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
Massachusetts General Hospital
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).
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 stud…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants must have a new diagnosis of histologically or cytologically confirmed squamous cell carcinoma (SCC) of the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, sinonasal cavities or unknown primary HNSCC. * Participants with HPV-independent SCC or HNSCC or other head and neck subsites must have stage III or non-metastatic stage IV at the time of diagnosis. Participants with HPV-associated oropharynx SCC must have stage II or stage III disease. * Participants must be determined by the investigator to be candidates for induction systemic therapy due to…
Interventions
- DrugToripalimab-tpzi
Toripalimab-tpzi is a humanized IgG4 monoclonal antibody specific against human PD-1.
- DrugCisplatin
Cisplatin is an injectable chemotherapy agent classified as a platinum-based alkylating agent.
- DrugDocetaxel
Docetaxel is a taxane chemotherapy agent.
Locations (2)
- Massachusetts General HospitalBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts