New combo therapy aims to fight rare nasal cancer before surgery
NCT ID NCT07614828
First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether giving immunotherapy (Toripalimab) and chemotherapy (Temozolomide) before surgery can improve outcomes for people with a rare type of melanoma in the nasal cavity. The study will enroll 25 participants with resectable tumors. The main goal is to see if this approach can delay or prevent the cancer from spreading to other parts of the body.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Toripalimab (immunotherapy) and Temozolomide (chemotherapy)
- What this could lead to
- If successful, this approach could improve survival and reduce cancer spread in people with a rare and aggressive nasal melanoma.
- What could go wrong
- This is a small, early-phase trial with only 25 participants, so results may not apply broadly. The combination of treatments may cause significant side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Started
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Jun 2023
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Eye & ENT Hospital
Shanghai, Shanghai Municipality, 200030, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.