NCT05317000 5-Azacytidine and/or Nivolumab in Resectable HPV-Associated HNSCC
| NCT ID | NCT05317000 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Barbara Burtness |
| Condition | Squamous Cell Carcinoma of Head and Neck |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-03-23 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2023-03-23 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Patients with resectable squamous cell carcinoma of the oropharynx. Histologic or cytologic confirmation from either a biopsy/aspirate of the oropharyngeal primary lesion and/or a regional lymph node is required. 2. T1-T3, N0-N2, M0 stage by AJCC 8th edition for HPV-initiated oropharynx cancer. 3. Resectability confirmed by a surgical co-investigator; evaluation may include operative endoscopy to discover second primaries and map tumor extent with biopsy 4. In addition to diagnostic biopsies, biopsies in clinic or at the time of operative endoscopy are required to yield primary tumor for research purposes \> 3mm cup forceps biopsies X 3. Prior biopsies for research obtained with informed consent for the Yale Biosample Repository Protocol are acceptable if they meet the volume requirements above. 5. HPV-association confirmed by institutional p16 testing (CINtec antibody demonstrating strong and diffuse nuclear and cytoplasmic staining in at least 70% of tumor cells). 6. Age \> 18 years. 5-azacytidine and nivolumab are tolerated in the elderly and there is no upper age limit for patients with adequate performance status. 7. ECOG performance status 0 or 1. 8. Absolute neutrophil count (ANC) \> 1500/microliter, absolute lymphocyte count (ALC) \> 1000/microliter, hemoglobin \> 9 g/dl, platelets \> 100,000/microliter. 9. AST and ALT \< 2.5 x upper limit of normal. Bilirubin \< 1.5 x upper limit of normal. 10. Albumin \> 3.0 g/dl. 11. Creatinine \< 1.5 x upper limit of normal. 12. Women of child-bearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study treatment. An extension up to 72 hours prior to the start of study treatment is permissible in situations where results cannot be obtained within the standard 24-hour window. 13. Willing and able to provide written informed consent. Informed consent is required prior to research-related activities, including biopsy. However, if written informed consent for participation in the biosample repository protocol has been obtained, tissue obtained under that consent can be used to meet eligibility criterion Exclusion Criteria: 1. Medical contraindication to transoral surgery. 2. Full dose anticoagulation. 3. Concomitant invasive malignancy, or malignancy within 2 years except for hormonally responsive breast or prostate cancer, resected non-melanoma skin cancer, resected uterine cervical carcinoma or meningioma. 4. Inability to give informed consent. 5. Prior systemic therapy, radiation, or gross resection for the tumor under study. 6. Women may not be pregnant or breast-feeding. 7. Patients with active autoimmune disease, supraphysiologic systemic corticosteroid use within 7 days, and/or allergies/contraindications to the study drugs are excluded.
Contact & Investigator
Barbara Burtness, MD
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT05317000 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Squamous Cell Carcinoma of Head and Neck. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05317000 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05317000 currently recruiting?
Yes, NCT05317000 is actively recruiting participants. Contact the research team at carole.ramm@yale.edu for enrollment information.
Where is the NCT05317000 trial being conducted?
This trial is being conducted at New Haven, United States.
Who is sponsoring the NCT05317000 clinical trial?
NCT05317000 is sponsored by Barbara Burtness. The principal investigator is Barbara Burtness, MD at Yale University. The trial plans to enroll 50 participants.