[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540678":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":89,"collaborators":25,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":25,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":25,"enrollmentInfo":100,"targetDuration":25,"studyType":103,"phases":104,"briefSummary":107,"conditions":108,"keywords":111,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"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",[37,55,67,76],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Florida Cancer Specialists (from Sarah Canon research Institute)","RECRUITING","Orlando","Florida","32827","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-81.37924,28.53834,{"lat":49,"lon":48},[52],{"name":53,"role":54,"phone":25,"phoneExt":25,"email":25},"Cesar Augusto Perez Batista, MD","PRINCIPAL_INVESTIGATOR",{"facility":56,"status":39,"city":57,"state":41,"zip":58,"country":43,"countryCode":44,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Tampa General Hospital","Tampa","33606",{"type":46,"coordinates":60},[61,62],-82.45843,27.94752,{"lat":62,"lon":61},[65],{"name":66,"role":54,"phone":25,"phoneExt":25,"email":25},"Noman Ashraf, MD",{"facility":68,"status":39,"city":57,"state":41,"zip":69,"country":43,"countryCode":44,"cosmosGeoPoint":70,"geoPoint":72,"contacts":73},"Moffitt Cancer Center","33612",{"type":46,"coordinates":71},[61,62],{"lat":62,"lon":61},[74],{"name":75,"role":54,"phone":25,"phoneExt":25,"email":25},"Guilherme Rabinowits, MD",{"facility":77,"status":39,"city":78,"state":79,"zip":80,"country":43,"countryCode":44,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Oklahoma Cancer Specialists and Research Institute, LLC","Tulsa","Oklahoma","74146",{"type":46,"coordinates":82},[83,84],-95.99277,36.15398,{"lat":84,"lon":83},[87],{"name":88,"role":54,"phone":25,"phoneExt":25,"email":25},"Daron Street, MD",{"type":90,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100540678","phase-1-a-study-to-evaluate-lenti-hpv-07-immunotherapy-against-hpv-cervical-or-oropharyngeal-cancer-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":101,"type":102},72,"ESTIMATED","INTERVENTIONAL",[105,106],"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.",[109,110],"HPV-Related Cervical Carcinoma","HPV Positive Oropharyngeal Squamous Cell Carcinoma",[112,113,114,115,116,117,118,119,120,121,122],"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":125,"type":126},"2026-02-02","ACTUAL",{"date":128,"type":126},"2024-08-08",{"date":130,"type":102},"2026-12",{"name":5,"class":6},4]