Study on 5-Azacytidine and/or Nivolumab for Treating Resectable HPV-Related Head and Neck Cancer
Sponsor: Barbara Burtness
ClinicalTrials ID:NCT05317000
This clinical trial is exploring whether the combination of two drugs, 5-azacytidine and nivolumab, can improve treatment outcomes for patients with HPV-related head and neck cancer that can be surgically removed.
Patient Parameters
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Program Overview
The purpose of this study is to see if using the chemotherapy drug 5-azacytidine along with the immunotherapy drug nivolumab can make HPV-related head and neck cancer more responsive to treatment. Both drugs are approved for use in other cancers, but their combined use in this type of cancer is considered experimental. The study will test the drugs either together or separately to evaluate their effectiveness.
Description
This Phase 2 study involves three groups of patients who will receive different treatments before surgery. One group will receive 5-azacytidine alone, another will receive nivolumab alone, and the third group will receive both drugs together. The main goal is to see how the immune system responds to these treatments by examining the cancer tissue after surgery. Researchers will also look at how the treatment affects the tumor environment and measure any changes in the cancer cells. Patients eligible for the study must have a specific type of head and neck cancer that can be surgically removed. They will receive the drugs through an IV, with surgery scheduled shortly after the treatment period. The study aims to enroll a total of 48 patients, with 8 receiving 5-azacytidine alone and 20 in each of the other two groups. The study will compare the effectiveness of the combination treatment against the individual treatments.
Eligibility Criteria
Inclusion Criteria
- Have a type of head and neck cancer that can be surgically removed, confirmed by medical tests.
- Cancer must be at a specific stage (T1-T3, N0-N2, M0) and associated with HPV.
- Surgery must be confirmed as possible by a specialist.
- Must provide tumor samples for research purposes.
- Cancer must be confirmed to be HPV-related through specific testing.
- Be over 18 years old, with no upper age limit if in good health.
- Both men and women can participate.
- Must be in good overall health, with a performance status of 0 or 1.
- Have adequate blood cell counts and organ function as determined by specific tests.
- Women of childbearing potential must have a negative pregnancy test before starting treatment.
- Must be willing and able to provide written informed consent for participation.
Exclusion Criteria
- Cannot have medical conditions that prevent surgery through the mouth.
- Cannot be on full-dose blood thinners.
- Cannot have another invasive cancer or a history of cancer within the last 2 years, except for certain types that are not currently active.
- Cannot have received prior treatment for the current cancer.
- Women cannot be pregnant or breastfeeding.
- Cannot have active autoimmune diseases or be on high doses of steroids recently.
- Cannot have allergies or contraindications to the study drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Yale University | 06511 | New Haven | Connecticut |
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