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.
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.