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Trial record 2 of 5 for:    cellsight

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

This study is currently recruiting participants.
Verified May 2017 by CellSight Technologies, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03129061
First Posted: April 26, 2017
Last Update Posted: May 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Stanford University
Information provided by (Responsible Party):
CellSight Technologies, Inc.
  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

Condition Intervention Phase
Squamous Cell Carcinoma of the Head and Neck Drug: [18F]F-AraG PET Scan, baseline + post anti-PD-1 therapy. Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study to Evaluate Immunological Response to PD-1 Inhibition in Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Resource links provided by NLM:


Further study details as provided by CellSight Technologies, Inc.:

Primary Outcome Measures:
  • 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. ]
    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:
  • 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. ]
    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.


Estimated Enrollment: 24
Anticipated Study Start Date: May 2017
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1 Patients with M/R SCCHN
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.
  • 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.
Experimental: Cohort 2 Patients with de novo SCCHN
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.
  • Baseline: Blood sampling, tumor biopsy, [18F]F-AraG PET/CT scan within two weeks prior to treatment.
  • Anti PD-1, single dose
  • Blood sampling, tumor biopsy and [18F}F-AraG PET/CT scan within 2-3 weeks after single dose of anti-PD-1 treatment. For patients having surgical resection, biopsy will be immediately prior to resection or from sample of resection.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03129061


Contacts
Contact: Stefania U Chirita 650-723-1423 schirita@stanford.edu
Contact: Tookie A May 650-721-4079 mmay2@stanford.edu

Locations
United States, California
Stanford Hospital and Clinics Recruiting
Stanford, California, United States, 94305
Contact: Stefania U Chirita    650-723-1423    schirita@stanford.edu   
Contact: Tookie A May    650-721-4079    mmay2@stanford.edu   
Sponsors and Collaborators
CellSight Technologies, Inc.
Stanford University
Investigators
Study Director: A. Dimitrios Colevas, MD Stanford University
  More Information

Responsible Party: CellSight Technologies, Inc.
ClinicalTrials.gov Identifier: NCT03129061     History of Changes
Other Study ID Numbers: 40425
ENT0061 ( Other Identifier: Stanford University )
First Submitted: April 18, 2017
First Posted: April 26, 2017
Last Update Posted: May 10, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site