At a glance
ClinicalIndex Comparison RecordPhase 2Active· 60 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 II Trial of MK3475 in Combination With Gemcitabine and Concurrent Hypofractionated Radiation Therapy as Bladder Sparing Treatment for Muscle-Invasive Urothelial Cancer of the Bladder
In Brief
A Phase 2 clinical trial evaluating Pembrolizumab, Transurethral Resection of Bladder Tumor, and 2 other interventions for Muscle-invasive Urothelial Cancer of the Bladder. Active but no longer recruiting, targeting 60 participants across 5 sites.
Detailed Summary
This trial is to assess the efficacy of pembrolizumab (MK3475) added to concurrent radiation and gemcitabine in the management of patients with muscle-invasive urothelial cancer who are not candidates for or decline radical cystectomy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC
Timeline
Phase 2ActiveOverdue
20162017201820192020202120222023202420252026
First PostedDec 2015
Enrollment StartAug 2016
Primary CompletionNov 2022
Study CompletionDec 2025
TodayJul 2026
First PostedDec 3, 2015
Enrollment StartAug 11, 2016
Primary CompletionNov 10, 2022
Study CompletionDec 1, 2025
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 10.6 years ago
Interventions
Pembrolizumabbiological
Transurethral Resection of Bladder Tumorprocedure
Gemcitabinedrug
External Beam Radiation Therapyradiation