Combining Toripalimab with Radiotherapy and Chemotherapy for Sinonasal Melanoma Treatment

Phase II, Single-arm, Prospective Clinical Study of Toripalimab Combined With Radiotherapy and Chemotherapy in the Treatment of Sinonasal Malignant Mucosal Melanoma（SNMM） After Endoscopic Surgery

This study is testing if combining a new drug called Toripalimab with radiation and chemotherapy can help people with sinonasal melanoma after surgery feel better and improve their outcomes.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Eye & ENT Hospital of Fudan University (other)
• Drugs / interventions: radiation, prednisone, Toripalimab, chemotherapy
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT04879654 on ClinicalTrials.gov

What this trial studies

This Phase II clinical trial investigates the effectiveness of Toripalimab, a PD-1 antibody, in conjunction with radiotherapy and chemotherapy for patients with sinonasal malignant mucosal melanoma following endoscopic surgery. The study is designed as a single-arm, prospective trial, focusing on patients with locally resectable tumors classified as T3 and T4. Participants will undergo treatment to assess the safety and efficacy of this combined approach in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with pathologically diagnosed sinonasal malignant mucosal melanoma that is locally resectable and has not metastasized.

Not a fit: Patients with distant metastasis, uncontrolled diseases, or those who have had prior head and neck radiation or systemic anti-tumor therapy in the last five years may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with sinonasal malignant mucosal melanoma, potentially improving survival rates and quality of life.

How similar studies have performed: While there have been studies exploring PD-1 inhibitors in melanoma, the specific combination of Toripalimab with radiotherapy and chemotherapy in sinonasal melanoma is relatively novel.

Eligibility criteria

Inclusion Criteria:

1.Pathologically diagnosed as sinonasal malignant mucosal melanoma, locally resectable and no contraindication for surgery or radiation. 2.T3 and T4. 3.Age ≥18 year-old 4.No distant metastasis 5.No head and neck radiation and systemic anti-tumor therapy performed in the past 5 years. 6.The performance status of the Eastern Cooperative Oncology Group(ECOG) is 0-2 points and surgery after general anesthesia and postoperative radiation could be tolerated. 7.Accepted organ function

Exclusion Criteria:

1. Patients who refused to sign informed consent. 2. Have received radioactive seed implantation in the treatment area. 3. Suffer from uncontrolled disease which could interfere treatment. 4. Suffered from another malignant tumor or multiple primary tumors at the same time within 5 years (excluding fully treated basal cell or squamous cell skin cancer, cervical cancer in situ, etc.). 5. The patient has surgical contraindications: such as severe cardiopulmonary disease, coagulation dysfunction and so on. 6.The patients have autoimmune diseases. 7. The patient is using immunosuppressive agents or systemic hormone therapy to achieve the purpose of immunosuppression (dose\>10mg/day prednisone or other curative hormones), and continues to use it within 2 weeks before the first administration; 8. Severe allergic reaction to other monoclonal antibodies; 9. Previously received PD-1 monoclonal antibody, CTLA-4 monoclonal antibody (or any other antibody that acts on T cell co-stimulation or checkpoint pathway) treatment; 10. Live vaccines have been inoculated within 4 weeks before the first administration or during the study period; 11. The patient has any situation that may hinder study compliance or the safety during the study period.12. Existence of serious neurological or psychiatric diseases, such as dementia and seizures; 13. Uncontrolled active infection. 14. Pregnant or breastfeeding women. 15. Those who have no personal freedom and independent capacity for civil conduct;p. 16. There are other situations that are not suitable for entry into the study.

Where this trial is running

Shanghai, Shanghai

• Eye& ENT Hospital, Fudan University — Shanghai, Shanghai, China (RECRUITING)

Study contacts

• Principal investigator: Hongmeng Yu, MD,PHD — Eye&ENT Hospital,Fudan University
• Study coordinator: Xiaole Song, MD

Conditions: Malignant Melanoma, Sinonasal Melanoma