Not Yet RecruitingPhase 2

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)

China30 participantsStarted 2026-01-01

Plain-language summary

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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Exclusion criteria

✕. 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:

What they're measuring

Pathological Response Rate (pCR + Near-pCR + pPR).

Timeframe: Preoperatively, within 2-4 weeks after completing neoadjuvant therapy

Trial details

NCT IDNCT07353073

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Guoxin Ren M.D. the Ninth People's Hospital Affiliated to Shanghai Jiao Tong

13916948812 scjtdcq@126.com

View on ClinicalTrials.gov More Head and Neck Mucosal Melanomas trials