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

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.

NCT Number	NCT07209189
Lead Sponsor	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Collaborators: Coherus Oncology, Inc.
Conditions	Head and Neck Cancer, Squamous Cell Carcinoma, Oral Cavity Cancer, Oropharyngeal Cancer, Laryngeal Cancer, Sinonasal Squamous Cell Carcinoma, HPV (Human Papillomavirus)-Associated Carcinoma, Skull Base Tumors +1 more
Enrollment	75 participants
Start Date	2026-02-18
Primary Completion	2030-10-01 (estimated)
Study Completion	2030-12-01 (estimated)
Updated on ClinicalTrials.gov	2026-04-23