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

Study identifier:D933IC00003

ClinicalTrials.gov identifier:NCT03459846

EudraCT identifier:2017-004556-27

CTIS identifier:N/A

Recruitment Complete

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

Medical condition

Urinary Bladder Neoplasms

Phase

Phase 2

Healthy volunteers

No

Study drug

Durvalumab, Olaparib, Placebo

Sex

All

Actual Enrollment

154

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 16 Mar 2018
Primary Completion Date: 15 Oct 2020
Estimated Study Completion Date: 31 Dec 2024

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2023 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria