[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561395":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":28,"responsibleParty":45,"collaborators":20,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":20,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":20,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":31,"whyStopped":20,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"BlueSky Immunotherapies GmbH","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","FlubHPVE6E7",[13],"Biological: FluBHPVE6E7",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","FluBHPVE6E7","Intratumoral administration for first dose followed by intramuscular administration for subsequent doses at recommended dose level and determined schedule.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":26,"email":27},"Medical University of Vienna","CONTACT","+43140400","29800","klin-pharmakologie@meduniwien.ac.at",[29],{"facility":30,"status":31,"city":32,"state":20,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Medical University Vienna","RECRUITING","Vienna","1090","Austria","AT",{"type":37,"coordinates":38},"Point",[39,40],16.37208,48.20849,{"lat":40,"lon":39},[43],{"name":44,"role":24,"phone":25,"phoneExt":26,"email":27},"Department of Clinical Pharmacology",{"type":46,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100561395","phase-1-phase-1-clinical-trial-of-flubhpve6e7-immunotherapy-for-hpv16-associated-oropharyngeal-cancer-100561395",false,"NCT06589609","Phase 1 Clinical Trial of FluBHPVE6E7 Immunotherapy for HPV16-Associated Oropharyngeal Cancer","A Phase 1 Study of FluBHPVE6E7 Immunotherapy in Patients With HPV16- Associated Oropharyngeal Squamous Cell Carcinoma","Inclusion criteria:\n\n* Female or male patients, 18-65 years of age, with newly diagnosed, histologically confirmed p16- and HPV16-positive oropharyngeal squamous cell carcinoma with locoregional advanced disease including the following stages:\n\n  * T2N2-3, M0\n  * T3N0-3, M0\n  * T4N0-3, M0\n* Primary tumour accessible for biopsy and intratumoural administration\n* No evidence of distant metastatic disease (HPV16-positive secondary tumours are permissible)\n* Karnofsky 100 - 70 (ECOG 0 or 1)\n* Life expectancy of at least 6 months\n* Normal screening ECG or screening ECG with no clinically significant findings requiring immediate treatment, as judged by the investigator\n* Women of childbearing potential: Negative serum pregnancy test at screening\n* Agree to use a reliable form of contraception until the end of the study treatment period.\n* Provides written informed consent\n\nExclusion criteria:\n\n* Distant metastases\n* Secondary, not HPV16-associated, malignancy\n* History of malignancy other than the target malignancy to be investigated in this trial unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period\n* Clinically significant out of range haematological, renal or hepatic laboratory tests which cannot be explained by the underlying disease\n* Any vaccination within 1 week before day 0\n* Active significant viral infections including influenza, CMV, and EBV within 4 weeks before receiving study treatment\n* Co-infection with hepatitis B, hepatitis C, or HIV or having other immune deficient states\n* Influenza-like illness (ILI) within 4 weeks before day 0\n* Known hypersensitivity to Tamiflu or any of its components\n* Pregnancy, breastfeeding\n* Serious, concomitant disorder, including active systemic infection requiring treatment\n* Proven or suspected systemic lupus erythematosus, thyroiditis, inflammatory bowel disease including Crohn's disease or multiple sclerosis\n* Immunosuppression including any concurrent condition requiring the continued use of systemic steroids, or the use of immunosuppressive agents, disease modifying doses of anti-rheumatic drugs (e.g., azathioprine, cyclophosphamide, cyclosporine, methotrexate), and biologic disease modifying drugs such as TNF-α inhibitors (e.g. infliximab, adalimumab or etanercept). Corticosteroids must be discontinued \\> 4 weeks prior to day 0 of study medication administration. Eye drops or ear drops containing corticosteroids are permissible.\n* Prior major surgery within 4 weeks before day 0\n* Any current significant cardiac, hepatic or renal disease or history of clinically significant, medically unstable disease (e.g. chronic renal failure; angina, myocardial ischemia or infarction, congestive heart failure, cardiomyopathy, or clinically significant arrhythmias)\n* Participation in another experimental protocol\u002Fuse of investigational drug within two months before day 0\n* Any condition that, in the judgment of the investigator, might prevent safe participation in the study or interfere with study objectives\n* Unability to comply with the protocol requirements","ALL","18 Years","65 Years",{"count":58,"type":59},12,"ESTIMATED","INTERVENTIONAL",[62],"PHASE1","A clinical study of an immunotherapy in patients with head or neck cancers associated with the HPV16 virus",[65],"Oropharyngeal Squamous Cell Carcinoma (SCC)",[67,68,69,70,71,72],"immunotherapy","Oropharyngal squamous cell carcinoma","HPV-16","Human papilloma virus","cancer","Head and neck cancer","2024-09-06",{"date":75,"type":76},"2024-09-19","ACTUAL",{"date":78,"type":76},"2024-08-23",{"date":80,"type":59},"2029-11",{"name":5,"class":6},1]