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

Conditions

• Stage II Squamous Cell Carcinoma of the Head and Neck
• Stage III Squamous Cell Carcinoma of the Head and Neck
• Stage IV Squamous Cell Carcinoma of the Head and Neck

Eligibility Criteria

Sex

ALL

Age

18 Years - 120 Years

Healthy Volunteers

Not accepted

Interventions

• PD-L1 t-haNK cells — BIOLOGICAL
  Irradiated PD-L1 t-haNK cells at a dose of 2 x 10\^9 administered via IV infusion over 30 minutes on Days 1, 5, 8, 12, and 15
• pembrolizumab — DRUG
  400 mg administered as a 30 minute IV infusion on Day 1
• N-803 — DRUG
  15 ug/kg via subcutaneous injection on Day 1

Study Details

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....

Key Dates

Start date

Sep 24, 2025

Status verified

Oct 2025

Primary completion

Dec 1, 2026

Completion

Dec 1, 2028

Study Design

Enrollment

40 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1
  N-803 + pembrolizumab
• Experimental: Arm 2
  N-803 + pembrolizumab + PD-L1 t-haNK cells

Primary Outcome Measure

pTR rate (viable tumor in 50% or less of the surgically resected primary tumor bed) [ Time Frame: 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. ]

Central Contacts

• NCI Medical Oncology Referral Office
  (240) 760-6050
  [email protected]

Locations (1)

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