Phase 2 Study Evaluating Nivolumab Alone or Combined with 5-Azacytidine Before Surgery in Treating Resectable HPV-Associated Head and Neck Squamous Cell Cancer

What this Trial Is About

Researchers are studying whether 5-azacytidine can make HPV-associated head and neck squamous cell cancer more responsive to treatment with nivolumab. This Phase 2 trial compares nivolumab alone versus a combination of 5-azacytidine and nivolumab given before surgery. Both drugs are FDA-approved for other cancers but are experimental when used together in this specific cancer type. Participants will be randomly assigned to receive either nivolumab alone or the combination treatment before surgery. Nivolumab is given intravenously on days 1 and 15 for the monotherapy group, while the combination group receives 5-azacytidine intravenously daily from days 1 to 5 and nivolumab on days 2 and 16. Surgery is scheduled shortly after treatment, between days 16 to 18 depending on the group. During the study, participants will undergo biopsies before and after treatment, and researchers will evaluate immune-related responses, tumor cell activity, and viral DNA levels. Safety and side effects will be monitored from the first treatment through 30 days after surgery. The study aims to better understand how these treatments affect the tumor and immune system, with total participation lasting several weeks from treatment start to surgery and follow-up assessments.

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