Clinical Trial · NCT03129061

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

Overview

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 post initiation of anti-PD-1 treatment in Cohort 1 and prior to tumor resection or radiation in Cohort 2

Sponsor

CellSight Technologies

Phase

Phase 1

Contacts

A. Dimitrios Colevas, MD (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT03129061

Drug / Compound

F-AraG

Isotope(s):

Target(s):

Activated T-Cells

Ligand Class: Small Molecules

Eligibility

Inclusion

Willing and able to sign consent form.
Localized SCCHN.
Have standard of care biopsy or resection planned or tumors amenable to serial biopsies.
Unresectable or metastatic SCCHN.
For patients with reproductive potential must undergo counseling to understand unknown risks to resultant progeny.

Exclusion

Prior exposure to PD-1 or PD-LI treatment
Diagnosis of immunodeficiency or active autoimmune condition.
Prior systemic chemotherapy within 2 weeks of planed anti-PD1 treatment.