[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"human-papillomavirus-viruses\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:human-papillomavirus-viruses":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100533265","phase-2-phase-ii-trial-of-neoadjuvant-chemotherapy-nac-alone-or-in-combination-with-immunotherapy-vaccine-prgn-2009-in-subjects-with-newly-diagnosed-hpv-associated-oropharyngeal-head-and-neck-cancer-100533265",false,"NCT06223568","Phase II Trial of Neoadjuvant Chemotherapy (NAC) Alone or in Combination With Immunotherapy Vaccine PRGN-2009 in Subjects With Newly Diagnosed HPV-Associated Oropharyngeal (Head and Neck) Cancer","* INCLUSION CRITERIA:\n* Histologically or cytologically confirmed surgically resectable newly diagnosed stage I (cT1-2, N0-1) or II (T1-3, N0-2), M0 oropharyngeal squamous cell carcinoma. Note: Pathological report of cancer diagnosis may be from the primary tumor or from a metastatic cervical lymph node.\n* History of HPV-positive status determined by a standard-of-care HPV testing. Note: All participants with high-risk HPV serotypes are eligible.\n* Age \\>= 18 years.\n* ECOG performance status \\\u003C= 2.\n* Individuals who smoke currently must smoke \\\u003C10 pack years. Note: Former smokers with any pack-year history are eligible if quit smoking \\>10 years before study treatment initiation. Former smokers who quit \\\u003C10 years before study treatment initiation must have smoked \\\u003C10 pack years.\n* Planned for cancer removal surgery per standard of care (SOC) and individual had agreed for the cancer removal surgery.\n\n  * Individuals must have adequate organ and marrow function as defined below:\n  * Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^9\u002FL\n  * Hemoglobin (Hgb) \\>= 9.0 g\u002FdL\n  * Platelet count \\>= 100 x 10\\^9\u002FL\n  * Creatinine \\\u003C= 1.2 x upper limit of normal (ULN) OR calculated creatinine clearance \\>=55 mL\u002Fmin\u002F1.73m\\^2 by Cockcroft-Gault formula\n* Total bilirubin \\\u003C= 1 x ULN, or \\\u003C= 3 x ULN in patients with known or suspected Gilbert's Syndrome\n* Alanine aminotransferase (ALT) \\\u003C= 1.5 x ULN\n* Aspartate aminotransferase (AST) \\\u003C= 1.5 x ULN\n* Individuals serologically positive for human immunodeficiency virus (HIV) must:\n\n  * be on effective anti-retroviral therapy for at least 4 weeks; and\n  * have undetectable viral load; and\n  * have the CD4 count \\>=200 cells\u002FmicroL; and\n  * have no reported opportunistic infections or Castleman s disease within 12 months prior to study treatment initiation\n* Individuals serologically positive for Hepatitis C virus (HCV) or Hepatitis B virus (HCB) must have an undetectable viral load.\n* Individuals of child-bearing potential (IOCBP) must agree to use a highly effective method of contraception (hormonal, intrauterine device (IUD), surgical sterilization, abstinence) for the duration of the study treatment and up to 2 months after the last dose of PRGN-2009 and an effective method of contraception (barrier, hormonal, intrauterine device (IUD), surgical sterilization, abstinence) for 14 months after the last dose of cisplatin\u002Fdocetaxel. Note: IOCBP is defined as any woman who has experienced menarche and has not had a hysterectomy or bilateral oophorectomy or is not postmenopausal (amenorrheic 12 months or more following cessation of exogenous hormonal treatments; if \\\u003C50 years old and need follicle stimulating hormone \\[FSH\\] in the post-menopausal range).\n\nMen must agree to use a highly effective method of contraception (surgical sterilization, abstinence) for the duration of the study treatment and up to 2 months after the last dose of PRGN-2009 and an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to 11 months after the last dose of the study drug(s). We also will recommend men on treatment with PRGN-2009 with female partners of childbearing potential ask female partners to be on highly effective birth control (hormonal, intrauterine device (IUD), surgical sterilization) during PRGN-2009 treatment and 2 months after that.\n\n* Breastfeeding individuals must be willing to discontinue breastfeeding from study treatment initiation through 2 months after the last dose of the study drug(s).\n* Individuals must have a tumor site that is amenable to biopsy and be willing to undergo pre- treatment biopsy for research purposes.\n* Individuals must be willing to undergo pre-treatment PET\u002FCT imaging study.\n* The ability of an individual to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Peripheral motor or sensory neuropathy \\> Grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) v.5 at screening.\n* Prior therapy with an investigational drug, live vaccine, chemotherapy, immunotherapy, or any prior radiotherapy (except for palliative bone-directed therapy) within 4 weeks prior to the first study drug administration. Note: Participants may continue adjuvant hormonal therapy in the setting of a definitively treated cancer (e.g., breast).\n* Prior therapy with any medications or substances that are moderate or strong inducers or moderate or strong inhibitors of cytochrome P450 (CYP3A) https:\u002F\u002Fwww.fda.gov\u002FDrugs\u002FDevelopmentApprovalProcess\u002FDevelopmentResources\u002FDrugInteractionsLabeling\u002Fucm093664.htm#table2-2,table3-3,table5-2 within 2 weeks prior to the first study drug administration.\n* History of allergic reactions attributed to compounds of similar chemical or biological composition to drugs used in the study.\n* Systemic (intravenous or oral) glucocorticoid (except for physiologic doses of corticosteroids, i.e., \\\u003C= the equivalent of prednisone 10 mg\u002Fday) or other immunosuppressors such as azathioprine or cyclosporin A within 1 week prior to study treatment initiation. Note: Glucocorticoids as premedication for contrast-enhanced studies are allowed.