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

Trial ID or NCT#

NCT03129061

Status

not recruiting iconNOT RECRUITING

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)

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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.
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Investigator(s)

A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD
Medical oncologist, Head and neck specialist, Cutaneous oncology specialist
Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)
Guido A. Davidzon
Guido A. Davidzon
Radiologist
Clinical Associate Professor, Radiology - Rad/Nuclear Medicine
Quynh-Thu Le, MD
Quynh-Thu Le, MD
Radiation oncologist
Katharine Dexter McCormick and Stanley McCormick Memorial Professor and Professor, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS)
John B. Sunwoo, MD
John B. Sunwoo, MD
Head and neck surgeon
Edward C. and Amy H. Sewall Professor in the School of Medicine and Professor, by courtesy, of Dermatology

Contact us to find out if this trial is right for you.

Contact

Savanna Biedermann
650-721-4079

View on ClinicalTrials.gov