[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100460887":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":42,"centralContacts":35,"locations":47,"responsibleParty":607,"collaborators":609,"id":613,"slug":614,"hasResults":615,"nctId":616,"briefTitle":617,"officialTitle":618,"acronym":35,"eligibilityCriteria":619,"healthyVolunteers":615,"sex":620,"minAge":621,"maxAge":35,"enrollmentInfo":622,"targetDuration":35,"studyType":625,"phases":626,"briefSummary":628,"conditions":629,"keywords":637,"overallStatus":50,"whyStopped":35,"lastUpdateSubmitDate":659,"lastUpdatePostDateStruct":660,"startDateStruct":663,"completionDateStruct":665,"leadSponsor":667,"locationsCount":668},{"fullName":5,"class":6},"Genelux Corporation","INDUSTRY",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Olvi-Vec + Platinum-doublet & bevacizumab","EXPERIMENTAL","Olvi-Vec: A total of 2 consecutive days of intraperitoneal catheter infusions in Week 0\n\nPlatinum-doublet \\& bevacizumab (or biosimilar) administered beginning in Week 4 (preferred), but no later than Week 5",[13,14,15,16],"Biological: olvimulogene nanivacirepvec","Drug: Platinum chemotherapy: carboplatin (preferred) or cisplatin","Drug: Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicin","Drug: Bevacizumab (or biosimilar)",{"label":18,"type":19,"description":20,"interventionNames":21},"Physician's Choice of Chemotherapy & bevacizumab","ACTIVE_COMPARATOR","Physician's Choice of chemotherapy \\& bevacizumab (or biosimilar) administered beginning in Week 0. Physician's Choice of chemotherapy includes either a single agent non-platinum chemotherapy, or as platinum chemotherapy is allowed as an option, a platinum-doublet (i.e., platinum agent combined with a non-platinum agent).",[14,15,16],[23,30,36,39],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"BIOLOGICAL","olvimulogene nanivacirepvec","Olvi-Vec is an engineered oncolytic vaccinia virus",[9],[29],"GL-ONC1 and GLV-1h68",{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Platinum chemotherapy: carboplatin (preferred) or cisplatin","Administered according to local practice",[9,18],null,{"type":31,"name":37,"description":33,"armGroupLabels":38,"otherNames":35},"Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicin",[9,18],{"type":31,"name":40,"description":33,"armGroupLabels":41,"otherNames":35},"Bevacizumab (or biosimilar)",[9,18],[43],{"name":44,"affiliation":45,"role":46},"Robert W. Holloway, MD","AdventHealth Cancer Institute","PRINCIPAL_INVESTIGATOR",[48,70,91,107,126,142,157,173,188,205,222,239,258,279,295,312,325,345,360,381,398,413,430,446,462,482,504,524,541,562,578,590],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"The University of South Alabama, Mitchell Cancer Institute","RECRUITING","Mobile","Alabama","36604","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-88.04305,30.69436,{"lat":60,"lon":59},[63,68],{"name":64,"role":65,"phone":66,"phoneExt":35,"email":67},"Stefanie White","CONTACT","251-445-9834","swhite@southalabama.edu",{"name":69,"role":46,"phone":35,"phoneExt":35,"email":35},"Jennifer Pierce, MD",{"facility":71,"status":50,"city":72,"state":73,"zip":74,"country":54,"countryCode":55,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"University of Arizona Cancer Center","Tucson","Arizona","85719",{"type":57,"coordinates":76},[77,78],-110.92648,32.22174,{"lat":78,"lon":77},[81,85,89],{"name":82,"role":65,"phone":83,"phoneExt":35,"email":84},"Mitzi Miranda","520-626-0905","MMiranda@uacc.arizona.edu",{"name":86,"role":65,"phone":87,"phoneExt":35,"email":88},"Brianna Loughran","520-626-0939","bloughran@arizona.edu",{"name":90,"role":46,"phone":35,"phoneExt":35,"email":35},"Setsuko