\n* Second malignancy active within the previous 2 years except for indolent or locally curable malignancy that is currently considered cured and\u002For does not require an additional standard of care treatment, such as, but not limited to, cutaneous basal or squamous cell carcinoma, superficial bladder cancer, or cervical carcinoma in situ, or an incidental histological finding of prostate cancer or differentiated thyroid cancer.\n* Prior allogenic tissue\u002Fsolid organ transplant.\n* History of heart failure.\n* Positive beta-human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test performed in females of childbearing potential at screening.\n* Uncontrolled intercurrent illness or medical condition(s) evaluated by medical history and physical exam or situations that are not stable (e.g., recent hospitalization, Emergency Room visit or undergoing medication changes) that would potentially increase risk for the participant.","ALL","18 Years","120 Years",{"count":19,"type":20},70,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Background:\n\nThroat cancer is a common tumor that can occur in people infected with the human papilloma virus (HPV). Most people with this cancer survive more than 5 years with standard chemotherapy drugs plus radiation. But radiation can cause serious adverse effects. Researchers believe that adding a vaccine (PRGN-2009) to this drug therapy may improve survival without the need for radiation.\n\nObjective:\n\nTo test a study vaccine combined with standard chemotherapy in patients with HPV-associated throat cancers.\n\nEligibility:\n\nPeople aged 18 years and older with newly diagnosed throat cancer associated with HPV.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam and blood tests. They will have imaging scans and tests of their heart function and hearing. They will provide a sample of tissue from their tumor. A recent sample may be used; if none is available, a new sample will be taken.\n\nAll participants will get two common drugs for treating cancer. These drugs are given through a tube attached to a needle inserted into a vein in the arm. Participants will receive these drugs on the first day of three 3-week cycles.\n\nHalf of the participants will also get the vaccine. PRGN-2009 is injected under the skin in the arm. They will get these shots 4 times: 7 days before the start of the first cycle and on the 11th day of each cycle.\n\nParticipants will have standard surgery to remove their tumors 3 to 6 weeks after completing the study treatment. They will have follow-up visits 3, 6, 12, and 24 months after their surgery.\n\n...",[26,27,28,29,30],"Squamous Cell Carcinoma of the Head and Neck","Oropharynx","Human Papillomavirus Viruses","Drug Therapy","Cancer Vaccine",[32,33,34,35],"Neoadjuvant Chemotherapy","Oropharynx Cancer","Human Papillomavirus","Therapeutic Vaccine","RECRUITING","2026-06-09",{"date":39,"type":40},"2026-06-10","ACTUAL",{"date":42,"type":40},"2024-06-10",{"date":44,"type":20},"2028-01-10",{"name":46,"class":47},"National Cancer Institute (NCI)","NIH",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":21,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":48},"100563023","phase-1-huc-msc-for-treatment-of-high-risk-hpv-infection-100563023","NCT06610773","HUC-MSC for Treatment of High-risk HPV Infection","Effectiveness and Safety of Human Umbilical Cord Mesenchymal Stem Cells for the Treatment of HPV High-risk Infection","Inclusion Criteria:\n\n1. Women aged 25-60 with a sexual history of more than 2 years;\n2. Confirmed HPV infection by HPV-24 test;Patients diagnosed with high-risk human papillomavirus (HR-HPV) persistent infection; (note: the HR HPV: HPV 16\u002F18\u002F31\u002F33\u002F35\u002F39\u002F45\u002F51\u002F52\u002F53\u002F56\u002F58\u002F59\u002F66\u002F68; 15 types)\n3. The subjects were not participating in other clinical trials at the same time, and had no other anti-HPV drugs or intervention therapy recently;\n4. If the pregnancy test is negative and the subjects have fertility potential, they agree to use effective contraception during the study period and within 6 months of completion or termination of the study;\n5. Voluntarily participate in and agree to cooperate in accordance with the requirements of the program, and sign the informed consent.\n\nExclusion Criteria:\n\n1. Women who are preparing for pregnancy, pregnancy or breastfeeding;\n2. Pathological diagnosis of high-grade squamous intraepithelial lesion (HSIL) or cervical cancer;\n3. Previous HPV vaccinations;\n4. A history of severe drug allergies, or allergies to stem cell products or other biologics;\n5. Previous cervical site physical therapy or related surgical history;\n6. Patients with severe immune dysfunction (such as AIDS, systemic lupus erythematosus and other immune system diseases or history of organ transplantation, malignant tumor chemotherapy history), serious cardiovascular, liver, kidney, nervous, hematopoietic system diseases or malignant tumors, or mental diseases;\n7. Recent use of other antiviral drugs, immunosuppressants, immunomodulators or steroid hormones that affect the immune system;\n8. Patients with acute genital tract inflammation or pelvic inflammation;\n9. Those who have participated in or are participating in clinical trials of other drugs within three months;\n10. Other conditions considered inappropriate by the investigator for inclusion in this clinical trial.","FEMALE","25 Years","60 Years",{"count":60,"type":20},60,[62,23],"PHASE1","To evaluate the safety and initial effectiveness of human umbilical cord mesenchymal stem cells in HPV clearance.",[28,65],"Mesenchymal Stem Cells",[67,68],"HPV","hUC-MSC","2024-09-22",{"date":71,"type":40},"2024-09-24",{"date":73,"type":40},"2024-03-01",{"date":75,"type":20},"2026-09-10",{"name":77,"class":78},"Shanghai East Hospital","OTHER"]