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Pucotenlimab, Lenvatinib, and Temozolomide Combination for Resectable Head and Neck Mucosal Melanoma

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What is being tested

Preoperatively, patients will receive 2 cycles of pucotenlimab (200 mg every 3 weeks, or 3 mg/kg every 3 weeks) combined with lenvatinib (20 mg once daily) and temozolomide (150 mg/m² orally once dail

Drug
Who is being recruted

From 18 to 75 Years
+28 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: January 2026
See protocol details

Summary

Principal SponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study ContactGuoxin Ren M.D. the Ninth People's Hospital Affiliated to Shanghai Jiao Tong
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2026

Actual date on which the first participant was enrolled.

This clinical study focuses on a specific type of skin cancer known as head and neck mucosal melanoma that can be removed through surgery. The study explores the use of a combination of drugs, namely pucotenlimab, lenvatinib, and temozolomide, before and after surgery. The main goal is to assess the safety and effectiveness of this drug combination in treating this form of melanoma. The importance of this study lies in its potential to improve treatment options for patients with this condition and to address the current challenges associated with managing resectable head and neck mucosal melanoma. Participants in this study will receive the drug combination as a neoadjuvant therapy, which means it will be administered before surgery to shrink the tumor. After the surgery, the same drug combination will be used as an adjuvant therapy to prevent the cancer from returning. The study measures the results by evaluating the pathological response rate, which includes the complete disappearance of the tumor, near-complete disappearance, partial disappearance, and no response. The potential benefits include improved treatment outcomes, while the risks are being carefully monitored as part of the study's safety evaluation.

Official TitleA 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)
NCT07353073
Principal SponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study ContactGuoxin Ren M.D. the Ninth People's Hospital Affiliated to Shanghai Jiao Tong
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

10 inclusion criteria required to participate
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 1.
Life expectancy ≥12 weeks.
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18 exclusion criteria prevent from participating
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.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Preoperatively, patients will receive 2 cycles of pucotenlimab (200 mg every 3 weeks, or 3 mg/kg every 3 weeks) combined with lenvatinib (20 mg once daily) and temozolomide (150 mg/m² orally once daily for 5 consecutive days per 28-day cycle). Postoperatively, treatment with pucotenlimab will be continued until a total of 1 year of therapy is completed.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University School of Medicine

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Recruiting soonOne Study Center