OncoMatch/Clinical Trials/NCT04754321
Combining Immunotherapy Salvage Surgery & IORT Tx Persistent/Recurrent Head & Neck Cancer
Is NCT04754321 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Pembrolizumab for head and neck carcinoma of unknown primary.
Treatment: Pembrolizumab — This phase I trial is to find out the possible side effects of pembrolizumab and radiation therapy before and during surgery in treating patients with head and neck squamous cell cancer that remains despite treatment (persistent) or has come back (recurrent). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays or protons to kill tumor cells and shrink tumors. Giving pembrolizumab and radiation therapy before and during surgery may kill more tumor cells.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: surgery and/or chemotherapy and/or radiotherapy
Patients who have undergone therapy for their cancer, such as surgery and/or chemotherapy and/or radiotherapy and recurred
Cannot have received: immune checkpoint blockade agent
Prior use of immune checkpoint blockade agent
Lab requirements
Blood counts
WBC ≥ 2000/uL; Neutrophils ≥ 1500/uL; Platelets ≥ 100 x10^3/uL; Hemoglobin > 9.0 g/dL
Kidney function
Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance (CrCl) ≥ 40 mL/min
Liver function
AST and ALT ≤ 3 x institutional ULN; Total Bilirubin ≤ 1.5 x institutional ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
Adequate hematologic, renal, and hepatic function; WBC ≥ 2000/uL; Neutrophils ≥ 1500/uL; Platelets ≥ 100 x10^3/uL; Hemoglobin > 9.0 g/dL; Serum creatinine ≤ 1.5 x ULN or CrCl ≥ 40 mL/min; AST and ALT ≤ 3 x institutional ULN; Total Bilirubin ≤ 1.5 x institutional ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Ohio State University Comprehensive Cancer Center · Columbus, Ohio
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