At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 39 enrolled
Drug / intervention
pembrolizumab, gemcitabine and cisplatindrug
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.
Phase II Single Arm Study of Gemcitabine and Cisplatin Plus Pembrolizumab as Neoadjuvant Therapy Prior to Radical Cystectomy in Patients With Muscle-Invasive Bladder Cancer
In Brief
A Phase 2 clinical trial evaluating pembrolizumab, gemcitabine and cisplatin for Bladder Cancer. Completed, enrolled 39 participants across 2 sites.
Detailed Summary
The purpose of this study is to evaluate whether adding pembrolizumab (Keytruda) to the combination of gemcitabine and cisplatin will improve shrinkage of the tumor before having a cystectomy, for people with muscle-invasive bladder cancer (MIBC).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBladder Cancer
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 2016
Enrollment StartMay 2016
Primary CompletionJul 2020
Study CompletionJan 2026
TodayJul 2026
First PostedFeb 24, 2016
Enrollment StartMay 1, 2016
Primary CompletionJul 6, 2020
Study CompletionJan 30, 2026
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 10.4 years ago
Interventions
pembrolizumab, gemcitabine and cisplatindrug
neoadjuvant administration of pembrolizumab with gemcitabine and cisplatin prior to cystectomy