Phase II Study of Neoadjuvant Chemotherapy and PD-1 Inhibitor Toripalimab for Reducing Surgery in Advanced Head and Neck Cancers Including HPV-Associated and Sinonasal Tumors

What this Trial Is About

Researchers are evaluating neoadjuvant chemoimmunotherapy combined with standard adjuvant treatment in patients with newly diagnosed locoregionally advanced head and neck cancers, including HPV-independent and HPV-associated squamous cell carcinoma, as well as sinonasal and skull base tumors. This phase II trial aims to study surgical de-escalation approaches to reduce treatment-related morbidity affecting swallowing, speech, and vision. The study is conducted by the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins and includes three cohorts of 25 patients each with specific tumor characteristics. Participants receive neoadjuvant treatment involving Toripalimab combined with chemotherapy drugs such as Cisplatin and Docetaxel or Carboplatin and Docetaxel. After surgery, patients undergo adjuvant radiation or chemoradiotherapy as part of standard care. Following adjuvant treatment, Toripalimab is administered again. The trial investigates these treatments and surgical approaches across the three cohorts, assessing their impact on the tumors and patient outcomes. During the study, patients are monitored for major pathological response over up to 5 years. Evaluations include imaging and clinical exams to confirm eligibility and disease status, including HPV testing and measurable tumor assessment. Safety and treatment adherence are tracked through laboratory tests and clinical criteria. Participants are followed through neoadjuvant therapy, surgery, adjuvant treatment, and long-term monitoring to assess treatment effects and disease response.

Neoadjuvant Chemotherapy and Programmed Cell Death Protein 1(PD-1) Inhibition for Head and Neck Cancer Treatment De-escalation (NeoScorch HN)