OncoMatch/Clinical Trials/NCT06855212
Phase II Study of Neoadjuvant Cetuximab and Cemiplimab in Patients Undergoing Surgery for HNSCC
Is NCT06855212 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Cemiplimab and Cetuximab for head and neck squamous cell carcinoma.
Treatment: Cemiplimab · Cetuximab — The purpose of the study is to determine if cemiplimab in combination with cetuximab given before their surgery are beneficial and safe in participants with head and neck squamous cell carcinoma (HNSCC).
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) expression (CPS determination required) (CPS determination required; no threshold specified)
Must have sufficient archived tumor tissue available for PD-L1 CPS determination. If not, patient must agree to a fresh tumor biopsy before starting the treatments.
Required: CDKN2A p16 expression (required for oropharynx primary) (testing required; no threshold specified)
If the primary site is oropharynx, p16/HPV status must be determined.
Required: HPV HPV status (required for oropharynx primary) (testing required; no threshold specified)
If the primary site is oropharynx, p16/HPV status must be determined. HPV status determined by cell free HPV DNA testing is also acceptable.
Disease stage
Required: Stage T1-2 N1-3, T3-4 N0-3
Must be newly diagnosed HNSCC with T1-2 N1-3 or T3-4 N0-3 undergoing surgery as a standard of care. If the tumor invades lateral pterygoid muscle, pterygoid plates, lateral nasopharynx, skull base or encases carotid artery, and/or prevertebral fascia involvement, it will be considered as unresectable and excluded.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Lab requirements
Blood counts
Must meet the laboratory criteria outlined in the protocol.
Kidney function
Must meet the laboratory criteria outlined in the protocol.
Liver function
Must meet the laboratory criteria outlined in the protocol.
Cardiac function
Patients with a history of a left ventricular ejection fraction (LVEF) of < 45% or who are New York Heart Association (NYHA) Class 2 or higher [excluded]. Patients with cardiovascular disease defined as: Uncontrolled hypertension > 160/90 mmHg at Screening confirmed by repeat (medication permitted). History of torsades de pointes, significant ECG abnormalities, including ventricular rhythm disturbances, unstable cardiac arrhythmia requiring medication, pathologic symptomatic bradycardia, left bundle branch block, second degree AV block type II, third degree AV block, Grade ≥ 2 bradycardia, uncorrected hypokalemia not amenable to correction, congenital long QT syndrome, prolonged QT interval due to medications, corrected QT (QTc) > 450 msec (for men) or > 470 msec (for women). Symptomatic heart failure (per NYHA guidelines), unstable angina, myocardial infarction, severe cardiovascular disease (ejection fraction < 20%, transient ischemic attack, or cerebrovascular accident within 12 months of Day 1).
Must meet the laboratory criteria outlined in the protocol. Patients with a history of a left ventricular ejection fraction (LVEF) of < 45% or who are New York Heart Association (NYHA) Class 2 or higher [excluded]. Patients with cardiovascular disease defined as: Uncontrolled hypertension > 160/90 mmHg at Screening confirmed by repeat (medication permitted). History of torsades de pointes, significant ECG abnormalities, including ventricular rhythm disturbances, unstable cardiac arrhythmia requiring medication, pathologic symptomatic bradycardia, left bundle branch block, second degree AV block type II, third degree AV block, Grade ≥ 2 bradycardia, uncorrected hypokalemia not amenable to correction, congenital long QT syndrome, prolonged QT interval due to medications, corrected QT (QTc) > 450 msec (for men) or > 470 msec (for women). Symptomatic heart failure (per NYHA guidelines), unstable angina, myocardial infarction, severe cardiovascular disease (ejection fraction < 20%, transient ischemic attack, or cerebrovascular accident within 12 months of Day 1).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Moffitt Cancer Center · Tampa, Florida
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