K. Chambers, MD",{"facility":92,"status":50,"city":93,"state":94,"zip":95,"country":54,"countryCode":55,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"City of Hope","Duarte","California","91010",{"type":57,"coordinates":97},[98,99],-117.97729,34.13945,{"lat":99,"lon":98},[102,106],{"name":103,"role":65,"phone":104,"phoneExt":35,"email":105},"Edward Wang, MD, PhD","877-467-3411","edwang@coh.org",{"name":103,"role":46,"phone":35,"phoneExt":35,"email":35},{"facility":108,"status":50,"city":109,"state":94,"zip":110,"country":54,"countryCode":55,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"UC San Diego Health - Moores Cancer Center","La Jolla","92093",{"type":57,"coordinates":112},[113,114],-117.2742,32.84727,{"lat":114,"lon":113},[117,121,123],{"name":118,"role":65,"phone":119,"phoneExt":35,"email":120},"Erika Peterson","858-822-5352","espeterson@health.ucsd.edu",{"name":122,"role":46,"phone":35,"phoneExt":35,"email":35},"Michael McHale, MD",{"name":124,"role":125,"phone":35,"phoneExt":35,"email":35},"Ramez Eskander, MD","SUB_INVESTIGATOR",{"facility":127,"status":50,"city":128,"state":94,"zip":129,"country":54,"countryCode":55,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Hoag Gynecologic Oncology","Newport Beach","92663",{"type":57,"coordinates":131},[132,133],-117.92895,33.61891,{"lat":133,"lon":132},[136,140],{"name":137,"role":65,"phone":138,"phoneExt":35,"email":139},"Esmeralda Martinez","949-764-5827","Esmeralda.Martinez@hoag.org",{"name":141,"role":46,"phone":35,"phoneExt":35,"email":35},"Alberto Mendivil, MD",{"facility":143,"status":50,"city":144,"state":94,"zip":145,"country":54,"countryCode":55,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"UCI Health Chao Family Comprehensive Cancer Center","Orange","92868",{"type":57,"coordinates":147},[148,149],-117.85311,33.78779,{"lat":149,"lon":148},[152,156],{"name":153,"role":65,"phone":154,"phoneExt":35,"email":155},"Krishnansu S. Tewari, MD","714-456-7971","ktewari@hs.uci.edu",{"name":153,"role":46,"phone":35,"phoneExt":35,"email":35},{"facility":45,"status":50,"city":158,"state":159,"zip":160,"country":54,"countryCode":55,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Orlando","Florida","32804",{"type":57,"coordinates":162},[163,164],-81.37924,28.53834,{"lat":164,"lon":163},[167,171],{"name":168,"role":65,"phone":169,"phoneExt":35,"email":170},"Karla Hernandez-Cruz","407-609-3462","orl.gynoncologyresearch@AdventHealth.com",{"name":172,"role":46,"phone":35,"phoneExt":35,"email":35},"Robert W Holloway, MD",{"facility":174,"status":50,"city":175,"state":159,"zip":176,"country":54,"countryCode":55,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"Sarasota Memorial Healthcare System","Sarasota","34239",{"type":57,"coordinates":178},[179,180],-82.53065,27.33643,{"lat":180,"lon":179},[183,186],{"name":174,"role":65,"phone":184,"phoneExt":35,"email":185},"941-917-2225","ResearchInstitute@smh.com",{"name":187,"role":46,"phone":35,"phoneExt":35,"email":35},"Beverly Long, MD",{"facility":189,"status":50,"city":190,"state":159,"zip":191,"country":54,"countryCode":55,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"Women's Cancer Associates with Women's Care Florida","St. Petersburg","33713",{"type":57,"coordinates":193},[194,195],-82.67927,27.77086,{"lat":195,"lon":194},[198,203],{"name":199,"role":65,"phone":200,"phoneExt":201,"email":202},"Rebekah Little","727-826-0795","6","rebekah.little@baycare.org",{"name":204,"role":46,"phone":35,"phoneExt":35,"email":35},"Megan Indermaur, MD",{"facility":206,"status":50,"city":207,"state":208,"zip":209,"country":54,"countryCode":55,"cosmosGeoPoint":210,"geoPoint":214,"contacts":215},"Emory University","Atlanta","Georgia","30322",{"type":57,"coordinates":211},[212,213],-84.38798,33.749,{"lat":213,"lon":212},[216,220],{"name":217,"role":65,"phone":218,"phoneExt":35,"email":219},"Winship