NCT07214987

PDT For Induction Therapy For Head And Neck Cancer

A Phase 2 Study of Toripalimab in Combination With Cisplatin and Docetaxel (PDT) for Induction Therapy in CPS-Positive Locally Advanced Head and Neck Squamous Cell Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is being done to assess the safety and tolerability of toripalimab in combination with cisplatin and docetaxel (PDT) induction therapy for patients with CPS-positive locally advanced head and neck squamous cell carcinoma (HNSCC).

Detailed description

This is a single arm phase II study to assess treatment-related adverse events (TRAEs) and efficacy of PDT. The study employs a Simon two-stage design. After 12 evaluable participants start treatment with at least 2 participants experiencing no grade 3 or higher TRAEs during induction therapy, then enrollment will continue to the target number of participants of 26. Participants will receive treatment for three cycles or until disease progression, they experience unacceptable side effects, their condition changes rendering them unacceptable for further treatment, or they withdraw from the study. Participants will be followed for two years from registration. Coherus Biosciences, Inc. is supporting this research study by providing the study drug, toripalimab, and funding for research activities. The U.S. FDA has not approved toripalimab for CPS-positive locally advanced HNSCC but has approved it for other forms of head and neck cancer. Toripalimab is a lab-made antibody that works by allowed the immune system to attack cancer cells more effectively. Toripalimab is currently sold as LOQTORZI and is used with cisplatin and gemcitabine to treat nasopharyngeal carcinoma. The U.S. FDA has approved cisplatin and docetaxel as a treatment option for multiple types of cancers, including head and neck small cell carcinoma. Cisplatin is a chemotherapy agent that works by binding to cancer cells and initiating cell death. Docetaxel is a chemotherapy agent made from a compound found in the European yew tree. Docetaxel works by stabilizing tiny structures within cancer cells, prevent cell growth and, ultimately leading to cell death. The combination of toripalimab with cisplatin and docetaxel for induction therapy is investigational.

Conditions

• Squamous Cell Carcinoma
• Head and Neck Cancer Squamous Cell Carcinoma
• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Toripalimab-tpzi	Toripalimab-tpzi is a humanized IgG4 monoclonal antibody specific against human PD-1.
DRUG	Cisplatin	Cisplatin is an injectable chemotherapy agent classified as a platinum-based alkylating agent.
DRUG	Docetaxel	Docetaxel is a taxane chemotherapy agent.

Timeline

• Start date: 2026-03-09
• Primary completion: 2027-12-31
• Completion: 2029-09-01
• First posted: 2025-10-09
• Last updated: 2026-01-30

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study