OncoMatch/Clinical Trials/NCT07209189
Neoadjuvant Chemotherapy and Programmed Cell Death Protein 1(PD-1) Inhibition for Head and Neck Cancer Treatment De-escalation (NeoScorch HN)
Is NCT07209189 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Toripalimab + Chemotherapy and Toripalimab for head and neck cancer.
Treatment: Toripalimab + Chemotherapy · Toripalimab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: HPV16 positive
HPV16 type only. Patients with non-HPV16 cancers are not eligible. If p16 immunohistohemistry (IHC) positivity is the only result available at enrollment, neoadjuvant therapy may start while HPV nucleic acid testing is pending. Patients found to be HPV non-16 must discontinue study participation.
Allowed: IDH2 mutation
sinonasal undifferentiated carcinoma (e.g., Isocitrate dehydrogenase 2 (IDH2) mutant)
Disease stage
Required: Stage AJCC 7TH EDITION: STAGE III-IV, EXCLUDING N2C OR BULKY N2B/C (N3 EQUIVALENT) AND BULKY T4 (≥30CC), AJCC 8TH EDITION: STAGE I WITH N1, STAGE II, OR STAGE III, EXCLUDING N2 DISEASE, BULKY NODAL DISEASE (N3 EQUIVALENT), OR BULKY T4 (≥30CC) (AJCC 7th and 8th edition)
Excluded: Stage N2C OR BULKY N2B/C (N3 EQUIVALENT), BULKY T4 (≥30CC), N2 DISEASE (AJCC 8TH EDITION), BULKY NODAL DISEASE (N3 EQUIVALENT, AJCC 8TH EDITION)
AJCC 7th edition: Stage III-IV, excluding N2c or bulky N2b/c (N3 equivalent) and bulky T4 (≥30cc). AJCC 8th edition: Stage I with N1, Stage II, or Stage III, excluding N2 disease, bulky nodal disease (N3 equivalent), or bulky T4 (≥30cc).
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: PD-1/PD-L1/PD-L2 inhibitor or T-cell receptor targeting agent
Prior treatment with PD-1, PD-L1, PD-L2 inhibitors, or other agents targeting T-cell receptors (e.g., CTLA-4, OX40, CD137)
Cannot have received: systemic anti-cancer therapy
No prior systemic therapy, radiotherapy, or investigational agents for the current cancer.
Cannot have received: radiotherapy
Exception: A 1-week washout is permitted for palliative, non-stereotactic radiation (≤2 weeks) to non-CNS, non-head and neck disease, provided there are no residual toxicities, no steroid requirement, and no history of radiation pneumonitis.
Radiotherapy within 2 weeks of study start. A 1-week washout is permitted for palliative, non-stereotactic radiation (≤2 weeks) to non-CNS, non-head and neck disease, provided there are no residual toxicities, no steroid requirement, and no history of radiation pneumonitis.
Cannot have received: investigational agent
Exception: unless in follow-up phase only
Participation in another investigational drug or device study within 4 weeks before first study dose, unless in follow-up phase only.
Lab requirements
Blood counts
platelets ≥100,000/µL; ANC ≥1,500/µL; hemoglobin ≥9 g/dL (without recent transfusion/EPO)
Kidney function
creatinine clearance ≥60 mL/min (Cockcroft-Gault or measured GFR)
Liver function
AST/ALT <2.5 × ULN; total bilirubin ≤1.5 × ULN or direct bilirubin ≤ULN if total >1.5 × ULN; albumin ≥2.5 mg/dL
Platelets ≥100,000/µL. Absolute Neutrophil Count (ANC) ≥1,500/µL. Hemoglobin ≥9 g/dL (without recent transfusion/EPO). AST/ALT <2.5 × ULN. Albumin ≥2.5 mg/dL. Total bilirubin ≤1.5 × ULN or direct bilirubin ≤ULN if total >1.5 × ULN. Creatinine clearance ≥60 mL/min (Cockcroft-Gault or measured GFR).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Johns Hopkins Hospital East Baltimore · Baltimore, Maryland
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