Referrals","404-778-1900","winship.referrals@emoryhealthcare.org",{"name":221,"role":46,"phone":35,"phoneExt":35,"email":35},"Jennifer Scalici, MD",{"facility":223,"status":50,"city":224,"state":225,"zip":226,"country":54,"countryCode":55,"cosmosGeoPoint":227,"geoPoint":231,"contacts":232},"Indiana University Simon Comprehensive Cancer Center","Indianapolis","Indiana","46202",{"type":57,"coordinates":228},[229,230],-86.15804,39.76838,{"lat":230,"lon":229},[233,237],{"name":234,"role":65,"phone":235,"phoneExt":35,"email":236},"Cheri West, RN","317-278-3021","chawest@iu.edu",{"name":238,"role":46,"phone":35,"phoneExt":35,"email":35},"Jessica E. Parker, MD",{"facility":240,"status":50,"city":241,"state":242,"zip":243,"country":54,"countryCode":55,"cosmosGeoPoint":244,"geoPoint":248,"contacts":249},"Holy Cross Hospital","Silver Spring","Maryland","20910",{"type":57,"coordinates":245},[246,247],-77.02609,38.99067,{"lat":247,"lon":246},[250,254,256],{"name":251,"role":65,"phone":252,"phoneExt":35,"email":253},"Lyudmila Igorevna Kalnitskaya, MBA, MS","301-754-7552","kalnitsl@holycrosshealth.org",{"name":255,"role":46,"phone":35,"phoneExt":35,"email":35},"Frederick D Min, MD",{"name":257,"role":125,"phone":35,"phoneExt":35,"email":35},"Jasmine Ebott, MD",{"facility":259,"status":50,"city":260,"state":261,"zip":262,"country":54,"countryCode":55,"cosmosGeoPoint":263,"geoPoint":267,"contacts":268},"University of Michigan","Ann Arbor","Michigan","48109",{"type":57,"coordinates":264},[265,266],-83.74088,42.27756,{"lat":266,"lon":265},[269,273,277],{"name":270,"role":65,"phone":271,"phoneExt":35,"email":272},"Zhen Zhou","917-912-3028","zhenniz@med.umich.edu",{"name":274,"role":65,"phone":275,"phoneExt":35,"email":276},"Munira Hussain","734-936-8349","hussain@med.umich.edu",{"name":278,"role":46,"phone":35,"phoneExt":35,"email":35},"Jean Siedel, MD",{"facility":280,"status":50,"city":281,"state":261,"zip":282,"country":54,"countryCode":55,"cosmosGeoPoint":283,"geoPoint":287,"contacts":288},"Karmanos Cancer Institute","Detroit","48201",{"type":57,"coordinates":284},[285,286],-83.04575,42.33143,{"lat":286,"lon":285},[289,293],{"name":290,"role":65,"phone":291,"phoneExt":35,"email":292},"Elizabeth Linnik","313-576-9764","linnike@karmanos.org",{"name":294,"role":46,"phone":35,"phoneExt":35,"email":35},"Robert Morris, MD",{"facility":296,"status":50,"city":297,"state":298,"zip":299,"country":54,"countryCode":55,"cosmosGeoPoint":300,"geoPoint":304,"contacts":305},"Washington University School of Medicine","St Louis","Missouri","63110",{"type":57,"coordinates":301},[302,303],-90.19789,38.62727,{"lat":303,"lon":302},[306,310],{"name":307,"role":65,"phone":308,"phoneExt":35,"email":309},"Tiara Redrick","314-362-1705","tredrick@wustl.edu",{"name":311,"role":46,"phone":35,"phoneExt":35,"email":35},"Premal Thaker, MD",{"facility":313,"status":50,"city":297,"state":298,"zip":314,"country":54,"countryCode":55,"cosmosGeoPoint":315,"geoPoint":317,"contacts":318},"Mercy Hospital St. Louis","63141",{"type":57,"coordinates":316},[302,303],{"lat":303,"lon":302},[319,323],{"name":320,"role":65,"phone":321,"phoneExt":35,"email":322},"Enguday Teshome","314-251-0742","Enguday.teshome@mercy.net",{"name":324,"role":46,"phone":35,"phoneExt":35,"email":35},"Madhavi Manyam, MD",{"facility":326,"status":50,"city":327,"state":328,"zip":329,"country":54,"countryCode":55,"cosmosGeoPoint":330,"geoPoint":334,"contacts":335},"Women's Cancer Center of Nevada","Las Vegas","Nevada","89106",{"type":57,"coordinates":331},[332,333],-115.13722,36.17497,{"lat":333,"lon":332},[336,340,343],{"name":337,"role":65,"phone":338,"phoneExt":35,"email":339},"Thania