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Checkpoint Inhibitor

Atezolizumab for Throat Cancer

Phase 2

Recruiting

Led By Mihir R Patel, MD

Research Sponsored by Emory University

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 up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a drug called atezolizumab to see how well it works in treating a specific type of throat cancer caused by the HPV virus that can be removed with surgery. A

Who is the study for?

This trial is for adults over 18 with HPV-related oropharyngeal squamous cell carcinoma that can be surgically removed. Participants must not be pregnant, agree to use contraception, and have no extensive neck lymph node involvement. Those with prior radiation above the clavicles or certain other cancers within two years are excluded.

What is being tested?

The study tests Atezolizumab's effectiveness before surgery in patients with resectable HPV-related throat cancer. It examines how this immunotherapy might affect the immune system's response to tumor cells and their ability to spread.

What are the potential side effects?

Atezolizumab may cause side effects related to immune system changes such as inflammation in organs, fatigue, infusion reactions (like fever or chills), and possibly increased risk of infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Event-free survival (EFS)

Pathologic response

Secondary study objectives

Association of biomarkers with pathological response status

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (Atezolizumab)Experimental Treatment4 Interventions

Patients receive atezolizumab IV while on study. Patients undergo CT scan and MRI throughout the study. Patients may undergo tumor biopsy while on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2790

Atezolizumab

2016

Completed Phase 3

~5860