Study to Evaluate Immunological Response to PD-1 Inhibition in Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Trial ID or NCT#
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
A Pilot Study to Evaluate Immunological Response to PD-1 Inhibition in Squamous Cell Carcinoma of the Head and Neck (SCCHN)
- - 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.
- - 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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