OncoMatch/Clinical Trials/NCT06161545
Pembrolizumab + N-803 Alone or in Combination With PD-L1 t-haNK Cells for Resectable Head and Neck Squamous Cell Carcinoma
Is NCT06161545 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including PD-L1 t-haNK cells and pembrolizumab for stage ii squamous cell carcinoma of the head and neck.
Treatment: PD-L1 t-haNK cells · pembrolizumab · N-803 — Background: Squamous cell carcinoma is a type of cancer that can cause tumors on the head and neck (HNSCC). Even with treatment, less than 50% of people with certain types of HNSCC survive for 5 years. Objective: To test a new drug treatment (N-803 and pembrolizumab, with or without PD-L1 t-haNK cells) in people with HNSCC. These drugs may help the immune system to fight cancer. Eligibility: People aged 18 years and older who have HNSCC that is not linked to human papillomavirus infection. They must not yet have received any treatment and be scheduled for surgery to remove the tumors. Design: Participants will be screened. They will have a physical exam with blood and urine tests. They will have imaging scans and a test of their heart function. They will have a biopsy: A sample of tissue will be removed from the tumor. Pembrolizumab is given through a tube attached to a needle inserted into a vein in the arm (intravenous infusion). N-803 is injected under the skin of the abdomen. All participants will receive these 2 treatments on day 1. They will have follow-up visits on days 8 and 15. Some participants will also receive PD-L1 t-haNK cells by intravenous infusion. These are cells that attack cancer cells. These participants will receive this treatment on days 1, 5, 8, 12, and 15. All participants will have a clinic visit on day 21. They will have a second biopsy. Follow-up visits will occur on days 49 and 105. Visits will continue by phone or email every 9 weeks for 2 years....
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: CDKN2A wild-type
p16-negative (if oropharyngeal primary tumor)...p16 status will be determined by a history of p16 immunohistochemistry (IHC) staining conducted per standard of care
Disease stage
Required: Stage II, III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: investigational drug
Lab requirements
Blood counts
ANC >= 1.0 x 10^9/L; Hemoglobin >= 10.0 g/dL; Platelet count >= 100 x 10^9/L; PT and PTT <= 1 x ULN (PTT exception: lupus anticoagulant)
Kidney function
Creatinine <= 1.5 x ULN
Liver function
ALT and AST <= 3.0 x ULN; total bilirubin <= 1 x ULN (Gilbert's syndrome < 3.0 mg/dL)
Participants must have adequate organ and marrow function as defined below: * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 3.0 x upper limit of normal (ULN) * Total bilirubin <= 1 x ULN. Note: Participants with Gilbert's syndrome can have total bilirubin < 3.0 mg/dL * Absolute neutrophil count (ANC) >= 1.0 x 10^9/L * Hemoglobin (Hgb) >= 10.0 g/dL * Platelet count >= 100 x 10^9/L * Prothrombin time (PT) and partial thromboplastin time (PTT) <= 1 x ULN. Note: Participants with prolonged PTT determined to be due to lupus anticoagulant are eligible * Creatinine <= 1.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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