{"preliminary_commentary":{"by_channel":{"x_thread":107,"podcast":48,"youtube":36,"x_video":3},"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":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT03390504\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"name":"THOR","nct_id":"NCT03390504","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=thor-nct03390504. 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":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"THOR","arms":[{"description":"Participants will be screened based on Fibroblast Growth Factor Receptor Inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-programmed cell death protein PD-\\[L\\] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events \\[AEs\\]). Participants who enter in Long-term extension (LTE) phase will continue to receive the erdafitinib tablet as per investigator's decision.","label":"Cohort 1 (Arm 1A): Erdafitinib","type":"EXPERIMENTAL"},{"description":"Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-PD-\\[L\\] 1 agent) will receive vinflunine 320 milligram per meter square (mg/m\\^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m\\^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities. Participants who enter in LTE phase will continue to receive Vinflunine or Docetaxel until the participant can commercially receive chemotherapy within the local healthcare system.","label":"Cohort 1 (Arm 1B): Vinflunine or Docetaxel","type":"EXPERIMENTAL"},{"description":"Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-\\[L\\] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs). Participants who enter in LTE phase will continue to receive the erdafitinib tablet as per investigator's decision.","label":"Cohort 2 (Arm 2A): Erdafitinib","type":"EXPERIMENTAL"},{"description":"Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-\\[L\\] 1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities. Participants who enter in LTE phase will continue to receive the pembrolizumab until 2 years after the first dose of pembrolizumab (at start of study) or until the participant can commercially receive pembrolizumab within the local healthcare system, whichever comes first.","label":"Cohort 2 (Arm 2B): Pembrolizumab","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2027-12-31","type":"ESTIMATED"},"conditions":["Urothelial Cancer"],"enrollment":{"count":629,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Erdafitinib","otherNames":["JNJ-42756493"],"type":"DRUG"},{"name":"Vinflunine","otherNames":[],"type":"DRUG"},{"name":"Docetaxel","otherNames":[],"type":"DRUG"},{"name":"Pembrolizumab","otherNames":[],"type":"DRUG"},{"name":"Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)","otherNames":[],"type":"DEVICE"}],"last_update":"2026-09-25","lead_sponsor":"Janssen Research & Development, LLC","official_title":"A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2024-04-15","type":"ACTUAL"},"primary_outcomes":[{"measure":"Overall Survival (OS)","timeFrame":"From randomization (3 days prior to Cycle 1 Day 1) until death due to any cause (maximum up to 51.7 months)"}],"references":[{"citation":"Loriot Y, Matsubara N, Park SH, Huddart RA, Burgess EF, Houede N, Banek S, Guadalupi V, Ku JH, Valderrama BP, Tran B, Triantos S, Kean Y, Akapame S, Deprince K, Mukhopadhyay S, Stone NL, Siefker-Radtke AO; THOR Cohort 1 Investigators. Erdafitinib or Chemotherapy in Advanced or Metastatic Urothelial Carcinoma. N Engl J Med. 2023 Nov 23;389(21):1961-1971. doi: 10.1056/NEJMoa2308849. Epub 2023 Oct 21.","pmid":"37870920","type":"DERIVED"}],"start_date":{"date":"2018-03-23","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations","url":"https://clinicaltrials.gov/study/NCT03390504"},"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/thor-nct03390504"}