A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU)

Phase 2 Active not recruiting 154 enrolled AstraZeneca

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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

Timeline

Start: 2018-03-16
Primary completion: 2020-10-15
Completion: 2026-12-31

Outcome

Missed primary endpoint

registry MEDIAN Durva + Olaparib: 4.2 (3.6 to 5.6) Months MEDIAN Durva + Placebo: 3.5 (1.9 to 5.1) Months NCT03459846 ↗

registry analysis (superiority test); Durva + Olaparib vs Durva + Placebo; p = 0.789; Hazard Ratio (HR) 0.94 (95% CI 0.641 to 1.387); NCT03459846 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Durvalumab	Monoclonal antibody	1500 mg	Intravenous
Subject	Olaparib	Small molecule	300 mg	Oral