What is this study testing for in HPV-associated head and neck cancer?

This study is testing whether combining 5-azacytidine with nivolumab improves the immune system's response to HPV-associated head and neck cancer. It compares the effects of each drug alone and in combination to see if the cancer becomes more sensitive to treatment. The research aims to better understand treatment options for this cancer type under the guidance of Barbara Burtness.

Who may be eligible for this HPV-associated head and neck cancer clinical trial?

Adults aged 18 and older with HPV-positive squamous cell carcinoma of the oropharynx that can be surgically removed may be eligible. Both men and women can participate if they have not had prior treatment for this tumor, have a good overall health status, and no active autoimmune disease. Please review eligibility criteria for more details.

Is there any cost to participate in this HPV-associated head and neck cancer clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID05317000

A Window Trial of 5-Azacytidine, Nivolumab, or Their Combination in Resectable HPV-Associated Head and Neck Squamous Cell Carcinoma

Led by Barbara Burtness · Updated on 2026-01-12

Participants Needed

Research Sites

21 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of 5-azacytidine and nivolumab, alone or combined, on HPV-associated head and neck squamous cell carcinoma that can be surgically removed. This Phase 2 trial aims to see if adding 5-azacytidine can make the cancer more responsive to treatment with nivolumab by boosting the immune systems attack on the tumor. The study focuses on patients with specific stages of oropharynx cancer confirmed to be HPV-related and involves measuring immune-related responses in the tumor tissue. Participants are randomly assigned to one of three groups 5-azacytidine alone, nivolumab alone, or both drugs combined. 5-azacytidine is given intravenously once daily for five days starting on a Monday, with anti-nausea premedication. Nivolumab is administered intravenously twice, either on days 1 and 15 for the nivolumab group or days 2 and 16 for the combination group. Surgery is scheduled shortly after treatment, between days 16 and 18 for the monotherapy groups and days 17 to 18 for the combination group. During the study, patients undergo biopsies before and after treatment to assess tumor response and immune activity. Researchers measure immune-related pathologic response, tumor infiltration by immune cells, tumor size changes, and treatment toxicity. Safety is monitored from the first treatment through 30 days after surgery. Participants provide informed consent and must meet specific health criteria to join. The total involvement includes treatment, surgery, and follow-up assessments to evaluate the treatment effects.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Patients with resectable squamous cell carcinoma of the oropharynx confirmed by biopsy or cytology
Tumor stage T1 to T3, N0 to N2, M0 according to AJCC 8th edition for HPV-related oropharynx cancer
Resectability confirmed by a surgical specialist
Ability to provide tumor tissue samples for research
HPV association confirmed by p16 protein testing
Age 18 years or older
Both males and females are eligible
ECOG performance status of 0 or 1
Adequate blood counts and organ function as defined by specific laboratory values
Negative pregnancy test for women of child-bearing potential
Willing and able to provide written informed consent

You will not qualify if you...

Medical reasons that prevent transoral surgery
Use of full dose blood thinners (anticoagulation)
Having another invasive cancer within the past 2 years except certain treated cancers
Inability to give informed consent
Prior systemic therapy, radiation, or major surgery for the tumor under study
Pregnancy or breastfeeding
Active autoimmune disease or allergies to study drugs
Use of high-dose steroids within 7 days before treatment

Research Team

Carole Ramm

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