Actively Recruiting
5-Azacytidine and/or Nivolumab in Resectable HPV-Associated HNSCC
Led by Barbara Burtness · Updated on 2026-01-12
50
Participants Needed
1
Research Sites
297 weeks
Total Duration
On this page
Sponsors
B
Barbara Burtness
Lead Sponsor
N
National Institute of Dental and Craniofacial Research (NIDCR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
5-Azacytidine and/or Nivolumab in Resectable HPV-Associated HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with resectable squamous cell carcinoma of the oropharynx confirmed by biopsy or cytology
- Tumor stage T1-T3, N0-N2, M0 according to AJCC 8th edition for HPV-associated oropharynx cancer
- Resectability confirmed by a surgical co-investigator
- Required biopsies of primary tumor tissue for research equal or greater than three 3mm cup forceps biopsies
- HPV-association confirmed by institutional p16 testing showing strong staining in at least 70% of tumor cells
- Age 18 years or older with no upper age limit if performance status is adequate
- Both males and females are eligible
- ECOG performance status of 0 or 1
- Adequate blood counts: ANC ≥1500/microliter, ALC ≥1000/microliter, hemoglobin ≥9 g/dl, platelets ≥100,000/microliter
- Liver function: AST and ALT less than 2.5 times upper limit of normal, bilirubin less than 1.5 times upper limit
- Albumin level ≥3.0 g/dl
- Creatinine less than or equal to 1.5 times upper limit of normal
- Women of child-bearing potential must have a negative pregnancy test within 24 to 72 hours prior to study treatment start
- Willing and able to provide written informed consent
You will not qualify if you...
- Medical contraindication to transoral surgery
- Use of full dose anticoagulation
- Having another invasive cancer or cancer within the past 2 years except certain exceptions like hormonally responsive breast or prostate cancer, resected non-melanoma skin cancer, resected uterine cervical carcinoma, or meningioma
- Unable to give informed consent
- Prior systemic therapy, radiation, or major surgery for the current tumor
- Pregnant or breastfeeding women
- Active autoimmune disease, use of high-dose corticosteroids within 7 days, or allergies/contraindications to study drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Yale University
New Haven, Connecticut, United States, 06511
Actively Recruiting
Research Team
C
Carole Ramm
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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