At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 542 enrolled
Drug / intervention
pembrolizumab +3 morebiological
Likely dose
Not stated in 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 III Randomized Clinical Trial of Pembrolizumab (MK-3475) Versus Paclitaxel, Docetaxel or Vinflunine in Subjects With Recurrent or Progressive Metastatic Urothelial Cancer
In Brief
A Phase 3 clinical trial evaluating pembrolizumab, paclitaxel, and 2 other interventions for Urothelial Cancer. Completed, enrolled 542 participants.
Detailed Summary
Participants with metastatic or locally advanced/unresectable urothelial cancer that has recurred or progressed following platinum-based chemotherapy will be randomly assigned to receive Investigator's choice of paclitaxel, docetaxel, or vinflunine (Control), or pembrolizumab. The primary study hypotheses are that pembrolizumab will prolong Overall Survival (OS) and Progression-free Survival (PFS) compared to paclitaxel, docetaxel, or vinflunine.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrothelial Cancer
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 2014
Enrollment StartOct 2014
Primary CompletionSep 2016
Study CompletionOct 2020
TodayJul 2026
First PostedOct 3, 2014
Enrollment StartOct 22, 2014
Primary CompletionSep 7, 2016
Study CompletionOct 1, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 11.7 years ago
Interventions
pembrolizumabbiological
IV infusion
paclitaxeldrug
IV infusion
vinfluninedrug
IV infusion
docetaxeldrug
IV infusion