Study of 5-Azacytidine and Nivolumab for HPV-Associated Head and Neck Cancer
This study is looking at how two drugs, 5-azacytidine (a chemotherapy) and nivolumab (an immunotherapy), work together to treat head and neck cancer linked to HPV. Researchers want to see if 5-azacytidine can make the cancer more sensitive to nivolumab. You might be able to join if you have resectable (meaning it can be removed by surgery) squamous cell carcinoma of the oropharynx (a part of the throat) that is HPV-associated. The study will measure if the combination treatment leads to a better immune response in the tumor compared to nivolumab alone. The current status of this study is unclear, and it plans to enroll 50 participants.
- Study design
- This is a Phase 2 study with three groups, where participants are randomly assigned to receive either nivolumab alone or nivolumab combined with 5-azacytidine before surgery.
- What's involved
- Participants will receive nivolumab on specific days, or 5-azacytidine daily for 5 days plus nivolumab, before having surgery within 16-18 days of starting treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome is measured at Day 16-18, which is when surgery occurs. Further follow-up is not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
5-Azacytidine and/or Nivolumab in Resectable HPV-Associated HNSCC
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Barbara Burtness, MD · PRINCIPAL_INVESTIGATOR · Yale University
Who to contact
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What this trial measures
- Increased response for combination therapy compared with either monotherapyDay 16-18
As assessed by the ir-PRC of Cottrell.