A Window Trial of 5-Azacytidine or Nivolumab or Combination Nivolumab Plus 5-Azacytidine in Resectable HPV-Associated Head and Neck Squamous Cell Cancer
Volunteers
Health Professionals
What is the purpose of this trial?
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.
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Principal Investigator
Sub-Investigators
- Aarti Bhatia, MD, MPH
- Andrea Brennan
- Ansley Roche, MD, BA
- Avanti Verma, MD
- Benjamin Newton, MD
- Benjamin L. Judson, MD, MBA
- Harold Tara Jr, MD
- Jason Haldas, MD
- Lynsey Teulings
- Manju Prasad, MD, MBBS
- Matthew Austin, MD
- Michael Chiorazzi, MD, PhD
- Neal Fischbach, MD
- Renee Moye
- Robert Legare, MD
- Saral Mehra, MD, MBA, FACS
- Stephen Lattanzi, MD
- Last Updated08/16/2024
- Study HIC#2000025632