Actively Recruiting
Pembrolizumab + N-803 Alone or in Combination With PD-L1 t-haNK Cells for Resectable Head and Neck Squamous Cell Carcinoma
Led by National Cancer Institute (NCI) · Updated on 2026-04-08
40
Participants Needed
1
Research Sites
166 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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....
CONDITIONS
Official Title
Pembrolizumab + N-803 Alone or in Combination With PD-L1 t-haNK Cells for Resectable Head and Neck Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed previously untreated intermediate/high risk, p16-negative (if oropharyngeal tumor) squamous cell carcinoma of the head and neck (T1-T4, N0-N3, M0 stage II, III, or IV)
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Planned for cancer removal surgery
- Adequate organ and marrow function including ALT and AST less than or equal to 3.0 x upper limit of normal (ULN)
- Total bilirubin less than or equal to 1 x ULN (participants with Gilbert's syndrome can have total bilirubin less than 3.0 mg/dL)
- Absolute neutrophil count (ANC) greater than or equal to 1.0 x 10^9/L
- Hemoglobin greater than or equal to 10.0 g/dL
- Platelet count greater than or equal to 100 x 10^9/L
- Prothrombin time (PT) and partial thromboplastin time (PTT) less than or equal to 1 x ULN (participants with prolonged PTT due to lupus anticoagulant are eligible)
- Creatinine less than or equal to 1.5 x ULN
- If HIV positive: on effective anti-retroviral therapy with viral load less than 400 copies/mL and CD4 count greater than 150 cells/microL
- If history of Hepatitis C virus infection: received curative treatment and have undetectable viral load
- Individuals of child-bearing potential and those who can father children must agree to use effective contraception during treatment and for 4 months after last dose
- Nursing participants must agree to stop nursing from treatment start through 4 months after last dose
- Primary tumor site amenable to biopsy and willingness to undergo pre- and post-treatment biopsies
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- History of allergic reactions to drugs similar to those used in the study
- Use of active immunosuppressive treatment equivalent to more than 10 mg of prednisone daily (short courses or non-cancer uses allowed)
- History of autoimmune disease except controlled thyroid disease, psoriasis not requiring medication, vitiligo, or alopecia
- History of hepatitis B infection
- Prior malignancy active within the past 2 years except certain locally curable cancers considered cured
- Prior therapy with the investigational drug within 2 weeks before treatment start
- Pregnancy confirmed by blood or urine test in individuals of childbearing potential
- Uncontrolled illness or unstable medical conditions that increase risk or impair study evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
N
NCI Medical Oncology Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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