[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intermediate-risk-non-muscle-invasive-bladder-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intermediate-risk-non-muscle-invasive-bladder-cancer":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100555306",false,"NCT06510374","Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer","A Phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer","ABLE-32","Inclusion Criteria:\n\n* Diagnosed with intermediate risk non-muscle invasive bladder cancer (IR NMIBC) as defined by American Urological Association (AUA)\u002FSociety of Urologic Oncology \\[SUO\\] Guideline (2020)\n* Has undergone adequate transurethral resection of bladder tumor (TURBT; with or without peri-operative chemotherapy) within 60 days prior to randomization:\n\n  * Recurrence within 1 year, low-grade Ta\n  * Solitary low-grade Ta \\>3 cm\n  * Low-grade Ta, multifocal\n  * Solitary high-grade Ta, ≤3 cm\n  * Low-grade T1\n\n    * Patients with T1 disease should undergo resection at the base of the lesion and biopsies should contain muscle fibres.\n    * Restage TURBT may be done at the discretion of the investigator\n\nExclusion Criteria:\n\n* Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented at the screening visit\n\nHigh risk NMIBC defined as:\n\n* High-grade T1\n* Any recurrent, high-grade Ta\n* High-grade Ta \\>3 cm (or multifocal)\n* Any carcinoma in situ (CIS)\n* Any Bacillus Calmette-Guérin (BCG) failure in high-grade subject\n* Any variant histology\n* Any prostatic urethral involvement\n\nLow risk NMIBC defined as:\n\n* First occurrence of low-grade solitary Ta ≤3 cm\n* Recurrence of low-grade solitary Ta ≤3 cm \\>12 months from previous occurrence\n* Papillary urothelial neoplasm of low malignant potential","ALL","18 Years",{"count":19,"type":20},454,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)",[26],"Intermediate Risk Non-Muscle Invasive Bladder Cancer","RECRUITING","2026-06-29",{"date":30,"type":31},"2026-07-01","ACTUAL",{"date":33,"type":31},"2024-10-01",{"date":35,"type":20},"2031-06-30",{"name":37,"class":38},"Ferring Pharmaceuticals","INDUSTRY",102,""]