Escamilla","702-851-4672","tescamilla@wccenter.com",{"name":341,"role":65,"phone":338,"phoneExt":35,"email":342},"Jacky Amador","Jamador@wccenter.com",{"name":344,"role":46,"phone":35,"phoneExt":35,"email":35},"Nicola M. Spirtos, MD",{"facility":346,"status":50,"city":347,"state":328,"zip":348,"country":54,"countryCode":55,"cosmosGeoPoint":349,"geoPoint":353,"contacts":354},"Center of Hope","Reno","89511",{"type":57,"coordinates":350},[351,352],-119.8138,39.52963,{"lat":352,"lon":351},[355,359],{"name":356,"role":65,"phone":357,"phoneExt":35,"email":358},"Peter Lim, MD","775-327-4611","Plim@cohreno.com",{"name":356,"role":46,"phone":35,"phoneExt":35,"email":35},{"facility":361,"status":50,"city":362,"state":363,"zip":364,"country":54,"countryCode":55,"cosmosGeoPoint":365,"geoPoint":369,"contacts":370},"Stony Brook Cancer Center","Stony Brook","New York","11794",{"type":57,"coordinates":366},[367,368],-73.14094,40.92565,{"lat":368,"lon":367},[371,375,379],{"name":372,"role":65,"phone":373,"phoneExt":35,"email":374},"Latrice Tribble-Jones","631-620-1814","latrice.tribble@stonybrookmedicine.edu",{"name":376,"role":65,"phone":377,"phoneExt":35,"email":378},"Xavier Geoffroy, MSN, RN","631-649-5701","xavier.geoffroy@stonybrookmedicine.edu",{"name":380,"role":46,"phone":35,"phoneExt":35,"email":35},"Gabrielle Gossner, MD",{"facility":382,"status":50,"city":383,"state":384,"zip":385,"country":54,"countryCode":55,"cosmosGeoPoint":386,"geoPoint":390,"contacts":391},"Levine Cancer Institute","Charlotte","North Carolina","28204",{"type":57,"coordinates":387},[388,389],-80.84313,35.22709,{"lat":389,"lon":388},[392,396],{"name":393,"role":65,"phone":394,"phoneExt":35,"email":395},"Leah Wilson","980-442-2333","Leah.J.Wilson@atriumhealth.org",{"name":397,"role":46,"phone":35,"phoneExt":35,"email":35},"Erin K Crane, MD",{"facility":399,"status":50,"city":400,"state":384,"zip":401,"country":54,"countryCode":55,"cosmosGeoPoint":402,"geoPoint":406,"contacts":407},"East Carolina University","Greenville","27834",{"type":57,"coordinates":403},[404,405],-77.36635,35.61266,{"lat":405,"lon":404},[408,412],{"name":409,"role":65,"phone":410,"phoneExt":35,"email":411},"Grainger Lanneau, MD","252-816-2743","Grainger.Lanneau@ecuhealth.org",{"name":409,"role":46,"phone":35,"phoneExt":35,"email":35},{"facility":414,"status":50,"city":415,"state":416,"zip":417,"country":54,"countryCode":55,"cosmosGeoPoint":418,"geoPoint":422,"contacts":423},"Cleveland Clinic","Cleveland","Ohio","44195",{"type":57,"coordinates":419},[420,421],-81.69541,41.4995,{"lat":421,"lon":420},[424,428],{"name":425,"role":65,"phone":426,"phoneExt":35,"email":427},"Barbara Bittel","216-390-2456","Bittelb@ccf.org",{"name":429,"role":46,"phone":35,"phoneExt":35,"email":35},"Peter Rose, MD",{"facility":431,"status":50,"city":432,"state":416,"zip":433,"country":54,"countryCode":55,"cosmosGeoPoint":434,"geoPoint":438,"contacts":439},"OhioHealth Research Institute","Columbus","43214",{"type":57,"coordinates":435},[436,437],-82.99879,39.96118,{"lat":437,"lon":436},[440,444],{"name":441,"role":65,"phone":442,"phoneExt":35,"email":443},"Jennifer Sexton","614-788-3860","Jennifer.Sexton@ohiohealth.com",{"name":445,"role":46,"phone":35,"phoneExt":35,"email":35},"Aine Clements, MD",{"facility":447,"status":50,"city":448,"state":416,"zip":449,"country":54,"countryCode":55,"cosmosGeoPoint":450,"geoPoint":454,"contacts":455},"Kettering Health","Kettering","45429",{"type":57,"coordinates":451},[452,453],-84.16883,39.6895,{"lat":453,"lon":452},[456,460],{"name":457,"role":65,"phone":458,"phoneExt":35,"email":459},"Daniel Geyer","937-395-6017","daniel.geyer@ketteringhealth.org",{"name":461,"role":46,"phone":35,"phoneExt":35,"email":35},"Thomas