Pre-operative Atezolizumab for Treating Resectable HPV-Related Throat Cancer
Sponsor: Emory University
ClinicalTrials ID:NCT06254911
This clinical trial is exploring the use of atezolizumab, an immunotherapy drug, to treat patients with HPV-related throat cancer that can be surgically removed. The study aims to see if this treatment can help the body's immune system fight the cancer more effectively.
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Program Overview
This phase II study is testing how well the drug atezolizumab works in patients with HPV-related throat cancer that can be removed with surgery. Atezolizumab is an immunotherapy that may help the immune system stop cancer cells from growing and spreading.
Description
The main goals of this study are to determine if two doses of atezolizumab are safe and effective in treating HPV-related throat cancer. Researchers will also look at how the cancer responds to the treatment and whether patients remain cancer-free two years after treatment.
The study will also explore how atezolizumab affects certain markers in the blood and tissue, which may help predict who will respond well to the treatment. Patients will receive atezolizumab through an IV and may have scans and biopsies to monitor their progress.
Participants must be at least 18 years old and agree to use birth control during the study. They must have a confirmed diagnosis of HPV-related throat cancer that can be surgically removed and meet other health criteria. Patients with certain health conditions, such as autoimmune diseases or active infections, may not be eligible.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must agree to use birth control during the study and for 5 months after the last dose.
- Women must not be pregnant and must have a negative pregnancy test before starting treatment.
- Must have a confirmed diagnosis of HPV-related throat cancer that can be surgically removed.
- Must not have extensive or fixed lymph node involvement.
- Must have had recent imaging tests to assess the cancer.
- Must be able to understand and agree to the study requirements.
- Must not have had prior radiation treatment above the collarbone.
- Must have good overall health and meet specific blood test criteria.
- Must not have active infections like HIV or hepatitis unless well-controlled.
Exclusion Criteria
- Cannot have untreated or progressing brain cancer.
- Cannot have a history of certain autoimmune diseases unless well-controlled.
- Cannot have active lung diseases or infections like tuberculosis.
- Cannot have uncontrolled pain or fluid buildup in the body.
- Cannot have had a severe infection or major surgery recently.
- Cannot have had other cancers unless treated and disease-free for at least a year.
- Cannot have had a stem cell or organ transplant.
- Cannot be pregnant or breastfeeding.
- Cannot have severe allergies to the study drug or its components.
- Cannot have received certain vaccines or treatments recently.
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