At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 108 enrolled
Drug / intervention
Pembrolizumab +1 moredrug
Likely dose
Pembrolizumab 200mgfrom 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 Randomized, Double-blinded, Phase II Study of Maintenance Pembrolizumab Versus Placebo After First-Line Chemotherapy in Patients With Metastatic Urothelial Cancer: Hoosier Cancer Research Network GU14-182
In Brief
A Phase 2 clinical trial evaluating Placebo and Pembrolizumab for Urothelial Carcinoma and Bladder Cancer. Completed, enrolled 108 participants across 28 sites.
Detailed Summary
This is a multi-institutional, randomized, placebo controlled, double-blinded phase II trial of maintenance pembrolizumab versus placebo after first-line chemotherapy in patients with metastatic urothelial cancer who have achieved at least stable disease on first-line chemotherapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrothelial Carcinoma, Bladder Cancer
CountriesUnited States
CollaboratorsHoosier Cancer Research Network, Merck Sharp & Dohme LLC
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 2015
Enrollment StartNov 2015
Primary CompletionJul 2019
Study CompletionJan 2021
TodayJul 2026
First PostedJul 16, 2015
Enrollment StartNov 11, 2015
Primary CompletionJul 1, 2019
Study CompletionJan 1, 2021
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 11.0 years ago
Interventions
Placeboother
Normal saline
Pembrolizumabdrug
Pembrolizumab, 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or for up to 24 months