancy, lactation, or women of childbearing potential not using contraception.
•Uncontrolled severe acute infection.
•Presence of any uncontrolled clinical condition, including but not limited to:
•Persistent or active (severe) infection;
•Poorly controlled diabetes;

研究者

发起方

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

申办方类型

Other

责任方

Sponsor

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