RecruitingPhase IIEN originalHead and neck cancer

Pembrolizumab + N-803 Alone or in Combination With PD-L1 t-haNK Cells for Resectable Head and Neck Squamous Cell Carcinoma

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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....

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Wiek co najmniej 18 lat
  • Potwierdzony rak płaskonabłonkowy głowy i szyi stadium II, III lub IV, który nie jest związany z wirusem HPV
  • Brak poprzedniego leczenia onkologicznego
  • Zaplanowana operacja chirurgiczna w celu usunięcia guza
  • Prawidłowe funkcjonowanie wątroby, nerek i krwiotwórczych (wykazane w badaniach krwi)
  • Osoby zarażone HIV muszą być na skutecznym leczeniu z niewykrywalnym wirusem
  • Osoby zarażone wirusem zapalenia wątroby C muszą mieć niewykrywalny wirus
  • Osoby w wieku rozrodczym muszą stosować skuteczne antykoncepcję przez badanie i 4 miesiące po ostatniej dawce leku

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Maximum age
120 Years
Last updated (source)
August 24, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (1)

National Institutes of Health Clinical Center

Bethesda, United States

Trial contact

NCI Medical Oncology Referral Office

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/25/2026.

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