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 post initiation of anti-PD-1 treatment in
Cohort 1 and prior to tumor resection or radiation in Cohort 2
Title
- Brief Title: Study to Evaluate Immunological Response to PD-1 Inhibition in Squamous Cell Carcinoma of the Head and Neck (SCCHN)
- Official Title: A Pilot Study to Evaluate Immunological Response to PD-1 Inhibition in Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Clinical Trial IDs
- ORG STUDY ID:
40425
- SECONDARY ID:
ENT0061
- NCT ID:
NCT03129061
Conditions
- Squamous Cell Carcinoma of the Head and Neck
Interventions
| Drug | Synonyms | Arms |
|---|
| [18F]F-AraG PET Scan, baseline + post anti-PD-1 therapy. | | Cohort 1 Patients with M/R SCCHN |
| [18F]F-AraG PET Scan, baseline + post anti-PD-1 therapy. | | Cohort 2 Patients with de novo SCCHN |
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
Detailed 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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Cohort 1 Patients with M/R SCCHN | Experimental | 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. | - [18F]F-AraG PET Scan, baseline + post anti-PD-1 therapy.
|
| Cohort 2 Patients with de novo SCCHN | Experimental | 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. | - [18F]F-AraG PET Scan, baseline + post anti-PD-1 therapy.
|
Eligibility 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.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Non-invasive assessment of T cell activation at tumor site from anti-PD1 therapy as measured by signal changes with VisAcT imaging biomarker |
| Time Frame: | Baseline and 6 to 12 weeks after initial anti-PD-1 dose in Cohort 1 and Baseline and 2 to 3 weeks after anti-PD-1 dose in Cohort 2. |
| Safety Issue: | |
| Description: | Assess whether [18F]F-AraG accumulation at the site of inflammation 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). |
Secondary Outcome Measures
| Measure: | Success rate for collection of paired blood and tissue samples pre and post immunotherapy treatment in each Cohort. |
| Time Frame: | 2 to 3 weeks post initial anti-PD-1 dose. |
| Safety Issue: | |
| Description: | Explore the feasibility of deep sequencing the tumor cells and also the paired T cell receptor alpha and beta chains of the expanding T cells from the same patient before and after the administration of a Moab directed against PD-1. |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | CellSight Technologies, Inc. |
Last Updated
January 26, 2021
