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Checkpoint Inhibitor
Treatment (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
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Event-free survival (EFS)
Incidence of treatment-emergent adverse events
Pathologic response
Secondary outcome measures
Association of biomarkers with pathological response status
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
~2720
Atezolizumab
2017
Completed Phase 3
~5860
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,421 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,123 Total Patients Enrolled
Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,637 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this medical study currently open to new participants?
"As indicated on clinicaltrials.gov, this particular research endeavor is actively searching for suitable candidates. The trial was initially disclosed on October 27th, 2023 and underwent the latest revision on March 18th, 2024."
Answered by AI
What is the overall safety profile of Atezolizumab for individuals?
"Based on the phase 2 trial status, Treatment (Atezolizumab) has been rated a safety score of 2 by our team at Power. This indicates that while there is existing data supporting its safety profile, efficacy data is still pending."
Answered by AI
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