Pembrolizumab and N-803 for Head and Neck Cancer
This study is testing new drug treatments for head and neck squamous cell carcinoma (HNSCC), a type of cancer that can form tumors in the head and neck. Researchers are looking at pembrolizumab and N-803, either alone or combined with PD-L1 t-haNK cells. These treatments aim to help your immune system fight cancer. You may be able to join if you are 18 or older, have untreated Stage II, III, or IV HNSCC that is not linked to human papillomavirus (HPV), and are scheduled for surgery. The main goal is to see how much of the tumor is removed or reduced by these treatments before surgery. The study plans to enroll 40 participants, but its current recruitment status is unclear.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 40 participants.
- What's involved
- You will have a physical exam, blood and urine tests, imaging scans, and a heart function test. You will receive intravenous (IV) infusions of PD-L1 t-haNK cells and pembrolizumab, and subcutaneous injections of N-803.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome is measured from enrollment to 5 days after the last infusion of PD-L1 t-haNK cells or at least 20 days after pembrolizumab/N-803 administration.
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NCT06161545
Pembrolizumab + N-803 Alone or in Combination With PD-L1 t-haNK Cells for Resectable Head and Neck Squamous Cell Carcinoma
Recruiting
PHASE2Ages 18+InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~40 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:PD-L1 t-haNK cellspembrolizumabN-803
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
pTR rate (viable tumor in 50% or less of the surgically resected primary tumor bed)
Measured over From enrollment to 5 days after the last infusion of PD-L1 t-hank cells or at least 20 days after pembrolizumab/N-803 administration.
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Charalampos Floudas, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Histologically or cytologically confirmed previously untreated intermediate/high risk, p16-negative (if oropharyngeal primary tumor), squamous cell carcinoma of the head and neck (T1-T4, N0-N3, M0 stage II, III or IV). Note: p16 status will be determined by a history of p16 immunohistochemistry (IHC) staining conducted per standard of care.
Age \>= 18 years.
ECOG performance status \<= 1.
Planned for cancer removal surgery per standard of care.
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
Participants with a history of human immunodeficiency virus (HIV) infection must:
be on effective anti-retroviral therapy; and
have the viral load \< 400 copies/mL; and
have the CD4 count \> 150 cells/microL
Participants with a history of Hepatitis C virus (HCV) infection must
received curative treatment; and
have an undetectable viral load.
Individuals of child-bearing potential (IOCBP) and those who can father children must agree to use an effective method of contraception (barrier, hormonal, intrauterine device (IUD), surgical sterilization) for the duration of the study treatment and up to 4 months after the last dose of the study drug (s).
Nursing participants must be willing to discontinue nursing from study treatment initiation through 4 months after the last dose of the study drug(s).
Participants must have a primary tumor site that is amenable to biopsy and be willing to undergo pre-and post-treatment biopsies.
The ability of a participant to understand and the willingness to sign a written informed consent document.
Exclusion
History of allergic reactions attributed to compounds of similar chemical or biological composition to drugs used in the study.
Active immunosuppressive treatment equivalent of \> 10mg of prednisone daily. Note: Short-course systemic corticosteroids (e.g., prevention/treatment for transfusion reaction) or use for a non-cancer indication (e.g., adrenal replacement) is acceptable.
History of autoimmune disease with the exception of controlled thyroid disease, psoriasis not requiring medications, vitiligo, and alopecia.
Participants with a history of hepatitis B (HBV).
Prior malignancy active within the previous 2 years except for locally curable cancer that is currently considered cured and does not require an additional standard of care treatment, such as cutaneous basal or squamous cell carcinoma, superficial bladder cancer, or cervical carcinoma in situ, or an incidental histological finding of prostate cancer.
Prior therapy with the investigational drug within 2 weeks prior to the treatment initiation.
Pregnancy (confirmed with Beta-human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test performed in individuals of childbearing potential at screening).
Uncontrolled intercurrent illness or medical condition(s) evaluated by medical history and physical exam or situations that are not stable (e.g., recent hospitalization, Emergency Room visit or undergoing medication changes) that the investigator assesses would unacceptably increase of participation in the trial for the participant or impair the ability to evaluate the endpoints of the study.
What this trial measures
- pTR rate (viable tumor in 50% or less of the surgically resected primary tumor bed)From enrollment to 5 days after the last infusion of PD-L1 t-hank cells or at least 20 days after pembrolizumab/N-803 administration.
Digital pathology software assessment of H and E slides from the surgical specimen. The fraction of participants on each arm who experience a pathologic tumor response (pTR) will be reported along with a 95% confidence interval.