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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.
Details
| Lead sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
|---|---|
| Phase | PHASE2 |
| Status | RECRUITING |
| Enrolment | 75 |
| Start date | Wed Mar 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Sun Dec 01 2030 00:00:00 GMT+0000 (Coordinated Universal Time) |
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
- Toripalimab + Chemotherapy
- Toripalimab
- Chemoradiotherapy or radiation
Countries
United States