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NCT02621151 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Muscle-invasive Urothelial Cancer of the Bladder, sponsored by NYU Langone Health.

Active
Registry status
Phase 2
Development phase
60
Enrollment target
5
Study locations

NCT02621151: Active Phase 2 study of Muscle-invasive Urothelial Cancer of the Bladder, sponsored by NYU Langone Health.

NCT02621151 is a Phase 2 study of Muscle-invasive Urothelial Cancer of the Bladder that is active but no longer recruiting, run by NYU Langone Health. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02621151, a Phase 2 study of Muscle-invasive Urothelial Cancer of the Bladder, is active but no longer recruiting, sponsored by NYU Langone Health.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
60 participants
Enrollment target
5
Study locations

Study 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.

Primary Outcome

Bladder-intact disease-free survival is defined as the time from initiation of protocol therapy until the first occurrence of muscle-invasive bladder cancer recurrence, regional pelvic recurrence, distant metastases, bladder cancer-related death, or cystectomy.

Interventions

  • BIOLOGICAL Pembrolizumab
  • RADIATION External Beam Radiation Therapy
  • DRUG Gemcitabine
  • PROCEDURE Transurethral Resection of Bladder Tumor

Study Locations (5)

New York

  • NYU Perlmutter Cancer Center - New York
  • Memorial Sloan Kettering - New York

Illinois

  • University of Chicago - Chicago

Michigan

  • University of Michigan Health System - Ann Arbor

North Carolina

  • University of North Carolina - Chapel Hill

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2016-08-11
Est. Completion 2025-12
Phase Phase 2
NYU Langone Health

1,164 total trials

What the registry record for NCT02621151 still lists

NCT02621151 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).

The record links to 1 condition, with Muscle-invasive Urothelial Cancer of the Bladder appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.

NCT02621151 lists 5 locations in 4 states (New York, Illinois, Michigan).

Frequently Asked Questions

What is clinical trial NCT02621151 about?

NCT02621151 is a clinical study titled "Pembrolizumab (MK3475), Gemcitabine, and Concurrent Hypofractionated Radiation Therapy for Muscle-Invasive Urothelial Cancer of the Bladder". 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.

What is the current status of trial NCT02621151?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2016-08-11. Estimated completion is 2025-12.

What conditions does trial NCT02621151 study?

This clinical trial studies the following conditions: Muscle-invasive Urothelial Cancer of the Bladder.

What interventions are being tested in trial NCT02621151?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), External Beam Radiation Therapy (RADIATION), Gemcitabine (DRUG), Transurethral Resection of Bladder Tumor (PROCEDURE).

Who is sponsoring clinical trial NCT02621151?

This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02621151 being conducted?

This trial has 5 study locations across Illinois, Michigan, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT02621151's enrollment target sits among peer trials

60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02621151, the US trial registry maintained by the National Library of Medicine. NCT02621151 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.