Study to Evaluate Immunological Response to PD-1 Inhibiti... | NCT03129061

ID	Type	Description	Link
ENT0061	Other Identifier	Stanford University

Status Module

Name	Class
Stanford University	OTHER

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Drug: [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.	Drug: [18F]F-AraG PET Scan, baseline + post anti-PD-1 therapy.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
[18F]F-AraG PET Scan, baseline + post anti-PD-1 therapy.	Drug	Baseline: Blood sampling, tumor biopsy, [18F]F-AraG PET/CT scan within two weeks prior to standard of care anti-PD-1 therapeutic dose. Anti PD-1 per standard of care Blood sampling and tumor biopsy within 2-3 weeks after first anti-PD-1 SOC dose. [18F]F-AraG PET/CT scan 6 - 12 weeks post first anti-PD-1 dose.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Non-invasive assessment of T cell activation at tumor site from anti-PD1 therapy as measured by signal changes with VisAcT imaging biomarker	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).	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.

Secondary Outcomes

Measure	Description	Time Frame
Success rate for collection of paired blood and tissue samples pre and post immunotherapy treatment in each Cohort.	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.	2 to 3 weeks post initial anti-PD-1 dose.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
A. Dimitrios Colevas, MD	Stanford University	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Stanford Hospital and Clinics		Stanford	California	94305	United States

IPD Sharing Statement Module

ID	Term
D002294	Carcinoma, Squamous Cell
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site