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

CellSight Technologies

Status and phase: Completed; Phase 1

Conditions: Squamous Cell Carcinoma of the Head and Neck

Treatments: Drug: [18F]F-AraG PET Scan, baseline + post anti-PD-1 therapy.

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03129061

40425

ENT0061 (Other Identifier)

Details and patient eligibility

About

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

Full description

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 6-12 weeks post initiation of anti-PD-1 treatment in Cohort1 and within 2-3 weeks of administration of one dose of anti-PD-1 in Cohort 2.

This study will help us assess if [18F]F-AraG can be used for noninvasive imaging and assessment of T cell activation and expansion in the tumor microenvironment. Specifically, we will be assessing if there is a correlation between an increase in the imaging signal and an increase in T cell activation (measured directly from the T cells obtained from biopsy specimens).

Patients and care providers will not be blinded to any part of this study. Patients will be evaluated one day and one week via telephone visit after each radiopharmaceutical injection for safety follow-up. All adverse events will be recorded. Due to the noninvasive and non-therapeutic nature of the study, potential risks of the study are anticipated to be low.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Cohort 1 Patients with M/R SCCHN

Experimental group

Description:

Patients with unresectable and metastatic SCCHN cancer who will receive anti-PD-1 treatment under SOC. SOC treatments currently include nivolumab and pembrolizumab ("anti-PD-1 treatment"). The protocol may be amended to include other agents should they become SOC. Patients will receive a baseline \[18F\]F-AraG PET/CT scan and another \[18F\]F-AraG PET/CT scan 6 to 12 weeks after anti-PD-1 dose.

Treatment:

Drug: [18F]F-AraG PET Scan, baseline + post anti-PD-1 therapy.

Drug: [18F]F-AraG PET Scan, baseline + post anti-PD-1 therapy.

Cohort 2 Patients with de novo SCCHN

Experimental group

Description:

Patients with de novo SCCHN prior to initiation of anti-cancer treatment (e.g., radiation, chemoradiation, or surgery). Patients will receive ONE DOSE of the anti-PD-1 treatment, after the baseline \[18F\]F-AraG PET/CT scan, baseline blood and tumor tissue collection. Patients will receive a second \[18F\]F-AraG PET/CT scan 2 - 3 weeks after the one dose of anti-PD-1 treatment.

Treatment:

Drug: [18F]F-AraG PET Scan, baseline + post anti-PD-1 therapy.

Drug: [18F]F-AraG PET Scan, baseline + post anti-PD-1 therapy.