Spots Global Cancer Trial Database for NT-I7 for the Treatment of Recurrent Squamous Cell Carcinoma of Head and Neck Undergoing Surgery

Study Description

Brief 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.

Detailed 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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