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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)

NCT07209189 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-04-23

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Coherus Oncology, Inc.

    collaborator INDUSTRY

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Nyall R London, MD, Ph.D · Otolaryngology - Broadway

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-18
Primary Completion
2030-10-01
Completion
2030-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07209189 on ClinicalTrials.gov