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Study identifier: NCT05317000 Synced from ClinicalTrials.gov · August 06, 2026
● Study status: Recruiting

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

Condition: Squamous Cell Carcinoma of Head and Neck  ·  Sponsor: Barbara Burtness

PhasePhase 2
Planned participants50
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

This study is being done because both 5-azacytidine and nivolumab can influence the immune system's response to HPV-associated head and neck cancer, and we wish to evaluate whether taking 5-azacytidine will make HPV-associated head and neck cancer more sensitive to treatment with nivolumab. 5-Azacytidine (5-AZA) is a chemotherapy, and nivolumab is an immunotherapy. Both drugs are approved for use in the US by the Food and Drug Administration (FDA) for use in the treatment of different types of cancer, and nivolumab is approved for use in head and neck cancer that has previously been treated with chemotherapy. Because they are not approved to be used together in HPV-associated head and neck cancer, these drugs are considered experimental in this study. For this study, the drugs will be used either together or separately.

This description comes directly from the study's public registry record.

Talk to the study team

Carole Ramm  ·  (203) 785-4095  ·  carole.ramm@yale.edu

Always discuss trial participation with your own doctor first.

Locations (1)

Yale UniversityNew Haven, Connecticut, United StatesRecruiting

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