{"preliminary_commentary":{"by_channel":{"x_thread":2,"youtube":1},"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,"drugs_tested":null,"indication":"previously untreated, platinum-ineligible metastatic urothelial carcinoma","name":"BAYOU","nct_id":"NCT03459846","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=bayou-nct03459846. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. 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_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"BAYOU","arms":[{"description":"Durvalumab 1500 mg intravenous (IV) every 4 weeks (q4w) starting on week 1 day 1/Placebo orally (PO) twice a day (BID) starting on week 1 day 1.","label":"Arm 1: Durvalumab/Placebo","type":"EXPERIMENTAL"},{"description":"Durvalumab 1500 mg IV q4w starting on week 1 day 1/Olaparib PO 300 mg BID adjusted based on patient's creatinine clearance.","label":"Arm 2: Durvalumab/Olaparib","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2026-12-31","type":"ESTIMATED"},"conditions":["Urinary Bladder Neoplasms"],"enrollment":{"count":154,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Durvalumab","otherNames":[],"type":"DRUG"},{"name":"Olaparib","otherNames":[],"type":"DRUG"},{"name":"Placebo","otherNames":[],"type":"DRUG"}],"last_update":"2026-08-05","lead_sponsor":"AstraZeneca","official_title":"A Phase II, Randomized, Multi-Center, Double-Blind, Comparative Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Olaparib for First-Line Treatment in Platinum-Ineligible Patients With Unresectable Stage IV Urothelial Cancer","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2020-10-15","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-free Survival (PFS)","timeFrame":"Assessments performed at baseline and every 8 weeks from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), assessed up to the data cut-off date (15 Oct 2020), up to a max. of 31 months"}],"references":[{"citation":"Rosenberg JE, Park SH, Kozlov V, Dao TV, Castellano D, Li JR, Mukherjee SD, Howells K, Dry H, Lanasa MC, Stewart R, Bajorin DF. Durvalumab Plus Olaparib in Previously Untreated, Platinum-Ineligible Patients With Metastatic Urothelial Carcinoma: A Multicenter, Randomized, Phase II Trial (BAYOU). J Clin Oncol. 2023 Jan 1;41(1):43-53. doi: 10.1200/JCO.22.00205. Epub 2022 Jun 23.","pmid":"35737919","type":"DERIVED"}],"start_date":{"date":"2018-03-16","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU)","url":"https://clinicaltrials.gov/study/NCT03459846"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/bayou-nct03459846"}