Human papillomavirus and survival of patients with oropharyngeal cancer.
K Kian Ang, Jonathan Harris, Richard Wheeler...
https://pubmed.ncbi.nlm.nih.gov/20530316Actively 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
50
Participants Needed
1
Research Sites
21 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
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 system's 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 18 days depending on treatment arm
Participants receive pre-operative treatment with 5-azacytidine, nivolumab, or their combination before surgery.
2 to 3 visits (in-person) depending on treatment arm
Surgery
Duration - 3 days
Participants undergo surgical removal of the tumor following pre-operative treatment.
1 visit (in-person) scheduled between days 16 to 18 after treatment start
Trial Site Locations
Total: 1 location
1
Yale University
New Haven, Connecticut, United States, 06511
Actively Recruiting
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Research Team
C
Carole Ramm
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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Robert L Ferris, George Blumenschein, Jerome Fayette...
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Ezra E W Cohen, Denis Soulières, Christophe Le Tourneau...
https://pubmed.ncbi.nlm.nih.gov/30509740Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study.
Barbara Burtness, Kevin J Harrington, Richard Greil...
https://pubmed.ncbi.nlm.nih.gov/31679945Neoadjuvant immunotherapy with nivolumab and ipilimumab induces major pathological responses in patients with head and neck squamous cell carcinoma.
Joris L Vos, Joris B W Elbers, Oscar Krijgsman...
https://pubmed.ncbi.nlm.nih.gov/34937871Neoadjuvant and Adjuvant Pembrolizumab in Resectable Locally Advanced, Human Papillomavirus-Unrelated Head and Neck Cancer: A Multicenter, Phase II Trial.
Ravindra Uppaluri, Katie M Campbell, Ann Marie Egloff...
https://pubmed.ncbi.nlm.nih.gov/32665297Neoadjuvant Nivolumab or Nivolumab Plus Ipilimumab in Untreated Oral Cavity Squamous Cell Carcinoma: A Phase 2 Open-Label Randomized Clinical Trial.
Jonathan D Schoenfeld, Glenn J Hanna, Vickie Y Jo...
https://pubmed.ncbi.nlm.nih.gov/32852531APOBEC-induced mutations and their cancer effect size in head and neck squamous cell carcinoma.
Vincent L Cannataro, Stephen G Gaffney, Tomoaki Sasaki...
https://pubmed.ncbi.nlm.nih.gov/30647454TRAF3/CYLD mutations identify a distinct subset of human papillomavirus-associated head and neck squamous cell carcinoma.
Michael Hajek, Andrew Sewell, Susan Kaech...
https://pubmed.ncbi.nlm.nih.gov/28295222Comprehensive genomic characterization of head and neck squamous cell carcinomas.
Cancer Genome Atlas Network
https://pubmed.ncbi.nlm.nih.gov/25631445