Study to Evaluate Immunological Response to PD-1 Inhibition in Squamous Cell Carcinoma of the Head and Neck (SCCHN)

This is a single-center cross-sectional imaging and correlative biomarker study in

patients with Squamous Cell Carcinoma of the Head and Neck (SCCHN). Cohort 1 will be

patients with unresectable or metastatic SCCHN cancer receiving standard of care (SOC)

anti-PD-1 treatment and cohort 2 will be neoadjuvant study participants who will receive

one dose of anti-PD-1 treatment prior to tumor resection or radiation. Blood sampling and

tissue biopsies will be collected from both cohorts and both cohorts will undergo two

whole body PET(Positron Emission Tomography)/CT(Computed Tomography) imaging with

[18F]F-AraG. First scan prior to initiating anti-PD-1 treatment and second scan 6-12

weeks post initiation of anti-PD-1 treatment in Cohort1 and within 2-3 weeks of

administration of one dose of anti-PD-1 in Cohort 2.

This study will help us assess if [18F]F-AraG can be used for noninvasive imaging and

assessment of T cell activation and expansion in the tumor microenvironment.

Specifically, we will be assessing if there is a correlation between an increase in the

imaging signal and an increase in T cell activation (measured directly from the T cells

obtained from biopsy specimens).

Patients and care providers will not be blinded to any part of this study. Patients will

be evaluated one day and one week via telephone visit after each radiopharmaceutical

injection for safety follow-up. All adverse events will be recorded. Due to the

noninvasive and non-therapeutic nature of the study, potential risks of the study are

anticipated to be low.