RecruitingPhase 2NCT07209189

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)


Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

75 participants

Start Date

Feb 18, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

The NeoScorch HN study tests whether giving chemotherapy plus an immunotherapy drug before surgery for head and neck cancer — and using the tumor's response to guide the extent of surgery or radiation — can reduce the aggressiveness of treatment without sacrificing outcomes. **You may be eligible if...** - You have been diagnosed with locally advanced head and neck or sinonasal cancer confirmed by biopsy - Your cancer falls into specific categories: HPV-negative head and neck squamous cell cancer, HPV16-positive cancer with specific nodal characteristics, or sinonasal/skull base tumors - You are a candidate for organ-preserving surgery based on your response to treatment **You may NOT be eligible if...** - Your cancer is HPV-positive but caused by a strain other than HPV16 - Your cancer has spread to distant organs - You have had prior radiation to the head and neck area - Your overall health does not support chemotherapy plus immunotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGToripalimab + Chemotherapy

Toripalimab is the study drug and will be given via IV in all arms except "Rad+/-Chem : Adjuvant radiation or chemoradiotherapy"

DRUGToripalimab

Study drug

RADIATIONChemoradiotherapy or radiation

In the adjuvant phase, either radiation or chemoradiotherapy is used for treatment


Locations(1)

Johns Hopkins Hospital East Baltimore

Baltimore, Maryland, United States

View Full Details on ClinicalTrials.gov

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NCT07209189


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