[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Precigen, Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":80},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100528160","phase-2-prgn-2009-in-combination-with-pembrolizumab-in-patients-with-recurrent-or-metastatic-cervical-cancer-100528160",false,"NCT06157151","PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer","A Multicenter Phase 2 Study to Evaluate Efficacy and Safety of PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer.","Inclusion Criteria:\n\n* Age 18 years and older.\n* Recurrent or metastatic cervical cancer (histologically or cytologically confirmed)\n* Must have been treated with pembrolizumab, either as monotherapy or in combination, for atleast 6 weeks.\n* Subjects must have histologically or cytologically confirmed HPV positive disease\n* Measurable disease that can be accurately measured by RECIST v1.1 criteria\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life expectancy ≥ 12 weeks from the time of enrollment.\n* Must have adequate organ function\n* Negative serum pregnancy test. Women of child-bearing potential (WOCBP) must agree to use adequate contraception prior to study entry and for at least 6 months following completion of study treatment.\n* All patients must have the ability to understand and willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n* Prior chemotherapy, targeted therapy within 14 days; monoclonal antibody within 4 weeks; unresolved AEs.\n* Immunodeficiency, active autoimmune disease on immunosuppression, or immunosuppressive therapy within 7 days. HIV eligible with disease control.\n* Active hepatitis B (HBsAg+) or hepatitis C (HCV RT-PCR+) within 30 days of enrollment.\n* History of non-infectious pneumonitis or interstitial lung disease.\n* History of endocrine autoimmune disease (exceptions: treated Graves' disease; hypothyroidism on replacement).\n* Live vaccine within 30 days prior to first dose.\n* Patients with presence of other active malignancy within 1 year prior to study entry\n* Known Central Nervous System (CNS) disease\n* Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n* Known history of active tuberculosis (TB, Bacillus tuberculosis).\n* Pregnant and lactating women are excluded from this study.\n* Patients with a history of solid organ transplant.\n* Patients currently participating in a study of an investigational agent or have used an investigational device within 4 weeks prior to the first dose of study treatment.\n* Patients, who in the opinion of the investigator, may not be able to comply with the monitoring requirements of the study.","ALL","18 Years",{"count":19,"type":20},24,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This Phase 2 study will evaluate the efficacy and safety of PRGN-2009 in combination with pembrolizumab in patients with pembrolizumab-resistant recurrent or metastatic cervical cancer.",[26,27,28,29,30],"Cervical Cancer","HPV-Related Carcinoma","HPV-Related Malignancy","Recurrent Cervical Carcinoma","Metastatic Cervical Cancer",[32,26,33,34,35,36],"Human Papilloma Virus","Pembrolizumab","Therapeutic Vaccine","Cervix Cancer","Resistance to Checkpoint Inhibitors","RECRUITING","2026-04-20",{"date":40,"type":41},"2026-04-23","ACTUAL",{"date":43,"type":41},"2025-11-11",{"date":45,"type":20},"2030-11-30",{"name":47,"class":48},"Precigen, Inc","INDUSTRY",3,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":49},"100557466","phase-4-zopa-retreatment-and-vector-shedding-in-adults-with-rrp-100557466","NCT06538480","Zopa Retreatment and Vector Shedding in Adults With RRP","Open-Label Study of Zopapogene Imadenovec Retreatment and Vector Shedding Evaluation in Adult Patients With Recurrent Respiratory Papillomatosis","Key Inclusion Criteria:\n\n* Age 18 years and older.\n* Clinical diagnosis of recurrent respiratory papillomatosis with histological confirmation of papilloma.\n* Cohort 1: Treatment-naïve with respect to Zopa.\n* Cohort 2: Received a minimum of four administrations of Zopa at 5 × 10\\^11 PU per injection and require clinically indicated debulking procedures.\n* Presence of laryngotracheal papillomas accessible for endoscopic cleanout.\n* ECOG performance status 0 or 1.\n* Sexually active participants of reproductive potential must agree to use contraception during treatment and for 120 days for males and 6 months for females after last dose.\n* Ability to understand and sign informed consent.\n\nKey Exclusion Criteria:\n\n* Conditions or therapies that increase risk or interfere with participation per investigator judgment.\n* Systemic corticosteroids \\>10 mg prednisone equivalent or other immunosuppressive medications within 14 days prior to dosing.\n* Other systemic RRP treatments or investigational agents within 30 days.\n* History of heparin-induced thrombocytopenia or vaccine-induced thrombotic thrombocytopenia.\n* Active uncontrolled HIV, hepatitis B, or hepatitis C infection.\n* Pregnant or nursing women.\n* Known allergy to any study drug component.",{"count":58,"type":20},30,[60],"PHASE4","This open-label study evaluates safety, vector shedding, and retreatment efficacy of Zopapogene imadenovec (Zopa) in adults with recurrent respiratory papillomatosis (RRP). Two cohorts will be enrolled (n=30): Cohort 1 to assess the magnitude and duration of adenoviral vector shedding in urine, feces, skin, and nasal tissue; Cohort 2 to assess the complete response rate following retreatment.",[63,64,65],"Recurrent Respiratory Papillomatosis","Papillomavirus Infection","Papillomaviridae",[32,67,68,69,70,71],"laryngotracheal disease","papillomatous disease","Viral Shedding","Retreatment","Zopapogene imadenovec","2025-12-11",{"date":74,"type":41},"2025-12-15",{"date":76,"type":41},"2024-07-11",{"date":78,"type":20},"2028-12-02",{"name":47,"class":48},""]