drugset / Trial / NCT07209189

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

NCT07209189 ↗

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The NeoScorch HN study is a single institution multisite phase II trial including 3 cohorts of 25 patients each for patients with newly diagnosed locoregionally advanced, histologically confirmed, head and neck cancer eligible for curative-intent treatment, who will receive neo-adjuvant chemoimmunotherapy-based treatment as well as standard of care adjuvant treatment. The three cohorts include three different aspects of surgical de-escalation in head and neck cancer. The first cohort includes human papillomavirus independent (HPV-) squamous cell carcinoma of the head and neck. The second cohort includes HPV-associated head and neck cancer with radiographic evidence of extranodal extension in neck lymphadenopathy. The third cohort specifically includes malignancies of the sinonasal cavity and skull base which have a propensity for invasion of the orbit, skull base, and maxilla. Surgical treatment of all three of these cohorts has significant morbidity including swallowing, speech, and vision among others.

Timeline

Start
2026-02-18
Primary completion
2030-10-01
Completion
2030-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Toripalimab Monoclonal antibody — Intravenous
Background Carboplatin Small molecule — —
Background Cisplatin Other / unclassified — —
Background Docetaxel Small molecule — —