Study identifier:D933IC00003
ClinicalTrials.gov identifier:NCT03459846
EudraCT identifier:2017-004556-27
CTIS identifier:N/A
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
Urinary Bladder Neoplasms
Phase 2
No
Durvalumab, Olaparib, Placebo
All
154
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jul 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Arm 1: Durvalumab/Placebo Durvalumab 1500 mg intravenous (IV) every 4 weeks (q4w) starting on week 1 day 1/Placebo orally (PO) twice a day (BID) starting on week 1 day 1. | Drug: Durvalumab Durvalumab 1500 mg IV q4w Drug: Placebo Matching placebo for oral tablet BID |
Experimental: Arm 2: Durvalumab/Olaparib Durvalumab 1500 mg IV q4w starting on week 1 day 1/Olaparib PO 300 mg BID adjusted based on patient's creatinine clearance. | Drug: Durvalumab Durvalumab 1500 mg IV q4w Drug: Olaparib Olaparib PO 300 mg BID adjusted based on patient's creatinine clearance. |