[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"platinum-refractory-ovarian-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:platinum-refractory-ovarian-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":33,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":68},"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":19,"type":20},186,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28,29,30,31,32],"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",[34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55],"olvimulogene nanivacirepvec","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","RECRUITING","2026-03-16",{"date":59,"type":60},"2026-03-18","ACTUAL",{"date":62,"type":60},"2022-08-31",{"date":64,"type":20},"2026-10",{"name":66,"class":67},"Genelux Corporation","INDUSTRY",31]