Study on Pembrolizumab for Treating Recurrent Squamous Cell Cancer of the Head and Neck
Sponsor: Assuntina G. Sacco, MD
ClinicalTrials ID:NCT02769520
This clinical trial is testing whether pembrolizumab, given after surgery, can help people with recurrent squamous cell cancer of the head and neck stay disease-free for longer.
Patient Parameters
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Program Overview
The study aims to find out if pembrolizumab, a medication given after surgery, can extend the time patients with recurrent squamous cell cancer of the head and neck remain free of the disease. It involves 45 participants and will measure how many remain disease-free after one year. The study will also look at survival rates, side effects, and how the immune system responds to the treatment. Participants will be randomly assigned to receive pembrolizumab or a placebo before surgery, and samples will be collected for further analysis.
Description
This study is designed to see if pembrolizumab, given after surgery, can help people with recurrent squamous cell cancer of the head and neck stay disease-free for longer. It is a phase II study involving 45 patients who will receive pembrolizumab after surgery to see if it increases the time they remain free of cancer. The study will also look at survival rates, side effects, and how the immune system responds to the treatment. Before surgery, participants will be randomly assigned to receive either pembrolizumab or a placebo. Tumor and blood samples will be collected during surgery for further analysis.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with squamous cell cancer of the head and neck that has come back locally.
- Had a period of at least 16 weeks without disease after initial treatment.
- Eligible for surgery to remove the cancer.
- Able to provide a tissue sample from a tumor biopsy.
- Have good organ function.
- Women of childbearing age must have a negative pregnancy test before starting the study and agree to use birth control.
- Men with partners of childbearing age must agree to use contraception during the study and for 120 days after the last dose.
Exclusion Criteria
- Have nasopharyngeal carcinoma.
- Have cancer that has spread to other parts of the body.
- Have received another experimental treatment within 4 weeks before starting the study.
- Have an immune deficiency or are taking immune-suppressing medications.
- Have a history of active tuberculosis.
- Have received certain cancer treatments recently and not fully recovered from side effects.
- Have had major surgery recently and not fully recovered.
- Have another active cancer that needs treatment.
- Have active brain cancer or meningitis.
- Have an autoimmune disease needing treatment in the past 2 years.
- Have a history of lung inflammation.
- Are pregnant or breastfeeding.
- Have received certain immunotherapies recently.
- Have active hepatitis B, hepatitis C, or HIV.
- Have interstitial lung disease.
- Are suitable for radiation therapy after surgery.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UCSD Moores Cancer Center | 92093 | La Jolla | California |
| University of California San Francisco | 94115 | San Francisco | California |
| University of California Los Angeles | 90505 | Torrance | California |
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