[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100528160":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":77,"collaborators":79,"id":83,"slug":19,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":19,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":19,"enrollmentInfo":91,"targetDuration":19,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":104,"overallStatus":29,"whyStopped":19,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Precigen, Inc","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"PRGN-2009 plus Pembrolizumab","EXPERIMENTAL","PRGN-2009 at a dose of 5 x 10\\^11 PU q3W for 3 administrations, then q6w, plus Pembrolizumab, 400mg q6w",[13],"Biological: PRGN-2009 plus Pembrolizumab",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","Subjects randomized will receive PRGN-2009 (5 x 10\\^11 PU, subcutaneous (SC) injection) every 3 weeks for three administrations, thereafter subjects will continue to receive PRGN-2009 administrations every 6 weeks. Pembrolizumab will be administered concurrently as intravenous (IV) infusion (400 mg) every 6 weeks.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Amy Lankford","CONTACT","3015569900","clinicaltrials@precigen.com",[27,48,62],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"University of Arkansas for Medical Sciences","RECRUITING","Little Rock","Arkansas","72205","United States",{"type":35,"coordinates":36},"Point",[37,38],-92.28959,34.74648,{"lat":38,"lon":37},[41,45],{"name":42,"role":23,"phone":43,"phoneExt":19,"email":44},"Nou Yang","501-320-7749","NYXiong@uams.edu",{"name":46,"role":47,"phone":19,"phoneExt":19,"email":19},"Michael Birrer, MD, PhD","PRINCIPAL_INVESTIGATOR",{"facility":49,"status":29,"city":50,"state":51,"zip":52,"country":33,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"National Institute of Health","Bethesda","Maryland","20892",{"type":35,"coordinates":54},[55,56],-77.10026,38.98067,{"lat":56,"lon":55},[59],{"name":60,"role":23,"phone":19,"phoneExt":19,"email":61},"Shannon Householder","shannon.householder@nih.gov",{"facility":63,"status":29,"city":64,"state":65,"zip":66,"country":33,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"University of Washington","Seattle","Washington","98109",{"type":35,"coordinates":68},[69,70],-122.33207,47.60621,{"lat":70,"lon":69},[73],{"name":74,"role":23,"phone":75,"phoneExt":19,"email":76},"John Liao, MD","866-932-8588","cvitrial@uw.edu",{"type":78,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[80],{"name":81,"class":82},"National Cancer Institute (NCI)","NIH","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":92,"type":93},24,"ESTIMATED","INTERVENTIONAL",[96],"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.",[99,100,101,102,103],"Cervical Cancer","HPV-Related Carcinoma","HPV-Related Malignancy","Recurrent Cervical Carcinoma","Metastatic Cervical Cancer",[105,99,106,107,108,109],"Human Papilloma Virus","Pembrolizumab","Therapeutic Vaccine","Cervix Cancer","Resistance to Checkpoint Inhibitors","2026-04-20",{"date":112,"type":113},"2026-04-23","ACTUAL",{"date":115,"type":113},"2025-11-11",{"date":117,"type":93},"2030-11-30",{"name":5,"class":6},3]