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

NCT03129061 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-12-05

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

Principal Investigators

  • A. Dimitrios Colevas, MD · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2022-12-01
Completion
2022-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03129061 on ClinicalTrials.gov