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

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 w

Trial Details

NCT ID
NCT05317000
Phase
PHASE2
Sponsor
Barbara Burtness
Status
RECRUITING
Cancer Type
Head and Neck Cancer
Interventions
  • Combination 5-azacytidine and nivolumab
  • Nivolumab
Locations (sample)
  • New Haven, Connecticut, United States|41.30815,-72.92816

Key Eligibility Criteria

  • Patients with resectable squamous cell carcinoma of the oropharynx. Histologic or cytologic confirmation from either a biopsy/aspirate of the oroph…
  • T1-T3, N0-N2, M0 stage by AJCC 8th edition for HPV-initiated oropharynx cancer.
  • Resectability confirmed by a surgical co-investigator; evaluation may include operative endoscopy to discover second primaries and map tumor extent…
  • In addition to diagnostic biopsies, biopsies in clinic or at the time of operative endoscopy are required to yield primary tumor for research purpo…

For full eligibility, visit ClinicalTrials.gov.

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