NCT06940180

Toripalimab With Chemotherapy for Sinus Cancer

Perioperative Chemoimmunotherapy With Toripalimab for Sinonasal Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Glenn J. Hanna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this research study is to evaluate the effectiveness and safety of a combination of immunotherapy, using a drug called toripalimab, with chemotherapy drugs, Carboplatin and Docetaxel, as a possible treatment before surgery for sinonasal cancers. The names of the study drugs used in this research study are: * Toripalimab (a type of monoclonal antibody) * Carboplatin (a type of antineoplastic agent) * Docetaxel (a type of antineoplastic agent) * Cisplatin (a type of antineoplastic agent)

Detailed description

This single-arm, open-label, single-center phase II study is to evaluate the effectiveness and safety of a combination of immunotherapy, using a drug called toripalimab with chemotherapy drugs, Carboplatin and Docetaxel, as a possible treatment before surgery for sinonasal cancers. Toripalimab binds to the PD-1 receptors on T-cells (immune cells) and prevents them from interacting with PD-L1 and PD-L2 on tumor cells. This stimulates the immune system to fight tumor cells. The U.S. Food and Drug Administration (FDA) has not approved Toripalimab for sinonasal cancers, but it has been approved for another type of head and neck cancer called nasopharyngeal carcinoma (NPC), in the advanced incurable setting when surgery is no longer possible, or when cancer has spread to parts of the body outside the head and neck region. Carboplatin and Docetaxel have been approved by the FDA in the advanced incurable setting for other types of head and neck cancer. The research study procedures include screening for eligibility, in-clinic visits, questionnaires, blood tests, urine tests, X-rays, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, or Positron Emission (PET) scans, and photographic images of tumors. It is expected that about 20 people will take part in this research study. Coherus Biosciences, a pharmaceutical company, is funding this research study by providing the study drug and funding for the research study.

Conditions

• Sinonasal Cancer
• Paranasal Sinus Neoplasms
• Squamous Cell Carcinoma
• Sinonasal Undifferentiated Carcinoma
• Locally Advanced Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Toripalimab	An anti-PD-1 monoclonal antibody, single-use vial, via intravenous (into the vein) infusion per protocol.
DRUG	Carboplatin	An antineoplastic agent, multi-dose vials, via intravenous (into the vein) infusion per standard of care.
DRUG	Docetaxel	A taxoid antineoplastic agent, single-dose vials, via intravenous (into the vein) infusion per standard of care.
RADIATION	Radiation Therapy	per standard of care
DRUG	Cisplatin	An antineoplastic agent, single-dose vials, via intravenous (into the vein) infusion per standard of care.

Timeline

• Start date: 2025-06-17
• Primary completion: 2028-02-01
• Completion: 2029-02-01
• First posted: 2025-04-23
• Last updated: 2025-06-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study