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NT-I7 for the Treatment of Recurrent Squamous Cell Carcinoma of Head and Neck Undergoing Surgery

Recurrent Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:
A Window of Opportunity Trial of NT-I7 in Patients With Locally Recurrent Squamous Cell Carcinoma of Head and Neck (SCCHN) Undergoing Salvage Surgery

Clinical Trial Summary

This phase I trial evaluates the side effects of NT-I7 in treating patients with squamous cell carcinoma of head and neck that has come back (recurrent) who are undergoing surgery. NT-I7 is an immunotherapy drug that works by helping the immune system fight tumor cells. The body produces T-cells which play an important role in body's immune response and its ability to recognize tumor cells. This immunotherapy drug may boost body's T-cells to help fight cancer and enhance body's response to cancer.

Clinical Trial Description

PRIMARY OBJECTIVE: I. To evaluate safety and feasibility of a single intramuscular injection of efineptakin alfa (NT-I7) in patients with locally recurrent squamous cell carcinoma of head and neck (SCCHN). SECONDARY OBJECTIVES: I. To describe changes in absolute lymphocyte count (ALC) in peripheral blood after a single dose of NT-I7. II. To describe changes in tumor infiltrating lymphocytes (TIL) in tumor microenvironment of surgical specimen after a single dose of NT-I7. III. To evaluate changes in immune subsets in peripheral blood after a single dose of NT-I7 and after surgery. EXPLORATORY OBJECTIVE: I. To make assessment of exploratory biomarkers for pharmacodynamic activity of NT-I7 in peripheral blood, and/or tumor tissue. OUTLINE: Patients receive one dose of efineptakin alfa intramuscularly (IM). After completion of study treatment, patients are followed up for 35 days after dose or 21 days after surgery. ;

Study Design

Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Squamous Cell
  • Recurrence
  • Recurrent Head and Neck Squamous Cell Carcinoma
  • Recurrent Hypopharyngeal Squamous Cell Carcinoma
  • Recurrent Laryngeal Squamous Cell Carcinoma
  • Recurrent Oral Cavity Squamous Cell Carcinoma
  • Recurrent Oropharyngeal Squamous Cell Carcinoma
  • Resectable Oropharyngeal Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of Head and Neck
Clinical Trial Details
NCT number NCT04588038
Study type Interventional
Source University of California, San Francisco
Contact Angelica Valadez
Phone (415) 502-1879
Email Angelica.Valadez@ucsf.edu
Status Recruiting
Phase Phase 1
Start date March 12, 2021
Completion date March 31, 2024
View Details
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