Study on Pembrolizumab and N-803, Alone or with PD-L1 t-haNK Cells, for Treating Resectable Head and Neck Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT06161545

Provider View

This clinical trial is testing a new combination of drugs, including pembrolizumab and N-803, with or without PD-L1 t-haNK cells, to see if they can help the immune system fight head and neck cancer that can be surgically removed.

Patient Parameters

Program Overview

The study aims to find out if a new drug treatment, using pembrolizumab and N-803, with or without PD-L1 t-haNK cells, can help the immune system fight head and neck squamous cell carcinoma (HNSCC). This type of cancer can form tumors in the head and neck area, and the study is focused on cases not linked to human papillomavirus (HPV). Participants must be adults who have not yet received any treatment and are scheduled for surgery to remove the tumors.

Description

This study is exploring a new treatment for head and neck squamous cell carcinoma (HNSCC) that is not related to HPV. The treatment involves using pembrolizumab and N-803, with or without PD-L1 t-haNK cells, to help the immune system attack cancer cells.

Participants will first undergo screening, which includes a physical exam, blood and urine tests, imaging scans, and a heart function test. A biopsy will also be performed to take a sample from the tumor.

On the first day of treatment, all participants will receive pembrolizumab through an IV and N-803 as an injection under the skin. Some participants will also receive PD-L1 t-haNK cells through an IV on specific days.

Follow-up visits will occur on days 8, 15, 21, 49, and 105, with additional check-ins every 9 weeks for up to 2 years. The study aims to see if this treatment can reduce the amount of cancer in the tumor area that is surgically removed.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years or older with head and neck squamous cell carcinoma (HNSCC) that is not linked to HPV.
  • Cancer must be at an intermediate or high risk and not have been treated before.
  • Must be scheduled for surgery to remove the cancer.
  • Must have good overall health and organ function, as shown by specific blood tests.
  • Must agree to use effective birth control during the study and for 4 months after the last treatment.
  • Must be willing to have biopsies before and after treatment.
  • Must be able to understand and sign a consent form to participate.

Exclusion Criteria

  • History of severe allergic reactions to similar drugs used in the study.
  • Currently taking high doses of immunosuppressive medications.
  • History of autoimmune diseases, except for certain controlled conditions.
  • History of hepatitis B infection.
  • Active cancer within the last 2 years, except for certain types that are considered cured.
  • Recent use of investigational drugs.
  • Pregnant or breastfeeding women.
  • Uncontrolled medical conditions that could increase risks or affect study results.

Locations

FACILITYZIPCITYSTATE
National Institutes of Health Clinical Center20892BethesdaMaryland

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