Head and Neck Mucosal MelanomasPhase 2NCT07353073

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)

A Phase 2 study testing 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 in people with Head and Neck Mucosal Melanomas, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Head and Neck Mucosal Melanomas
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
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteChina
Study dates: 1 Jan 2026to 31 Dec 2028
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.
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).

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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.
Thyroid-stimulating hormone (TSH) ≤1 × ULN (if abnormal, free T3 [FT3] and free T4 [FT4] levels should also be assessed; if FT3 and FT4 levels are normal, the patient may be enrolled).
Urine protein ≤1+; if urine protein >1+, a 24-hour urine protein collection is required, and the total amount must be ≤1 gram.
Normal cardiac function, defined as an electrocardiogram (ECG) without clinically significant abnormalities and a left ventricular ejection fraction (LVEF) >50% as shown by echocardiography.
Female subjects of childbearing potential must have a negative serum pregnancy test result prior to the first dose of the investigational drug.
Male or female subjects of childbearing potential must use highly effective contraception methods (e.g., oral contraceptives, intrauterine devices, sexual abstinence, or barrier methods combined with spermicide) throughout the entire trial period and continue contraception for 90 days after the end of treatment.
Subjects must voluntarily join the study, sign an informed consent form, demonstrate good compliance, and cooperate with follow-up.

Who cannot join

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.

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Uncontrolled severe acute infection.
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.
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).
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.
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.
History of stem cell or organ transplantation.
History of psychoactive drug abuse with inability to abstain, or history of psychiatric disorders.
Patients whom the investigator judges to have poor compliance or other conditions making them unsuitable for participation in this trial.
Concurrent participation in other clinical studies, except for observational studies or those deemed non-conflicting with this study.
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.
Patients using immunosuppressants or systemic corticosteroids for immunosuppressive purposes (equivalent to >10mg/day prednisone) and continuing such use within 2 weeks prior to enrollment.
Patients who have received hematopoietic growth factors (e.g., G-CSF, erythropoietin) within 1 week prior to the first dose of the study drug.
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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

13916948812

scjtdcq@126.com

China1 site

Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200011

Other trials in China

About this study

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.

Conditions: Head and Neck Mucosal Melanomas
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
Keywords: head and neck mucosal melanoma, pucotenlimab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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 dailDrug
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 groups in NCT07353073
Study group	Role	What they receive
pucotenlimab in combination with lenvatinib and temozolomide	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. Receives: Drug: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

Pathological Response Rate (pCR + Near-pCR + pPR).
pCR (Pathological Complete Response, no residual tumor), near-pCR (Near Pathological Complete Response, tumor residue ≤10%), pPR (Pathological Partial Response, 10% < tumor residue ≤50%), and pNR (Pathological No Response, tumor residue >50%).
Measured: Preoperatively, within 2-4 weeks after completing neoadjuvant therapy

Secondary outcomes (3)

Pathologic Complete Response (pCR) Rate
Defined as the proportion of subjects with no viable tumor cells in the postoperative resection specimen.
Measured: Preoperatively, within 2-4 weeks after completing neoadjuvant therapy
objective response rate
It refers to the proportion of patients whose tumor volume reduction, according to recognized response evaluation criteria (such as RECIST version 1.1 for solid tumors), meets predefined criteria and is maintained for a minimum required duration. This is the sum of the rates of complete response (CR) and partial response (PR).
Measured: 4-8 weeks
adverse event (AE)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical trial participant administered a medicinal product, which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the product.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202631 Dec 2028

First posted20 Jan 2026
Study start1 Jan 2026 (estimated)
Primary completion31 Dec 2027 (estimated)
Study completion31 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Head and Neck Mucosal MelanomasStudies of the same condition, open and under way.
More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07353073
Sponsor's protocol ID: SH9H-2025-T534-1
Status last verified: Dec 2025
First submitted: 13 Jan 2026
Last updated: 20 Jan 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

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

13916948812

scjtdcq@126.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Active, not recruitingPhase 1/2
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Low Dose, Reduced Frequency Nivolumab for the Treatment of Unresectable or Metastatic Cancer, AFFORD IO Trial
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Active, not recruitingPhase 2
Using Nivolumab Alone or With Cabozantinib to Prevent Mucosal Melanoma Return After Surgery
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Not yet recruitingObservational study
CLASSIFY-OMM: Multicenter Rare Disease Cohort for T-Stage Reclassification and Molecular Subtyping-Based Precision Therapy in Oral Mucosal Melanoma
Mucosal Melanoma of the Head and Neck, Oral Melanoma
RecruitingPhase 2
Axitinib and Nivolumab for the Treatment of Mucosal Melanoma
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All Head and Neck Mucosal Melanomas trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT07353073
Acronym / sponsor ID: SH9H-2025-T534-1
Conditions: Head and Neck Mucosal Melanomas
Keywords: head and neck mucosal melanoma, pucotenlimab
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 30 participants (estimated)
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
Study start: 1 Jan 2026 (estimated)
Primary completion: 31 Dec 2027 (estimated)
Study completion: 31 Dec 2028 (estimated)
First posted: 20 Jan 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
pucotenlimab in combination with lenvatinib and temozolomide	Experimental	Drug: 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 dailPreoperatively, 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

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.
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.

Key exclusion criteria (26 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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 dailPreoperatively, 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.	Drug	pucotenlimab in combination with lenvatinib and temozolomide

Primary outcome

Pathological Response Rate (pCR + Near-pCR + pPR).
Time frame: Preoperatively, within 2-4 weeks after completing neoadjuvant therapy
pCR (Pathological Complete Response, no residual tumor), near-pCR (Near Pathological Complete Response, tumor residue ≤10%), pPR (Pathological Partial Response, 10% < tumor residue ≤50%), and pNR (Pathological No Response, tumor residue >50%).

3 secondary outcomes

Pathologic Complete Response (pCR) Rate
Time frame: Preoperatively, within 2-4 weeks after completing neoadjuvant therapy
objective response rate
Time frame: 4-8 weeks
adverse event (AE)
Time frame: 1 year

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
Individual participant dataSharing planned: No

Related trials for Head and Neck Mucosal Melanomas

Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
Low Dose, Reduced Frequency Nivolumab for the Treatment of Unresectable or Metastatic Cancer, AFFORD IO Trial
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8
Active, not recruitingPhase 2
Using Nivolumab Alone or With Cabozantinib to Prevent Mucosal Melanoma Return After Surgery
Anal Melanoma, Bladder Melanoma
Not yet recruitingObservational study
CLASSIFY-OMM: Multicenter Rare Disease Cohort for T-Stage Reclassification and Molecular Subtyping-Based Precision Therapy in Oral Mucosal Melanoma
Mucosal Melanoma of the Head and Neck, Oral Melanoma
RecruitingPhase 2
Axitinib and Nivolumab for the Treatment of Mucosal Melanoma
Mucosal Melanoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

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

13916948812

scjtdcq@126.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Guoxin Ren M.D. the Ninth People's Hospital Affiliated to Shanghai Jiao Tong (13916948812, scjtdcq@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological Response Rate (pCR + Near-pCR + pPR). (time frame: Preoperatively, within 2-4 weeks after completing neoadjuvant therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07353073.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.