Status:
RECRUITING
Pembrolizumab + N-803 Alone or in Combination With PD-L1 t-haNK Cells for Resectable Head and Neck Squamous Cell Carcinoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Stage II Squamous Cell Carcinoma of the Head and Neck
Stage III Squamous Cell Carcinoma of the Head and Neck
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
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 year...
Detailed Description
Background: * Even in the potentially curative setting, human papillomavirus (HPV)-unrelated head and neck squamous cell carcinomas (HNSCC) are associated with dismal outcomes (compared to HPV-relate...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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 CRITERIA:
- 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.
Exclusion
Key Trial Info
Start Date :
September 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06161545
Start Date
September 24 2025
End Date
December 1 2028
Last Update
October 17 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892