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 cohor

Trial Details

NCT ID
NCT07209189
Phase
PHASE2
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Status
RECRUITING
Cancer Type
HPV Positive Head and Neck Cancer
Interventions
  • Toripalimab + Chemotherapy
  • Toripalimab
  • Chemoradiotherapy or radiation
Locations (sample)
  • Baltimore, Maryland, United States|39.29038,-76.61219

Key Eligibility Criteria

  • Eligible subjects must have histologically confirmed, locoregionally advanced head and neck or sinonasal, nasolacrimal, or skull base tumors and me…
  • HPV-independent HNSCC (cT2-cT4, N0-N3) with potential for organ preservation using response-adapted surgery.
  • HPV-associated HNSCC with radiographic extranodal extension (cT1-cT3 tonsil or lateralized base of tongue, N0-N1, up to 4 nodes with rENE).
  • Sinonasal/skull base tumors, including: sinonasal carcinomas, HPV-associated sinonasal cancer, sinonasal undifferentiated carcinoma (e.g., Isocitra…

For full eligibility, visit ClinicalTrials.gov.

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