OncoMatch/Clinical Trials/NCT07869823
Cemiplimab and Quad Shot Radiation for Cutaneous Squamous Cell Carcinoma in the Head and Neck
Official title: Feasibility Study of Cemiplimab and Quad Shot Radiation in Elderly, Frail, or High Comorbidity Patients With Locally Advanced Cutaneous Squamous Cell Carcinomas of the Skin Arising in the Head and Neck Region
Is NCT07869823 recruiting? Yes, currently enrolling (Oct 2026). This Early Phase 1 trial studies Cemiplimab for cutaneous squamous cell carcinoma.
Treatment: Cemiplimab — The goal of this clinical trial is to learn if the combination of the drug cemiplimab along with a short course of radiation therapy called Quad Shot can be successfully given in several rounds to elderly or frail patients with head and neck skin cancers. The main question it aims to answer is: \- Can care providers successfully deliver at least 6 rounds of cemiplimab and 3 rounds of Quad Shot radiation to patients? Patients will: * Be given cemiplimab every 3 weeks for a total of up to 8 doses * Be given Quad Shot radiation (four treatments over two days) every 3 weeks for a total of up to 4 rounds
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Performance status
ECOG 3–4(Completely disabled)
Prior therapy
Cannot have received: systemic therapy
No prior systemic therapy including chemotherapy, targeted therapy or immunotherapy
Cannot have received: systemic therapy for locally advanced cutaneous carcinoma of the head and neck
Prior systemic therapy for locally advanced cutaneous carcinoma of the head and neck (LACCHN)
Cannot have received: checkpoint inhibitor
Prior treatment with checkpoint inhibitor therapy
Cannot have received: radiation therapy for recurrent disease
recurrent disease has not been previously treated with radiation therapy
Lab requirements
Blood counts
ANC ≥ 1,000/ul; Platelets ≥ 75,000/ul; Hemoglobin ≥ 7 g/dL (without transfusion in prior 4 weeks)
Kidney function
Calculated serum creatinine clearance > 20 mL/min by Cockcroft-Gault (or < 20 mL/min if on stable dialysis)
Liver function
Total bilirubin ≤ 1.5x UNL (except Gilbert syndrome < 3 mg/dl); AST/ALT ≤ 3.0x UNL
Adequate organ function as defined by: ANC ≥ 1,000/ul; Platelets ≥ 75,000/ul; Hemoglobin ≥ 7 g/dL (without requirement for transfusion in prior 4 weeks); Calculated serum creatinine clearance > 20 mL/min by the Cockcroft-Gault formula (clearance < 20mL/min will be allowed if patient is on a stable dialysis regimen); Total bilirubin ≤ 1.5 X upper normal limit (UNL) (except subjects with Gilbert syndrome, who can have total bilirubin < 3 mg/dl); Aspartate aminotransferase (AST) ≤ 3.0 X UNL; Alanine aminotransferase (ALT) ≤ 3.0 X UNL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Washington University Medical Center · St Louis, Missouri
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07869823 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic therapy, systemic therapy for locally advanced cutaneous carcinoma of the head and neck, checkpoint inhibitor disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify