{"preliminary_commentary":{"by_channel":{"youtube":2,"x_thread":2},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"name":"ECOG-ACRIN EA8231","nct_id":"NCT06524544","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=ecog-acrin-ea8231-nct06524544. 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":"Patients receive TPC with carboplatin or cisplatin IV on day 1 and gemcitabine IV on days 1 and 8 of each cycle. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients may alternately receive TPC with docetaxel IV on day 1 of each cycle or paclitaxel IV on either day 1 or days 1, 8, and 15 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection and CT or MRI throughout the study.","label":"Arm I (TPC chemotherapy)","type":"ACTIVE_COMPARATOR"},{"description":"Patients receive pembrolizumab IV over 30 minutes on day 1 and sacituzumab govitecan-hziy IV over 1-3 hours on days 1 and 8 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, and CT or MRI throughout the study.","label":"Arm II (pembrolizumab, sacituzumab govitecan-hziy)","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2030-12-31","type":"ESTIMATED"},"conditions":["Locally Advanced Urothelial Carcinoma","Metastatic Urothelial Carcinoma","Unresectable Urothelial Carcinoma"],"enrollment":{"count":320,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Biospecimen Collection","otherNames":["Biological Sample Collection","Biospecimen Collected","Sample Collection","Specimen Collection"],"type":"PROCEDURE"},{"name":"Carboplatin","otherNames":["Blastocarb","Carboplat","Carboplatin Hexal","Carboplatino","Carboplatinum","Carbosin","Carbosol","Carbotec","CBDCA","Displata","Ercar","JM-8","JM8","Nealorin","Novoplatinum","Paraplatin","Paraplatin AQ","Paraplatine","Platinwas","Ribocarbo"],"type":"DRUG"},{"name":"Cisplatin","otherNames":["Abiplatin","Blastolem","Briplatin","CDDP","Cis-diammine-dichloroplatinum","Cis-diamminedichloridoplatinum","Cis-diamminedichloro Platinum (II)","Cis-diamminedichloroplatinum","Cis-dichloroammine Platinum (II)","Cis-platinous Diamine Dichloride","Cis-platinum","Cis-platinum II","Cis-platinum II Diamine Dichloride","Cismaplat","Cisplatina","Cisplatinum","Cisplatyl","Citoplatino","Citosin","Cysplatyna","DDP","Lederplatin","Metaplatin","Neoplatin","Peyrone's Chloride","Peyrone's Salt","Placis","Plastistil","Platamine","Platiblastin","Platiblastin-S","Platinex","Platinol","Platinol- AQ","Platinol-AQ","Platinol-AQ VHA Plus","Platinoxan","Platinum","Platinum Diamminodichloride","Platiran","Platistin","Platosin"],"type":"DRUG"},{"name":"Computed Tomography","otherNames":["CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan","Diagnostic CAT Scan","Diagnostic CAT Scan Service Type","tomography"],"type":"PROCEDURE"},{"name":"Docetaxel","otherNames":["Docecad","RP 56976","RP-56976","RP56976","Taxotere","Taxotere Injection Concentrate"],"type":"DRUG"},{"name":"Gemcitabine","otherNames":["dFdC","dFdCyd","Difluorodeoxycytidine"],"type":"DRUG"},{"name":"Magnetic Resonance Imaging","otherNames":["Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging","sMRI","Structural MRI"],"type":"PROCEDURE"},{"name":"Paclitaxel","otherNames":["Anzatax","Asotax","Bristaxol","Praxel","Taxol","Taxol Konzentrat"],"type":"DRUG"},{"name":"Pembrolizumab","otherNames":["BCD-201","GME 751","GME751","Keytruda","Lambrolizumab","MK 3475","MK-3475","MK3475","Pembrolizumab Biosimilar BCD-201","Pembrolizumab Biosimilar GME751","Pembrolizumab Biosimilar QL2107","Pembrolizumab Biosimilar RPH-075","Pembrolizumab Biosimilar SB27","QL2107","RPH 075","RPH-075","RPH075","SB 27","SB-27","SB27","SCH 900475","SCH-900475","SCH900475"],"type":"BIOLOGICAL"},{"name":"Questionnaire Administration","otherNames":[],"type":"OTHER"},{"name":"Sacituzumab Govitecan","otherNames":["hRS7-SN38 Antibody Drug Conjugate","IMMU 132","IMMU-132","IMMU132","RS7 SN38","RS7-SN38","RS7SN38","Sacituzumab Govitecan-hziy","Trodelvy"],"type":"BIOLOGICAL"}],"last_update":"2026-10-05","lead_sponsor":"National Cancer Institute (NCI)","official_title":"A Phase III Randomized Trial of Pembrolizumab in Combination With Sacituzumab Govitecan-hziy vs Standard of Care in Anti-PD(L)1-Resistant Advanced Urothelial Cancer","overall_status":"RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2030-12-31","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Overall survival (OS)","timeFrame":"From randomization to death due to any cause, assessed up to 5 years"}],"references":[],"start_date":{"date":"2025-12-02","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study Comparing the Combination of Pembrolizumab and Sacituzumab Govitecan-hziy Versus Standard of Care in the Treatment of Advanced Urothelial Cancer","url":"https://clinicaltrials.gov/study/NCT06524544"},"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/ecog-acrin-ea8231-nct06524544"}