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NCT06161545 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab + N-803 Alone or in Combination With PD-L1 t-haNK Cells for Resectable Head and Neck Squamous Cell Carcinoma
A Phase 2 study of Stage II Squamous Cell Carcinoma of the Head and Neck and Stage III Squamous Cell Carcinoma of the Head and Neck, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06161545: Recruiting Phase 2 study of Stage II Squamous Cell Carcinoma of the Head and Neck and Stage III Squamous Cell Carcinoma of the Head and Neck, sponsored by National Cancer Institute (NCI).
NCT06161545 is a Phase 2 study of Stage II Squamous Cell Carcinoma of the Head and Neck and Stage III Squamous Cell Carcinoma of the Head and Neck that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06161545, a Phase 2 study of Stage II Squamous Cell Carcinoma of the Head and Neck and Stage III Squamous Cell Carcinoma of the Head and Neck, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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 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....
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG pembrolizumab
- DRUG N-803
- BIOLOGICAL PD-L1 t-haNK cells
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-09-24 |
| Est. Completion | 2028-12-01 |
| Phase | Phase 2 |
What NCT06161545 shows while recruiting
NCT06161545 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 3 conditions, with Stage II Squamous Cell Carcinoma of the Head and Neck appearing as the primary indexed condition, and to 3 interventions - of which pembrolizumab is the first listed.
NCT06161545 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06161545 about?
NCT06161545 is a clinical study titled "Pembrolizumab + N-803 Alone or in Combination With PD-L1 t-haNK Cells for Resectable Head and Neck Squamous Cell Carcinoma". 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 ...
What is the current status of trial NCT06161545?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2025-09-24. Estimated completion is 2028-12-01.
What conditions does trial NCT06161545 study?
This clinical trial studies the following 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.
What interventions are being tested in trial NCT06161545?
The interventions under investigation include: pembrolizumab (DRUG), N-803 (DRUG), PD-L1 t-haNK cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT06161545?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06161545 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06161545's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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