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

NCT03129061 | Completed Phase 1 FDA Drug

• 2 other identifiers: 40425ENT0061
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Squamous Cell Carcinoma of the Head and Neck

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Success rate for collection of paired blood and tissue samples pre and post immunotherapy treatment in each Cohort.

  2 to 3 weeks post initial anti-PD-1 dose.

Study Arms (2)

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

[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.

Cohort 1 Patients with M/R SCCHN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CellSight Technologies, Inc.: lead
• Stanford University: collaborator

Study Sites (1)

Stanford Hospital and Clinics

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

BaseLine dental cement

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• A. Dimitrios Colevas, MD

  Stanford University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: April 26, 2017
• Study Start: May 1, 2017
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 5, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)