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

Not Applicable

Not yet recruiting

• 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; Drug: Toripalimab; Radiation: Chemoradiotherapy or radiation

• Registration Number: NCT07209189
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-09-30
• Study First Submitted QC: 2025-09-30
• Status Verified: 2025-10
• Study First Posted: 2025-10-06
• Last Update Submitted: 2025-10-06
• Last Update Posted: 2025-10-09
• Study Start: 2025-10-25
• Primary Completion: 2030-10-01
• Study Completion: 2030-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neo + Surg : Neoadjuvant Treatment and surgery	Toripalimab + Chemotherapy	Neoadjuvant Chemotherapy with * Toripalimab + Cisplatin + Docetaxel OR * Toripalimab + Carboplatin + Docetaxel
Adjuvant (ADJ) treatment	Toripalimab	Treated with Toripalimab after adjuvant treatment
Rad+/-Chem : Adjuvant radiation or chemoradiotherapy	Chemoradiotherapy or radiation	Radiation or Chemotherapy will be given after the surgery

Primary Outcome Measures

Name	Time	Method
Major Pathological Response (MPR)	Up to 5 years	The objective is to achieve high-quality or "deep" responses to treatment (measurable pathologic response, MPR) that are sufficient to enable surgical de-escalation (less extensive surgery) or response-adaptive, function-preserving surgery (tailoring the surgical approach to preserve organ structure and function while maintaining oncologic safety).