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

NCT02621151 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-10-07

Study results available
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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.

Conditions

  • Muscle-invasive Urothelial Cancer of the Bladder

Interventions

BIOLOGICAL

Pembrolizumab

PROCEDURE

Transurethral Resection of Bladder Tumor

DRUG

Gemcitabine

RADIATION

External Beam Radiation Therapy

Sponsors & Collaborators

Principal Investigators

  • Minas Economides, MD · NYU Langone Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-11
Primary Completion
2022-11-10
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02621151 on ClinicalTrials.gov