At a glance
ClinicalIndex Comparison RecordPhase 2Active· 154 enrolled
Drug / intervention
Durvalumab +2 moredrug
Likely dose
Durvalumab 1500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Durvalumab, Olaparib, and 1 other intervention for Urinary Bladder Neoplasms. Active but no longer recruiting, targeting 154 participants across 44 sites in 7 countries.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Bladder Neoplasms
CountriesCanada, Russia, South Korea, Spain, Taiwan, United States, Vietnam
Collaborators--
Timeline
Phase 2Active
2018201920202021202220232024202520262027
First PostedMar 2018
Enrollment StartMar 2018
Primary CompletionOct 2020
TodayJul 2026
Study CompletionDec 2026
First PostedMar 9, 2018
Enrollment StartMar 16, 2018
Primary CompletionOct 15, 2020
Study CompletionDec 31, 2026
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 8.3 years ago
Interventions
Durvalumabdrug
Durvalumab 1500 mg IV q4w
Olaparibdrug
Olaparib PO 300 mg BID adjusted based on patient's creatinine clearance.
Placebodrug
Matching placebo for oral tablet BID