J. Reid, MD",{"facility":463,"status":50,"city":464,"state":416,"zip":465,"country":54,"countryCode":55,"cosmosGeoPoint":466,"geoPoint":470,"contacts":471},"ProMedica Flower Hospital","Sylvania","43560",{"type":57,"coordinates":467},[468,469],-83.71299,41.71894,{"lat":469,"lon":468},[472,476,480],{"name":473,"role":65,"phone":474,"phoneExt":35,"email":475},"Carissa Jock","419-824-1011","Carissa.jock@promedica.org",{"name":477,"role":65,"phone":478,"phoneExt":35,"email":479},"Julie Moon","419-824-8812","Julie.moon@promedica.org",{"name":481,"role":46,"phone":35,"phoneExt":35,"email":35},"Adam Walter, MD",{"facility":483,"status":50,"city":484,"state":485,"zip":486,"country":54,"countryCode":55,"cosmosGeoPoint":487,"geoPoint":491,"contacts":492},"Oklahoma University Health Stephenson Cancer Center","Oklahoma City","Oklahoma","73104",{"type":57,"coordinates":488},[489,490],-97.51643,35.46756,{"lat":490,"lon":489},[493,498,503],{"name":494,"role":65,"phone":495,"phoneExt":496,"email":497},"Nikolas Williams","405-271-8001","18001","nikolas-williams@ou.edu",{"name":499,"role":65,"phone":500,"phoneExt":501,"email":502},"Debra Richardson, MD","405-271-1112","31839","debra-richardson@ou.edu",{"name":499,"role":46,"phone":35,"phoneExt":35,"email":35},{"facility":505,"status":50,"city":506,"state":507,"zip":508,"country":54,"countryCode":55,"cosmosGeoPoint":509,"geoPoint":513,"contacts":514},"AHN West Penn Hospital","Pittsburgh","Pennsylvania","15224",{"type":57,"coordinates":510},[511,512],-79.99589,40.44062,{"lat":512,"lon":511},[515,519,523],{"name":516,"role":65,"phone":517,"phoneExt":35,"email":518},"Sarah Crafton, MD","412-578-1116","Sarah.Crafton@ahn.org",{"name":520,"role":65,"phone":521,"phoneExt":35,"email":522},"AHN Clinical Trial","412-359-3731","clinicaltrials@ahn.org",{"name":516,"role":46,"phone":35,"phoneExt":35,"email":35},{"facility":525,"status":50,"city":526,"state":527,"zip":528,"country":54,"countryCode":55,"cosmosGeoPoint":529,"geoPoint":533,"contacts":534},"Hollings Cancer Center","Charleston","South Carolina","29425",{"type":57,"coordinates":530},[531,532],-79.93275,32.77632,{"lat":532,"lon":531},[535,539],{"name":536,"role":65,"phone":537,"phoneExt":35,"email":538},"Crystal Knox","843-792-2803","knoxc@musc.edu",{"name":540,"role":46,"phone":35,"phoneExt":35,"email":35},"Brian Orr, MD",{"facility":542,"status":50,"city":543,"state":544,"zip":545,"country":54,"countryCode":55,"cosmosGeoPoint":546,"geoPoint":550,"contacts":551},"Erlanger Health, Inc.","Chattanooga","Tennessee","37403",{"type":57,"coordinates":547},[548,549],-85.30968,35.04563,{"lat":549,"lon":548},[552,556,560],{"name":553,"role":65,"phone":554,"phoneExt":35,"email":555},"Lorraine Christensen","423-778-3902","Lorraine.Christensen@erlanger.org",{"name":557,"role":65,"phone":558,"phoneExt":35,"email":559},"Kimberly Donelson","423-778-3916","Kimberly.Donelson@erlanger.org",{"name":561,"role":46,"phone":35,"phoneExt":35,"email":35},"Stephen DePasquale, MD",{"facility":563,"status":50,"city":564,"state":565,"zip":566,"country":54,"countryCode":55,"cosmosGeoPoint":567,"geoPoint":571,"contacts":572},"Baylor College of Medicine","Houston","Texas","77030",{"type":57,"coordinates":568},[569,570],-95.36327,29.76328,{"lat":570,"lon":569},[573,577],{"name":574,"role":65,"phone":575,"phoneExt":35,"email":576},"Jan Sunde, MD","832-957-6500","jan.sunde@bcm.edu",{"name":574,"role":46,"phone":35,"phoneExt":35,"email":35},{"facility":579,"status":50,"city":564,"state":565,"zip":566,"country":54,"countryCode":55,"cosmosGeoPoint":580,"geoPoint":582,"contacts":583},"University of Texas Science Center at Houston, McGovern Medical School",{"type":57,"coordinates":581},[569,570],{"lat":570,"lon":569},[584,588],{"name":585,"role":65,"phone":586,"phoneExt":35,"email":587},"Gabrielle