Mucosal Melanoma of the Head and NeckPhase 2NCT07614828
Exploratory Clinical Study of Neoadjuvant Immunotherapy Combined With Chemotherapy in Malignant Melanoma of Nasal and Paranasal Mucosa
A Phase 2 study testing neoadjuvant immunotherapy combing radiochemotherapy before Endoscopic Surgery in people with Mucosal Melanoma of the Head and Neck, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
Sinonasal mucosal malignant melanoma (SNMM) is a nasal and paranasal sinus malignancy with a low incidence and extremely poor prognosis, exhibiting specificity in Asian populations. For resectable SNMM, the efficacy of neoadjuvant immunotherapy is unclear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mucosal Melanoma of the Head and Neck
- What is being tested?
- neoadjuvant immunotherapy combing radiochemotherapy before Endoscopic Surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 30 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathologically confirmed diagnosis of malignant melanoma of the nasal cavity and paranasal sinuses.
- T stage of T3 or T4a.
- Age ≥18 years.
- No distant metastasis.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, with general condition tolerating chemotherapy and general anesthesia for surgery.
- Locally resectable with curative intent, and able to undergo contrast-enhanced CT or contrast-enhanced MRI examinations.
- Adequate organ function: Hematology: white blood cells ≥3.0 × 10^9/L; absolute neutrophil count ≥1.5 × 10^9/L; hemoglobin ≥80 g/L; platelets ≥100 × 10^9/L. Hepatic function: total bilirubin ≤1.5 × upper limit of normal (ULN); AST and ALT ≤3 × ULN. Coagulation: international normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤1.5 × ULN. Renal function: serum creatinine ≤1.5 × ULN.
- Patients with recurrence after prior curative surgery are allowed; for recurrent patients, chemotherapy and immune therapy must have been discontinued for more than 6 months.
Who cannot join
- Patients who refuse to sign the informed consent form.
- Patients with uncontrolled comorbidities that, in the investigator's judgment, would interfere with treatment.
- Patients currently suffering from another malignant tumor or with synchronous multiple primary tumors that require treatment.
- Patients with surgical contraindications, such as severe cardiopulmonary disease or coagulation disorders.
- Patients with autoimmune diseases.
- Patients currently using immunosuppressants, or receiving systemic glucocorticoids for immunosuppressive purposes (dose >10 mg/day prednisone or equivalent), and who continue to use them within 2 weeks prior to first dosing.
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- Prior treatment with PD-1 monoclonal antibodies or PD-L1 monoclonal antibodies; or a history of severe allergic reactions to other monoclonal antibodies.
- Receipt of a live vaccine within 6 weeks prior to first dosing, or the possibility of receiving a live vaccine during the study.
- Any condition that may compromise protocol adherence or safety during the study.
- Uncontrolled active infection.
- Pregnant or breastfeeding women.
- Any other condition deemed unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Sinonasal mucosal malignant melanoma (SNMM) is a nasal and paranasal sinus malignancy with a low incidence and extremely poor prognosis, exhibiting specificity in Asian populations. For resectable SNMM, the efficacy of neoadjuvant immunotherapy is unclear. This prospective clinical study aims to explore the survival prognosis of neoadjuvant immunotherapy combing radiochemotherapy after Endoscopic Surgery for resectable SNMM.
- Conditions
- Mucosal Melanoma of the Head and Neck
- Being tested
- neoadjuvant immunotherapy combing radiochemotherapy before Endoscopic Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant immunotherapy combing radiochemotherapy before Endoscopic SurgeryDrug
neoadjuvant immunotherapy(Toripalimab ) combine with radiotherapy and concurrent chemotherapy(Temozolomide) before Endoscopic Surgery
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvant immunotherapy combing radiochemotherapy before Endoscopic Surgery | Experimental | Not described Receives: Drug: neoadjuvant immunotherapy combing radiochemotherapy before Endoscopic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distant Metastasis-Free Survival (DMFS)
the time from sign informed consent to the first documentation of distant metastatic recurrence or death from any cause, whichever occurs first.
Measured: from sign informed consent to 24 months, assessed every 4-8week during treatment, 12 weeks in year 1 and every 24 weeks thereafter.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Jun 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Why it stopped: no participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucosal Melanoma of the Head and NeckStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Huadong Hospital
- Responsible party
- Principal investigator, Hongmeng Yu, Eye & ENT Hospital of Fudan University
- Investigators
- Hongmeng Yu, Principal investigator, Eye & ENT Hospital,Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614828
- Sponsor's protocol ID
- SNMM-Neo-V1
- Status last verified
- Jun 2025
- First submitted
- 22 May 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Study of Neoadjuvant Immunotherapy Combined With Chemotherapy in Malignant Melanoma of Nasal and Paranasal Mucosa
- ClinicalTrials.gov ID
- NCT07614828
- Acronym / sponsor ID
- SNMM-Neo-V1
- Conditions
- Mucosal Melanoma of the Head and Neck
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Huadong Hospital
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 29 May 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.
Sinonasal mucosal malignant melanoma (SNMM) is a nasal and paranasal sinus malignancy with a low incidence and extremely poor prognosis, exhibiting specificity in Asian populations. For resectable SNMM, the efficacy of neoadjuvant immunotherapy is unclear. This prospective clinical study aims to explore the survival prognosis of neoadjuvant immunotherapy combing radiochemotherapy after Endoscopic Surgery for resectable SNMM.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant immunotherapy combing radiochemotherapy before Endoscopic Surgery | Experimental | Drug: neoadjuvant immunotherapy combing radiochemotherapy before Endoscopic Surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histopathologically confirmed diagnosis of malignant melanoma of the nasal cavity and paranasal sinuses.
- T stage of T3 or T4a.
- Age ≥18 years.
- No distant metastasis.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, with general condition tolerating chemotherapy and general anesthesia for surgery.
Key exclusion criteria (12 listed)
- Patients who refuse to sign the informed consent form.
- Patients with uncontrolled comorbidities that, in the investigator's judgment, would interfere with treatment.
- Patients currently suffering from another malignant tumor or with synchronous multiple primary tumors that require treatment.
- Patients with surgical contraindications, such as severe cardiopulmonary disease or coagulation disorders.
- Patients with autoimmune diseases.
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 |
|---|---|---|
| neoadjuvant immunotherapy combing radiochemotherapy before Endoscopic Surgeryneoadjuvant immunotherapy(Toripalimab ) combine with radiotherapy and concurrent chemotherapy(Temozolomide) before Endoscopic Surgery | Drug | neoadjuvant immunotherapy combing radiochemotherapy before Endoscopic Surgery |
Primary outcome
Distant Metastasis-Free Survival (DMFS)
Time frame: from sign informed consent to 24 months, assessed every 4-8week during treatment, 12 weeks in year 1 and every 24 weeks thereafter.
the time from sign informed consent to the first documentation of distant metastatic recurrence or death from any cause, whichever occurs first.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
Hongmeng Yu principal investigator
Eye & ENT Hospital,Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing neoadjuvant immunotherapy combing radiochemotherapy before Endoscopic Surgery in people with Mucosal Melanoma of the Head and Neck, run by Eye & ENT Hospital of Fudan University at 1 site in China.
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 8 inclusion and 12 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: withdrawn, as of the sponsor's last update on 10 Jul 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distant Metastasis-Free Survival (DMFS) (time frame: from sign informed consent to 24 months, assessed every 4-8week during treatment, 12 weeks in year 1 and every 24 weeks thereafter.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2026.