[{"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":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":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100555306","phase-3-trial-of-nadofaragene-firadenovec-vs-observation-in-participants-with-intermediate-risk-non-muscle-invasive-bladder-cancer-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":20,"type":21},454,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)",[27],"Intermediate Risk Non-Muscle Invasive Bladder Cancer","RECRUITING","2026-06-29",{"date":31,"type":32},"2026-07-01","ACTUAL",{"date":34,"type":32},"2024-10-01",{"date":36,"type":21},"2031-06-30",{"name":38,"class":39},"Ferring Pharmaceuticals","INDUSTRY",102]