Pembrolizumab (MK3475), Gemcitabine, and Concurrent Hypofractionated Radiation Therapy for Muscle-Invasive Urothelial Cancer of the Bladder
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- NYU Langone Health
- Study ID
- NCT02621151
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
- Muscle-invasive Urothelial Cancer of the Bladder
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Pembrolizumab — BIOLOGICAL
- Transurethral Resection of Bladder Tumor — PROCEDURE
- Gemcitabine — DRUG
- External Beam Radiation Therapy — RADIATION
Study Details
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.
Key Dates
- Start date
- Aug 11, 2016
- Status verified
- Sep 2025
- Primary completion
- Nov 10, 2022
- Completion
- Dec 31, 2025
Study Design
- Enrollment
- 60 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Pembrolizumab, Gemcitabine, and RT* Lead-in single dose Pembrolizumab 200 mg, intravenously (IV) * Transurethral Resection of Bladder Tumor (TURBT) at pre-RT (maximal) and completion of therapy (diagnostic) * External Beam Radiation Therapy (EBRT) - 52 Gy in 20 fractions over 4 weeks (1 fraction = 2.6 Gy) * Gemcitabine 27 mg/m\^2 IV twice weekly for 4 weeks concurrent with EBRT * Pembrolizumab 200 mg IV every 3 weeks for total 3 doses starting day 1 of EBRT
Primary Outcome Measure
Percentage of Participants Who Achieved Two-year Bladder-intact Disease-free Survival [ Time Frame: 2 years ]
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | - |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | - |
| Memorial Sloan Kettering | New York | New York | 10065 | - |
| NYU Perlmutter Cancer Center | New York | New York | 10016 | - |
| University of North Carolina | Chapel Hill | North Carolina | 27599-7305 | - |
Related coverage on Hipa.ai
- Pembrolizumab + Gemcitabine/RT for Bladder Cancer Shows 60% 2-Year…Pembrolizumab · Oct 7, 2025 · ClinicalTrials.gov