NCT03459846

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a Phase II, randomized, double-blind, placebo controlled, multi-center, comparative global study to determine the efficacy and safety of durvalumab + olaparib combination therapy versus durvalumab + placebo (durvalumab monotherapy) as first-line treatment in patients ineligible for platinum-based chemotherapy with unresectable Stage IV urothelial cancer (UC).

Conditions

• Urinary Bladder Neoplasms

Interventions

Type	Name	Description
DRUG	Durvalumab	Durvalumab 1500 mg IV q4w
DRUG	Olaparib	Olaparib PO 300 mg BID adjusted based on patient's creatinine clearance.
DRUG	Placebo	Matching placebo for oral tablet BID

Timeline

• Start date: 2018-03-16
• Primary completion: 2020-10-15
• Completion: 2026-12-31
• First posted: 2018-03-09
• Last updated: 2026-01-30
• Results posted: 2022-10-26

Locations

44 sites across 7 countries: United States, Canada, Russia, South Korea, Spain, Taiwan, Vietnam

Regulatory

• FDA-regulated drug study