[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540678":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":88,"collaborators":25,"id":90,"slug":25,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":25,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":25,"enrollmentInfo":98,"targetDuration":25,"studyType":101,"phases":102,"briefSummary":105,"conditions":106,"keywords":109,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Theravectys S.A.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A : Refractory newly diagnosed","EXPERIMENTAL","Refractory recurrent and\u002For metastatic cervical or oropharyngeal cancer that is not amenable to local therapy with curative intent (ie, surgery or radiation therapy with or without chemotherapy).",[13],"Drug: Two IM injections Lenti-HPV-07",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm B : newly diagnosed locally advanced","Participants who have newly diagnosed locally advanced HPV-related oropharyngeal cancer (defined by AJCC 8th edition \\[ie, T1-2N2-N3, T3-T4N0-N3\\]) or cervical cancer (stages IB to IVA) that has never been treated with curative intent, and who are candidates to begin an SoC treatment (surgery, radiation therapy with or without chemotherapy).",[18],"Drug: One IM injection Lenti-HPV-07",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Two IM injections Lenti-HPV-07","two Lenti-HPV-07 intramuscular injections one month apart",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"One IM injection Lenti-HPV-07","a single intramuscular injection prior to receiving a standard of care 28 days at least after the injection.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Daniel Loera","CONTACT","713-256-8202","dloera@oncobay.com",[37,54,66,75],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Florida Cancer Specialists (from Sarah Canon research Institute)","RECRUITING","Orlando","Florida","32827","United States",{"type":45,"coordinates":46},"Point",[47,48],-81.37924,28.53834,{"lat":48,"lon":47},[51],{"name":52,"role":53,"phone":25,"phoneExt":25,"email":25},"Cesar Augusto Perez Batista, MD","PRINCIPAL_INVESTIGATOR",{"facility":55,"status":39,"city":56,"state":41,"zip":57,"country":43,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Tampa General Hospital","Tampa","33606",{"type":45,"coordinates":59},[60,61],-82.45843,27.94752,{"lat":61,"lon":60},[64],{"name":65,"role":53,"phone":25,"phoneExt":25,"email":25},"Noman Ashraf, MD",{"facility":67,"status":39,"city":56,"state":41,"zip":68,"country":43,"cosmosGeoPoint":69,"geoPoint":71,"contacts":72},"Moffitt Cancer Center","33612",{"type":45,"coordinates":70},[60,61],{"lat":61,"lon":60},[73],{"name":74,"role":53,"phone":25,"phoneExt":25,"email":25},"Guilherme Rabinowits, MD",{"facility":76,"status":39,"city":77,"state":78,"zip":79,"country":43,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Oklahoma Cancer Specialists and Research Institute, LLC","Tulsa","Oklahoma","74146",{"type":45,"coordinates":81},[82,83],-95.99277,36.15398,{"lat":83,"lon":82},[86],{"name":87,"role":53,"phone":25,"phoneExt":25,"email":25},"Daron Street, MD",{"type":89,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100540678",false,"NCT06319963","A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer","An Open-Label Phase 1\u002F2a Clinical Trial to Evaluate the Safety, Immunogenicity, and Preliminary Efficacy of a Lentiviral Vector-Based Therapeutic Vaccine Against Human Papilloma Virus (Lenti-HPV-07) in Participants With HPV-Associated Oropharyngeal Squamous Cell Cancer or Cervical Cancer","Inclusion Criteria:\n\n* histologically confirmed invasive HPV-related oropharyngeal or cervical cancer\n* ECOG performance status of 0 or 1\n* adequate hepatic, renal, pulmonary, and bone marrow\u002Fhematological function\n\nExclusion Criteria:\n\n\\- with seropositivity for HIV, active hepatitis C virus (HCV) infection, or hepatitis B (HBV) infection","ALL","18 Years",{"count":99,"type":100},72,"ESTIMATED","INTERVENTIONAL",[103,104],"PHASE1","PHASE2","The goal of this clinical trial is to learn about the safety and efficacy of a potential new treatment called Lenti-HPV-07 in patients with a cancer induced by Human Papilloma Virus (HPV).\n\nThe main questions aim to answer are:\n\n* Is Lenti-HPV-07 safe?\n* Does Lenti-HPV-07 induce an immune response?\n\nParticipants will be assigned to a group based on their cancer type\n\n* either study drug group A: recurrent and\u002For metastatic cancer\n* or study drug group B: newly diagnosed with locally advanced cancer\n\nAfter they finish the study treatment, they will be followed for up to 1 year. Follow-up visits will occur via clinic visits or phone calls 4 weeks after the last study treatment and then quarterly for up to 1 year.",[107,108],"HPV-Related Cervical Carcinoma","HPV Positive Oropharyngeal Squamous Cell Carcinoma",[110,111,112,113,114,115,116,117,118,119,120],"HPV16","Cervical Cancer","Oropharyngeal cancer","Immuno-oncotherapy","Head and Neck Cancers","T-cell vaccine","Lentiviral Vector","Anti-tumor immunity","Early E- and E7 antigens","HPV18","Human Papillomavirus","2026-01-29",{"date":123,"type":124},"2026-02-02","ACTUAL",{"date":126,"type":124},"2024-08-08",{"date":128,"type":100},"2026-12",{"name":5,"class":6},4]