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Study to Evaluate Immunological Response to PD-1 Inhibition in Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Not Recruiting
Trial ID: NCT03129061
Purpose
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
Official Title
A Pilot Study to Evaluate Immunological Response to PD-1 Inhibition in Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Stanford Investigator(s)
A. Dimitrios Colevas, MD
Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)
Guido A. Davidzon
Clinical Associate Professor, Radiology - Rad/Nuclear Medicine
Quynh-Thu Le, MD
Katharine Dexter McCormick and Stanley McCormick Memorial Professor and Professor, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS)
John B. Sunwoo, MD
Edward C. and Amy H. Sewall Professor in the School of Medicine and Professor, by courtesy, of Dermatology
Eligibility
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.
Intervention(s):
drug: [18F]F-AraG PET Scan, baseline + post anti-PD-1 therapy.
drug: [18F]F-AraG PET Scan, baseline + post anti-PD-1 therapy.
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Savanna Biedermann
650-721-4079