OncoMatch/Clinical Trials/NCT05317000
5-Azacytidine and/or Nivolumab in Resectable HPV-Associated HNSCC
Is NCT05317000 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Combination 5-azacytidine and nivolumab and 5-azacytidine for squamous cell carcinoma of head and neck.
Treatment: Combination 5-azacytidine and nivolumab · 5-azacytidine · Nivolumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: HPV association confirmed by p16 overexpression (CINtec antibody, strong and diffuse nuclear and cytoplasmic staining in at least 70% of tumor cells) (strong and diffuse nuclear and cytoplasmic staining in at least 70% of tumor cells)
HPV-association confirmed by institutional p16 testing (CINtec antibody demonstrating strong and diffuse nuclear and cytoplasmic staining in at least 70% of tumor cells)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
Prior systemic therapy ... for the tumor under study
Cannot have received: radiation therapy
Prior ... radiation ... for the tumor under study
Cannot have received: surgery
Exception: gross resection only
Prior ... gross resection for the tumor under study
Lab requirements
Blood counts
ANC >= 1500/microliter, ALC >= 1000/microliter, hemoglobin >= 9 g/dl, platelets >= 100,000/microliter.
Kidney function
Creatinine <= 1.5 x upper limit of normal.
Liver function
AST and ALT < 2.5 x upper limit of normal. Bilirubin < 1.5 x upper limit of normal.
ANC >= 1500/microliter, ALC >= 1000/microliter, hemoglobin >= 9 g/dl, platelets >= 100,000/microliter. AST and ALT < 2.5 x upper limit of normal. Bilirubin < 1.5 x upper limit of normal. Albumin >= 3.0 g/dl. Creatinine <= 1.5 x upper limit of normal.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Yale University · New Haven, Connecticut
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