[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100463615":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":45,"responsibleParty":67,"collaborators":71,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":43,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":43,"enrollmentInfo":84,"targetDuration":43,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":47,"whyStopped":43,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Yale University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm B: Nivolumab","ACTIVE_COMPARATOR","Nivolumab will be administered at a dose of 240 mg IV day 1 and day 15. Treatment must be given on a Monday or Tuesday.\n\nNo premedication will be given. Patients will be observed following the initial dose of nivolumab per institutional Surgery will be scheduled in the period of day 16 through day 18.",[13],"Drug: Nivolumab",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm C: Combination 5-azacytidine and Nivolumab","EXPERIMENTAL","Patients will receive 5-azacytidine 75mg\u002Fm2 IV daily x 5. Treatment must begin on a Monday. 5-azacytidine will be given prior to nivolumab on day 2.\n\nPatients will receive anti-emetic premedication with prochlorperazine 10 mg IV, a 5HT3 antagonist per institutional guidelines, aprepitant or fos-aprepitant, and prn lorazepam on day 1. Day 2-5 patients will receive prochlorperazine 10 mg IV. Subsequent day 5HT3 antagonist therapy will be determined per institutional guidelines, as recommendations vary based on the half-life of the agent chosen. PRN lorazepam can be used days 2-5.\n\nNivolumab will be administered at a dose of 240 mg IV day 2 and day 16. No additional premedication will be given on day 16. Dexamethasone will be reserved for patients whose nausea and\u002For emesis is not controlled by the initial regimen. Surgery will be scheduled in the period of day 17 through day 18.",[19],"Drug: Combination 5-azacytidine and nivolumab",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Combination 5-azacytidine and nivolumab","The primary objective of the study is to determine whether exposure to the demethylating agent 5-azacytidine will sensitize HPV-associated oropharynx cancer to nivolumab by induction of interferon response, neoantigen expression, and augmentation of lymphocyte infiltration of the tumor microenvironment.",[15],[27],"Vidaza and Opdivo",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Nivolumab","Immunotherapy is a type of treatment that uses your body's own immune system to help fight cancer. Specifically, Nivolumab belongs to a class of anti-cancer drugs known as immune checkpoint inhibitors. Cancer cells are able to \"turn off\" the immune system by increasing the production of a protein called PD-1. Nivolumab can block PD-1 and may be able to re-activate the immune response to kill head and neck cancer cells.",[9],[33],"Opdivo",[35],{"name":36,"affiliation":5,"role":37},"Barbara Burtness, MD","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Carole Ramm","CONTACT","(203) 785-4095",null,"carole.ramm@yale.edu",[46],{"facility":5,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","New Haven","Connecticut","06511","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-72.92816,41.30815,{"lat":57,"lon":56},[60,63,66],{"name":61,"role":41,"phone":43,"phoneExt":43,"email":62},"Sharon Huie","sharon.huie@yale.edu",{"name":36,"role":41,"phone":64,"phoneExt":43,"email":65},"(203) 737-7636","barbara.burtness@yale.edu",{"name":36,"role":37,"phone":43,"phoneExt":43,"email":43},{"type":68,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"SPONSOR_INVESTIGATOR","Barbara Burtness","Professor of Medicine, Medical Oncology",[72],{"name":73,"class":74},"National Institute of Dental and Craniofacial Research (NIDCR)","NIH","100463615","phase-2-5-azacytidine-andor-nivolumab-in-resectable-hpv-associated-hnscc-100463615",false,"NCT05317000","5-Azacytidine and\u002For Nivolumab in Resectable HPV-Associated HNSCC","A Window Trial of 5-Azacytidine or Nivolumab or Combination Nivolumab Plus 5-Azacytidine in Resectable HPV-Associated Head and Neck Squamous Cell Cancer","Inclusion Criteria:\n\n1. Patients with resectable squamous cell carcinoma of the oropharynx. Histologic or cytologic confirmation from either a biopsy\u002Faspirate of the oropharyngeal primary lesion and\u002For a regional lymph node is required.\n2. T1-T3, N0-N2, M0 stage by AJCC 8th edition for HPV-initiated oropharynx cancer.\n3. Resectability confirmed by a surgical co-investigator; evaluation may include operative endoscopy to discover second primaries and map tumor extent with biopsy\n4. 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.\n5. HPV-association confirmed by institutional p16 testing (CINtec antibody demonstrating strong and diffuse nuclear and cytoplasmic staining in at least 70% of tumor cells).\n6. 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.\n7. ECOG performance status 0 or 1.\n8. Absolute neutrophil count (ANC) \\> 1500\u002Fmicroliter, absolute lymphocyte count (ALC) \\> 1000\u002Fmicroliter, hemoglobin \\> 9 g\u002Fdl, platelets \\> 100,000\u002Fmicroliter.\n9. AST and ALT \\\u003C 2.5 x upper limit of normal. Bilirubin \\\u003C 1.5 x upper limit of normal.\n10. Albumin \\> 3.0 g\u002Fdl.\n11. Creatinine \\\u003C 1.5 x upper limit of normal.\n12. Women of child-bearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL 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.\n13. 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\n\nExclusion Criteria:\n\n1. Medical contraindication to transoral surgery.\n2. Full dose anticoagulation.\n3. 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.\n4. Inability to give informed consent.\n5. Prior systemic therapy, radiation, or gross resection for the tumor under study.\n6. Women may not be pregnant or breast-feeding.\n7. Patients with active autoimmune disease, supraphysiologic systemic corticosteroid use within 7 days, and\u002For allergies\u002Fcontraindications to the study drugs are excluded.","ALL","18 Years",{"count":85,"type":86},50,"ESTIMATED","INTERVENTIONAL",[89],"PHASE2","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.\n\n5-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.",[92],"Squamous Cell Carcinoma of Head and Neck",[94],"HPV- Associated Head and Neck Squamous Cell Cancer","2026-06-08",{"date":97,"type":98},"2026-06-10","ACTUAL",{"date":100,"type":98},"2023-03-23",{"date":102,"type":86},"2028-11-30",{"name":69,"class":6},1]