NCT07209189

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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
• HPV 16 Positive Oropharyngeal Tumors (OPC)

Interventions

Type	Name	Description
DRUG	Toripalimab + Chemotherapy	Toripalimab is the study drug and will be given via IV in all arms except "Rad+/-Chem : Adjuvant radiation or chemoradiotherapy"
DRUG	Toripalimab	Study drug
RADIATION	Chemoradiotherapy or radiation	In the adjuvant phase, either radiation or chemoradiotherapy is used for treatment

Timeline

• Start date: 2026-03-04
• Primary completion: 2030-10-01
• Completion: 2030-12-01
• First posted: 2025-10-06
• Last updated: 2026-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study