[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"BlueSky Immunotherapies GmbH\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100503005","phase-1-phase-1-dose-escalation-study-of-flubhpve6e7-in-hpv16-infected-women-100503005",false,"NCT05829629","Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women","Randomised, Double-blind, Placebo-controlled Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women with NILM, ASC-US, LSIL or Low-grade CIN","Inclusion Criteria:\n\n* Females, 18-49 years of age with HPV16 infection and cervical cytological evaluation negative for intraepithelial lesion or malignancy (NILM), atypical squamous cells of undetermined significance (ASC-US), low grade squamous intraepithelial lesion (LSIL), or low-grade cervical intraepithelial neoplasia (CIN1)\n* HPV16 infection has been confirmed at least twice by a validated HPV test separated by at least 3 months\n* Satisfactory colposcopy\n* No clinically significant out of range haematological, renal or hepatic laboratory tests\n* Normal screening ECG or screening ECG with no clinically significant findings, as judged by the investigator\n* Negative serum pregnancy test at screening\n* Agree to use a reliable form of contraception during the whole study period.\n* Provides written informed consent\n\nExclusion Criteria:\n\n* Any vaccination within 6 weeks of day 0\n* Active significant viral infections including influenza, CMV, and EBV within 30 days of receiving study treatment\n* Co-infection with hepatitis B, hepatitis C, or HIV or having other immune deficient states\n* Current Bacterial Vaginosis (BV) infection\n* Current high-grade cervical intraepithelial neoplasia (CIN2\u002F3)\n* Prior history of or current malignancy, vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VAIN), atypical glandular cells (AGC), adenocarcinoma in situ (AIS) or any suspicion of either micro-invasive or invasive disease\n* Pregnancy, breastfeeding\n* Influenza-like illness (ILI) within 3 months of day 0\n* Known hypersensitivity to oseltamivir or any of its components\n* Any anatomical condition of the cervix, including that resulting from previous cervical surgery, congenital malformation or other condition, that would interfere with a complete evaluation of the cervix\n* Current pelvic inflammatory disease, cervicitis, or other gynaecological infection as per colposcopy and clinical examination\n* Serious, concomitant disorder, including active systemic infection requiring treatment\n* Presence of acute or chronic bleeding or clotting disorder, or use of blood thinners within 2 weeks of day 0\n* A proven or suspected autoimmune disease\n* Immunosuppression including any concurrent condition requiring the continued use of systemic or topical steroids, or the use of immunosuppressive agents, disease modifying doses of anti-rheumatic drugs, and biologic disease modifying drugs. Any immunosuppressive agents containing corticosteroids or monoclonal antibodies specific for the treatment of obstructive airway, ear or vestibular diseases are permissible.\n* Acute or history of Herpes genitalis\n* Prior major surgery within 4 weeks of day 0\n* Administration of any blood product within 3 months of enrolment\n* Any current significant cardiac, hepatic or renal disease or history of clinically significant, medically unstable disease\n* Any current or history of neurological disease including history of seizures\n* Participation in another experimental protocol\u002Fuse of investigational drug during the prior two months","FEMALE","18 Years","49 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","BS-02 is a randomised, double-blind, placebo-controlled, phase 1 dose escalation study to assess the safety, tolerability and immunogenicity of FluBHPVE6E7, in women infected with HPV-16. with cervical cytological evaluation negative for intraepithelial lesion or malignancy (NILM), atypical squamous cells of undetermined significance (ASC-US), low grade squamous intraepithelial lesion (LSIL), or low-grade cervical intraepithelial neoplasia (CIN1).",[27,28],"HPV Infection","HPV-Related Cervical Carcinoma","RECRUITING","2025-02-12",{"date":32,"type":33},"2025-02-14","ACTUAL",{"date":35,"type":33},"2023-09-12",{"date":37,"type":21},"2025-11",{"name":39,"class":40},"BlueSky Immunotherapies GmbH","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":49,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":41},"100561395","phase-1-phase-1-clinical-trial-of-flubhpve6e7-immunotherapy-for-hpv16-associated-oropharyngeal-cancer-100561395","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","65 Years",{"count":52,"type":21},12,[24],"A clinical study of an immunotherapy in patients with head or neck cancers associated with the HPV16 virus",[56],"Oropharyngeal Squamous Cell Carcinoma (SCC)",[58,59,60,61,62,63],"immunotherapy","Oropharyngal squamous cell carcinoma","HPV-16","Human papilloma virus","cancer","Head and neck cancer","2024-09-06",{"date":66,"type":33},"2024-09-19",{"date":68,"type":33},"2024-08-23",{"date":70,"type":21},"2029-11",{"name":39,"class":40},""]