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 States154 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 range18 Years – 130 Years
SexALL
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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.
✓. Patients with at least 1 RECIST 1.1 target lesion at baseline.
✓. Ability to swallow oral medications.
✓. Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients.
Exclusion criteria
✕. Active or prior documented autoimmune or inflammatory disorders.
✕. Other invasive malignancy within 5 years before the first dose of the IP.
✕
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