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.

NCT05317000

5-Azacytidine and/or Nivolumab in Resectable HPV-Associated HNSCC

Recruiting
PHASE2Ages 18+InterventionalTreatment
Barbara Burtness
~50 participants
Updated 2026-06-10 on ClinicalTrials.gov
What's tested:Combination 5-azacytidine and nivolumabNivolumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Increased response for combination therapy compared with either monotherapy
Measured over Day 16-18
Squamous Cell Carcinoma of Head and Neck
1 sites across 1 states
Connecticut1
  • Barbara Burtness, MD · PRINCIPAL_INVESTIGATOR · Yale University

Opens a ready-to-send draft in your own email app — review before sending.

  • Increased response for combination therapy compared with either monotherapyDay 16-18

    As assessed by the ir-PRC of Cottrell.