Hayes","713-704-4137","gabrielle.a.hayes@uth.tmc.edu",{"name":589,"role":46,"phone":35,"phoneExt":35,"email":35},"Joseph Lucci, III, MD",{"facility":591,"status":50,"city":592,"state":593,"zip":594,"country":54,"countryCode":55,"cosmosGeoPoint":595,"geoPoint":599,"contacts":600},"Providence Sacred Heart Medical Center & Children's Hospital","Spokane","Washington","99204",{"type":57,"coordinates":596},[597,598],-117.42908,47.65966,{"lat":598,"lon":597},[601,605],{"name":602,"role":65,"phone":603,"phoneExt":35,"email":604},"Jodie Mactagone, CRC","509-474-3821","Jodie.mactagone@providence.org",{"name":606,"role":46,"phone":35,"phoneExt":35,"email":35},"Melanie Bergman, MD",{"type":608,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR",[610],{"name":611,"class":612},"GOG Foundation","NETWORK","100460887","phase-3-efficacy--safety-of-olvi-vec-and-platinum-doublet--bevacizumab-compared-to-physicians-choice-of-chemotherapy-and-bevacizumab-in-platinum-resistantrefractory-ovarian-cancer-prroc-onprime-gog-3076-100460887",false,"NCT05281471","Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant\u002FRefractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)","A Randomized Phase 3 Study Assessing the Efficacy and Safety of Olvi-Vec Followed by Platinum-doublet Chemotherapy and Bevacizumab Compared With Physician's Choice of Chemotherapy and Bevacizumab in Women With Platinum-Resistant\u002FRefractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)","Inclusion Criteria:\n\n* Histologically confirmed (from prior treatment) non-resectable ovarian, fallopian tube or primary peritoneal cancer.\n* High-grade serous \\[including malignant mixed Mullerian tumor (MMMT) with metastasis that contains high-grade epithelial carcinoma, FIGO grades 2 \\& 3 allowed\\], endometrioid, or clear-cell ovarian cancer.\n* Performance status ECOG of 0 or 1.\n* Life expectancy of at least 6 months.\n* Received a minimum of 3 prior lines (including the 1st line) of systemic therapy with no maximal limit.\n* Platinum-resistant or -refractory disease based on platinum-free interval (PFI) from the last dose of the most recent. platinum-based line of therapy (must have received a minimum of 2 doses of platinum in that line) to subsequent disease progression based on radiological assessment. Platinum-refractory: PFI of \\\u003C 1 month (including disease progression while on platinum-based therapy). Platinum-resistant: PFI of 1-6 months.\n* Received prior bevacizumab (or biosimilar) treatment.\n* No contraindication to receive carboplatin, cisplatin or bevacizumab (or biosimilar).\n* Have disease progression after last prior line of therapy based on radiological assessment prior to randomization.\n* At least 1 measurable target lesion per RECIST 1.1 based on abdominal\u002Fpelvis imaging scan at screening.\n* Evidence by CT and\u002For PET scans or physical exam of abdominal\u002Fpelvis region likely having disease in the peritoneal cavity (i.e., peritoneal carcinomatosis).\n* Adequate renal, hepatic, bone marrow function, adequate coagulation tests, adequate immune function by lymphocyte count.\n\nExclusion Criteria:\n\n* Tumors of mucinous, low-grade serous, squamous cell, small cell neuroendocrine subtypes, MMMT tumors absent an epithelial component on recent biopsy, or non-epithelial ovarian cancers (e.g., germ cell tumors, Sex-cord tumors).\n* Bowel obstruction within last 3 months prior to screening.\n* Active urinary tract infection, pneumonia, other systemic infections.\n* Active gastrointestinal bleeding.\n* Known current central nervous system (CNS) metastasis.\n* Inflammatory diseases of the bowel.\n* History of HIV infection.