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Pembrolizumab (MK3475), Gemcitabine, and Concurrent Hypofractionated Radiation Therapy for Muscle-Invasive Urothelial Cancer of the Bladder

StatusCompleted
PhasePhase 2
Started2016-08-11
View on ClinicalTrials.gov ↗

Amendment history

2026-10-01
Trial completed
2025-09-17
Study Status, Outcome Measures, Contacts/Locations, IPDSharing, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v13
Primary completion dateestimated 2025-12→confirmed 2022-11-10
Results first postednot stated→2025-10-07
Secondary endpoints4 to 3 entries
Safety (adverse events) of the protocol therapy Complete responseResponse (CR) rateRate OverallPercentage survivalof Participants Who Survived at Study Completion Percentage of Participants Who Achieved Metastasis-free survivalSurvival at Study Completion
Primary endpoints1 entry, revised
Percentage of Participants Who Achieved Two-year bladderBladder-intact diseaseDisease-free survival rateSurvival
2024-10-24
3 amendments v10-v12
3 re-verifications since 2022-12-01, no change to tracked fields
2021-12-01
Study Status, Study Design, Contacts/Locations v9
Enrollment target54→60
2021-01-05
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v8
Trial statusRecruiting→Active, Not Recruiting
Completion date2026-12→2025-12
Study sitesdetails revised at 5 of 5 sites
Show 7 earlier versions
2019-12-02
Study Status v7
Re-verified, no change to tracked fields
2018-12-18
Study Status, Contacts/Locations v6
Start date2014-10→2016-08-11
Study sites4→5
2018-11-19
Study Status v5
Primary completion date2021-05→2025-12
Completion date2024-05→2026-12
2017-11-17
Study Status, Contacts/Locations v4
Study sites1→4
2016-12-30
Study Identification, Study Status v3
Re-verified, no change to tracked fields
2016-06-23
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start date2016-03→2014-10
Study sitesdetails revised at 1 of 1 site
2015-12-30
Study Status v1
Re-verified, no change to tracked fields
2015-12-02
Original filing
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.
Trial Details
NCT Number NCT02621151
Lead Sponsor NYU Langone Health
Collaborators: Merck Sharp & Dohme LLC
Conditions Muscle-invasive Urothelial Cancer of the Bladder
Enrollment 60 participants
Start Date 2016-08-11
Primary Completion 2022-11-10 (estimated)
Study Completion 2025-12-15 (estimated)
Updated on ClinicalTrials.gov 2026-09-30