{"commentary":{"count":4,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":2,"youtube":1,"podcast":1},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":false},"name":"FORT-2","nct_id":"NCT03473756","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=fort-2-nct03473756. The price is fixed at order. We build the report after 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: 1–12 commentary sources"},"registry":{"acronym":"FORT-2","arms":[{"description":"Part A: Part A is conducted in patients who are cisplatin-ineligible and have had no prior systemic treatment for locally advanced or metastatic disease.\n\nPatients will receive rogaratinib plus atezolizumab combination treatment.","label":"Rogaratinib + Atezolizumab in Part A","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2024-07-10","type":"ACTUAL"},"conditions":["Urothelial Carcinoma"],"enrollment":{"count":37,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Rogaratinib (BAY1163877)","type":"DRUG"},{"name":"Atezolizumab","type":"DRUG"}],"last_update":"2025-04-09","lead_sponsor":"Bayer","official_title":"An International, Multicenter, Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab as First-line Treatment in Cisplatin-ineligible Patients With FGFR-positive Locally Advanced or Metastatic Urothelial Carcinoma","overall_status":"COMPLETED","phases":["PHASE1"],"primary_completion_date":{"date":"2021-07-16","type":"ACTUAL"},"primary_outcomes":[{"measure":"Number of Participants With Dose-limiting Toxicities(DLTs)","timeFrame":"Up to 21 days"},{"measure":"Number of Participants With Treatment-emergent Adverse Events (TEAEs)","timeFrame":"up to 90 days after the last study medication intake, an average of 60 days"},{"measure":"Number of Participants With Drug-related TEAEs","timeFrame":"up to 90 days after the last study medication intake, an average of 60 days"},{"measure":"Number of Participants With Treatment-emergent Serious Adverse Events(TESAEs)","timeFrame":"up to 90 days after the last study medication intake, an average of 60 days"}],"references":[{"citation":"Sweis RF, Gajate P, Morales-Barrera R, Lee JL, Necchi A, de Braud F, Penel N, Grunwald V, Maruzzo M, Meran J, Ishida TC, Bao W, Zhou Y, Ellinghaus P, Rosenberg JE. Rogaratinib Plus Atezolizumab in Cisplatin-Ineligible Patients With FGFR RNA-Overexpressing Urothelial Cancer: The FORT-2 Phase 1b Nonrandomized Clinical Trial. JAMA Oncol. 2024 Nov;10(11):1565-1570. doi: 10.1001/jamaoncol.2024.3900. Epub 2024 Sep 19.","pmid":"39298147","type":"DERIVED"},{"citation":"Grunewald S, Politz O, Bender S, Heroult M, Lustig K, Thuss U, Kneip C, Kopitz C, Zopf D, Collin MP, Boemer U, Ince S, Ellinghaus P, Mumberg D, Hess-Stumpp H, Ziegelbauer K. Rogaratinib: A potent and selective pan-FGFR inhibitor with broad antitumor activity in FGFR-overexpressing preclinical cancer models. Int J Cancer. 2019 Sep 1;145(5):1346-1357. doi: 10.1002/ijc.32224. Epub 2019 Mar 13.","pmid":"30807645","type":"DERIVED"}],"start_date":{"date":"2018-05-15","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab in Urothelial Carcinoma","url":"https://clinicaltrials.gov/study/NCT03473756"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/fort-2-nct03473756"}