{"preliminary_commentary":{"by_channel":{"x_thread":2,"bluesky_thread":2},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":false},"name":"NCT04172675","nct_id":"NCT04172675","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct04172675. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Participants with high-risk non-muscle-invasive bladder cancer (NMIBC) presenting as papillary tumor only (carcinoma in situ \\[CIS\\], absent), with disease recurrence after bacillus Calmette- Guerin (BCG) therapy will receive treatment with erdafitinib.","label":"Cohort 1: Erdafitinib","type":"EXPERIMENTAL"},{"description":"Participants with high-risk NMIBC presenting as papillary tumor only (CIS, absent), with disease recurrence after BCG therapy will receive the investigator's choice of either intravesical gemcitabine or intravesical mitomycin C (MMC) or hyperthermic MMC. Participants who are randomized to gemcitabine or MMC or hyperthermic MMC in Cohort 1 and demonstrate a recurrence via investigator disease assessment will have the opportunity to cross over to treatment with erdafitinib.","label":"Cohort 1: Investigators Choice","type":"ACTIVE_COMPARATOR"},{"description":"Participants with high-risk, BCG- unresponsive NMIBC presenting as CIS with or without concurrent papillary tumor will receive treatment with erdafitinib.","label":"Cohort 2","type":"EXPERIMENTAL"},{"description":"Marker lesion study in intermediate-risk NMIBC presenting as papillary disease only. All enrolled participants will receive treatment with erdafitinib.","label":"Cohort 3","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2025-02-27","type":"ACTUAL"},"conditions":["Urinary Bladder Neoplasms"],"enrollment":{"count":107,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Erdafitinib","otherNames":["JNJ-42756493"],"type":"DRUG"},{"name":"Investigator Choice (Gemcitabine)","otherNames":[],"type":"DRUG"},{"name":"Investigator Choice (Mitomycin C)","otherNames":[],"type":"DRUG"}],"last_update":"2026-02-24","lead_sponsor":"Janssen Research & Development, LLC","official_title":"A Randomized Phase 2 Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Subjects Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) and FGFR Mutations or Fusions","overall_status":"COMPLETED","phases":["PHASE2"],"primary_completion_date":{"date":"2024-07-12","type":"ACTUAL"},"primary_outcomes":[{"measure":"Cohort 1: Recurrence-Free Survival (RFS)","timeFrame":"From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months"}],"references":[{"citation":"Han MA, Maisch P, Jung JH, Hwang JE, Narayan V, Cleves A, Hwang EC, Dahm P. Intravesical gemcitabine for non-muscle invasive bladder cancer. Cochrane Database Syst Rev. 2021 Jun 14;6(6):CD009294. doi: 10.1002/14651858.CD009294.pub3.","pmid":"34125951","type":"DERIVED"}],"start_date":{"date":"2020-02-28","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)","url":"https://clinicaltrials.gov/study/NCT04172675"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct04172675"}