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

• Status: Recruiting
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CellSight Technologies, Inc.
• Collaborator: Stanford University

Criteria

Inclusion Criteria:

• Unresectable or metastatic SCCHN.

• Localized SCCHN.

• >18 years old.

• Willing and able to sign consent form.

• Have standard of care biopsy or resection planned or tumors amenable to serial biopsies.

• For patients with reproductive potential must undergo counseling to understand unknown risks to resultant progeny.

Exclusion Criteria:

• Diagnosis of immunodeficiency or active autoimmune condition.

• Active tuberculosis

• Prior exposure to PD-1 or PD-LI treatment

• Prior systemic chemotherapy within 2 weeks of planed anti-PD1 treatment.

• Received a live vaccine within 30 days of planned PD-1 start date.

• Pregnant or breastfeeding.