5-Azacytidine and/or Nivolumab in Resectable HPV-Associated HNSCC (NCT05317000)
A Window Trial of 5-Azacytidine or Nivolumab or Combination Nivolumab Plus 5-Azacytidine in Resectable HPV-Associated Head and Neck Squamous Cell Cancer
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Yale University — New Haven, Connecticut
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Yale University — New Haven, Connecticut
📞 Contact the Study Coordinator
Phone: (203) 785-4095
Email: carole.ramm@yale.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Squamous Cell Carcinoma of Head and Neck
- Pembrolizumab Plus Olaparib in LA-HNSCC — Indianapolis, Indiana
- TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC — Tampa, Florida
- HYPORT: A Phase I/II Study of Hypofractionated Post-operative Radiation Therapy for Head and Neck Cancer — Dallas, Texas
- MicroRNA Markers in Head and Neck Cancers — Aurora, Colorado
- A Clinical Trial Evaluating TG4050 in Head and Neck Cancer — Jacksonville, Florida
- A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer — La Jolla, California
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.