\n* Active hepatitis B virus or hepatitis C virus within 4 weeks prior to study.\n* History of thromboembolic event within the prior 3 months.\n* Contraindications for intraperitoneal (IP) catheter placement: Bowel obstruction with distended abdomen, rigid abdomen with bulky anterior wall carcinomatosis, abdominal wall hernia mesh that precludes laparoscopic entry to abdomen.\n* Clinically significant cardiac disease at screening (New York Heart Association Class III\u002FIV).\n* Acute cerebrovascular event(s) such as cerebrovascular accident (CVA) or transient ischemic attack (TIA) in previous 6 months.\n* Oxygen saturation \\\u003C90%.\n* Received prior virus-based gene therapy or therapy with cytolytic virus of any type.\n* Receiving concurrent antiviral agent.\n* Prior malignancy of other histology active within previous 3 years except for locally curable cancers apparently cured such as basal\u002Fsquamous cell skin cancer, superficial bladder cancer, carcinoma in situ of cervix or breast, any other stage I\u002FII local malignancies.\n* Received chemotherapy, radiotherapy, other anti-cancer biologic therapies within 4 weeks prior to planned treatment.\n* Underwent surgery within 4 weeks, or have insufficient recovery from surgical-related trauma or wound healing, prior to first study treatment in either Arm.\n* Receiving immunosuppressive therapy or steroids (except acute concurrent corticosteroid of no more than 20 mg per day for medical management with prednisolone equivalent.\n* Symptomatic malignant ascites or pleural effusions defined as rapidly progressive ascites with abdominal distension and gastrointestinal dysfunction, pleural effusions with respiratory difficulties requiring frequent paracentesis \\> once every 14 days.\n* Known hypersensitivity to gentamicin.","FEMALE","18 Years",{"count":623,"type":624},186,"ESTIMATED","INTERVENTIONAL",[627],"PHASE3","The OnPrime study is a multi-center, randomized open-label phase 3 study evaluating the safety and efficacy of Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab compared to the Active Comparator Arm with Physician's Choice of chemotherapy and bevacizumab in women diagnosed with platinum-resistant\u002Frefractory ovarian cancer (includes fallopian tube cancer and primary peritoneal cancer). This Phase III trial builds on the efficacy and safety data reported in the previous Phase II VIRO-15 trial with promising objective response rate and progression-free survival observed in heavily pre-treated patients with platinum-resistant\u002Frefractory ovarian cancer. The phase II results also showed that the intra-peritoneal route of delivery was efficient in generating tumor cell killing and immune activation, and led to clinical reversal of platinum-resistance or refractoriness in this difficult-to-treat patient population.",[630,631,632,633,634,635,636],"Platinum-resistant Ovarian Cancer","Platinum-refractory Ovarian Cancer","Fallopian Tube Cancer","Primary Peritoneal Cancer","High-grade Serous Ovarian Cancer","Endometrioid Ovarian Cancer","Ovarian Clear Cell Carcinoma",[25,638,639,640,641,642,643,644,645,646,647,648,649,650,651,652,653,654,655,656,657,658],"GL-ONC1","GLV-1h68","oncolytic virus","virotherapy","viral therapy","immunotherapy","immunochemotherapy","combination therapy","vaccinia virus","ovarian cancer","fallopian tube cancer","primary peritoneal cancer","platinum resistant","platinum refractory","recurrent ovarian cancer","platinum resensitization","chemoresistance","heavily pre-treated","immune activation","reversal of platinum resistance or refractoriness","resensitize","2026-07-08",{"date":661,"type":662},"2026-07-10","ACTUAL",{"date":664,"type":662},"2022-08-31",{"date":666,"type":624},"2027-12",{"name":5,"class":6},32]