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PD-1 Inhibitor

[18F]F-AraG PET Scan, baseline + post anti-PD-1 therapy. for Squamous Cell Carcinoma

Phase 1
Waitlist Available
Research Sponsored by CellSight Technologies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 to 3 weeks post initial anti-pd-1 dose.
Awards & highlights

Study Summary

This trial is studying a new imaging technique and biomarkers in people with head and neck cancer that has spread or cannot be removed by surgery.

Eligible Conditions
  • Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 to 3 weeks post initial anti-pd-1 dose.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 to 3 weeks post initial anti-pd-1 dose. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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
Secondary outcome measures
Success rate for collection of paired blood and tissue samples pre and post immunotherapy treatment in each Cohort.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2 Patients with de novo SCCHNExperimental Treatment1 Intervention
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.
Group II: Cohort 1 Patients with M/R SCCHNExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
[18F]F-AraG PET Scan, baseline + post anti-PD-1 therapy.
2017
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

CellSight Technologies, Inc.Lead Sponsor
17 Previous Clinical Trials
296 Total Patients Enrolled
Stanford UniversityOTHER
2,387 Previous Clinical Trials
17,334,035 Total Patients Enrolled
A. Dimitrios Colevas, MDStudy DirectorStanford University
5 Previous Clinical Trials
58 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate Immunological Response to PD-1 Inhibition in Squamous Cell Carcinoma of the Head and Neck (SCCHN)
2017. "Study to Evaluate Immunological Response to PD-1 Inhibition in Squamous Cell Carcinoma of the Head and Neck (SCCHN)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03129061.
~2 spots leftby Apr 2025
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