A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Canc… (NCT03459846) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU)
United States, Canada, Russia154 participantsStarted 2018-03-16
Plain-language 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
Who can participate
Age range
18 Years – 130 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Provision of signed and dated, written ICF
. Histologically or cytologically documented TCC/UC of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra) also meeting the following: Unresectable, Stage IV disease; No prior systemic therapy for unresectable, Stage IV disease.
. Ineligible for platinum-based chemotherapy defined as (i) in the opinion of the Investigator, unfit for carboplatin-based chemotherapy and (ii) meeting one of the following criteria: CrCl \<60 mL/min calculated by Cockcroft-Gault equation; Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 audiometric hearing loss (25 dB in 2 consecutive wave ranges); CTCAE Grade ≥2 peripheral neuropathy; New York Heart Association Class III heart failure; ECOG 2.
. Known tumor HRR mutation status prior to randomization.
. World Health Organization (WHO)/ECOG performance status of 0, 1, or 2.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since BAYOU is a Phase 2 trial testing durvalumab alone versus durvalumab combined with olaparib, what do the results so far suggest about whether the combination offers any real benefit over immunotherapy alone for my type of bladder cancer?
2This trial is specifically for patients who can't receive platinum-based chemotherapy — given my situation, does my doctor agree I'm platinum-ineligible, and does that make this trial's approach more or less relevant compared to other options available to me?
3The trial's main goal is to measure how long patients go without their cancer progressing — based on what's been published or presented from BAYOU so far, what does progression-free survival look like, and how does that compare to standard treatment alternatives?
4Since the trial is no longer enrolling new patients, is there any way to still access durvalumab or olaparib through other studies, expanded access programs, or approved uses that might be worth discussing for my case?
5Olaparib works partly by targeting DNA repair defects — does my tumor have any genetic features, like HRD or specific mutations, that might influence whether the durvalumab-plus-olaparib combination would be worth pursuing over other treatments?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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