{"entity":{"id":"nct03459846","kind":"trial","name":"A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU)","aka":["BAYOU"],"tldr":"A phase 2 trial of Durvalumab and Olaparib in bladder & urothelial cancer, run by AstraZeneca, active and no longer recruiting.","summary":"A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU) is a phase 2 interventional study registered as NCT03459846 by AstraZeneca, with 154 participants enrolled, started 2018-03-16 and due to reach its primary completion in 2020-10-15. Interventions recorded: Durvalumab, Olaparib and Placebo. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03459846","url":"https://clinicaltrials.gov/study/NCT03459846"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","parp-inhibitor"],"targets":[],"drugs":["durvalumab","olaparib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03459846","phase":"2","setting":"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","sponsor":"AstraZeneca","started":"2018-03-16","startedType":"actual","yearReported":2022,"enrolled":154,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free Survival (PFS)","primary":true,"unit":"months","arms":[{"name":"Durva + Olaparib","n":78,"value":4.2,"note":"95% CI 3.6 to 5.6; Figures from the ClinicalTrials.gov results section (first posted 2022-10-26), not from a publication"},{"name":"Durva + Placebo","n":76,"value":3.5,"note":"95% CI 1.9 to 5.1"}],"hr":0.94,"ci":[0.641,1.387],"p":"0.789","source":"https://clinicaltrials.gov/study/NCT03459846?tab=results"}]},"route":"/trials/nct03459846/","neighbours":{"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"},{"id":"muscle-invasive-bladder-cancer","kind":"cancer","name":"Muscle-invasive and advanced bladder cancer","route":"/cancers/muscle-invasive-bladder-cancer/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"},{"id":"parp-inhibitor","kind":"technology","name":"PARP inhibitors","route":"/technologies/parp-inhibitor/"}],"drug":[{"id":"durvalumab","kind":"drug","name":"Durvalumab","route":"/drugs/durvalumab/"},{"id":"olaparib","kind":"drug","name":"Olaparib","route":"/drugs/olaparib/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}]}}