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NCT03244384 · ClinicalTrials.gov registry record · Phase 3

Testing MK-3475 (Pembrolizumab) After Surgery for Localized Muscle-Invasive Bladder Cancer and Locally Advanced Urothelial Cancer

A Phase 3 study of Locally Advanced Urothelial Carcinoma and Locally Advanced Bladder Urothelial Carcinoma, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 3
Development phase
739
Enrollment target
20
Study locations

NCT03244384: Active Phase 3 study of Locally Advanced Urothelial Carcinoma and Locally Advanced Bladder Urothelial Carcinoma, sponsored by National Cancer Institute (NCI).

NCT03244384 is a Phase 3 study of Locally Advanced Urothelial Carcinoma and Locally Advanced Bladder Urothelial Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 739 participants, above the 74-participant average among 14 other Locally Advanced Urothelial Carcinoma trials with a reported enrollment target (899% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03244384, a Phase 3 study of Locally Advanced Urothelial Carcinoma and Locally Advanced Bladder Urothelial Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
739 participants
Enrollment target
20
Study locations

Study Summary

This phase III trial studies how well pembrolizumab works in treating patients with bladder cancer that has spread into the deep muscle of the bladder wall (muscle-invasive) or urothelial cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). Monoclonal antibodies recognizing and blocking checkpoint molecules can enhance the patient's immune response and therefore help fight cancer. Pembrolizumab is one of the monoclonal antibodies that block the PD-1 axis and can interfere with the ability of tumor cells to grow.

Primary Outcome

The stratified proportional hazards model will be the primary analysis. The hazard ratio and its 95% confidence interval from the stratified Cox model with a single treatment covariate will be reported. The unstratified hazard ratio will also be presented.

Conditions Studied

Locally Advanced Urothelial Carcinoma Locally Advanced Bladder Urothelial Carcinoma Locally Advanced Ureter Urothelial Carcinoma Stage III Bladder Urothelial Carcinoma AJCC v6 and v7 Stage II Bladder Urothelial Carcinoma AJCC v6 and v7 Locally Advanced Renal Pelvis and Ureter Urothelial Carcinoma Localized Renal Pelvis and Ureter Urothelial Carcinoma Stage II Ureter Cancer AJCC v7 Stage II Renal Pelvis and Ureter Cancer AJCC v7 Stage III Renal Pelvis and Ureter Cancer AJCC v7

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • OTHER Clinical Observation
  • PROCEDURE Cystoscopy
  • PROCEDURE CT Urography

Study Locations (20)

Alaska

  • Anchorage Associates in Radiation Medicine - Anchorage
  • Anchorage Radiation Therapy Center - Anchorage
  • Alaska Breast Care and Surgery LLC - Anchorage
  • Alaska Oncology and Hematology LLC - Anchorage
  • Alaska Women's Cancer Care - Anchorage
  • Anchorage Oncology Centre - Anchorage
  • Katmai Oncology Group - Anchorage
  • Providence Alaska Medical Center - Anchorage
  • Fairbanks Memorial Hospital - Fairbanks

Arizona

  • CTCA at Western Regional Medical Center - Goodyear
  • Kingman Regional Medical Center - Kingman
  • Cancer Center at Saint Joseph's - Phoenix
  • Mayo Clinic Hospital in Arizona - Phoenix
  • Mayo Clinic in Arizona - Scottsdale

Arkansas

  • Mercy Hospital Fort Smith - Fort Smith
  • CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
  • John L McClellan Memorial Veterans Hospital - Little Rock

California

  • Kaiser Permanente-Anaheim - Anaheim
  • Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande

Alabama

  • University of Alabama at Birmingham Cancer Center - Birmingham

Trial Details

FieldValue
Enrollment Target 739 participants
Start Date 2017-11-03
Est. Completion 2026-06-01
Phase Phase 3
National Cancer Institute (NCI)

3,257 total trials

What the registry record for NCT03244384 still lists

NCT03244384 is an interventional study that assigns participants to a tested intervention. The registered 739 participants enrollment target is mid-sized for trials with a published cap, above the 74-participant average among 14 other Locally Advanced Urothelial Carcinoma trials with a reported enrollment target (899% higher).

The record links to 10 conditions, with Locally Advanced Urothelial Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT03244384 names 20 study sites across 5 states, led by Alaska, Arizona, Arkansas.

Frequently Asked Questions

What is clinical trial NCT03244384 about?

NCT03244384 is a clinical study titled "Testing MK-3475 (Pembrolizumab) After Surgery for Localized Muscle-Invasive Bladder Cancer and Locally Advanced Urothelial Cancer". This phase III trial studies how well pembrolizumab works in treating patients with bladder cancer that has spread into the deep muscle of the bladder wall (muscle-invasive) or urothelial cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). Monoclonal anti...

What is the current status of trial NCT03244384?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 739 participants. The study started on 2017-11-03. Estimated completion is 2026-06-01.

What conditions does trial NCT03244384 study?

This clinical trial studies the following conditions: Locally Advanced Urothelial Carcinoma, Locally Advanced Bladder Urothelial Carcinoma, Locally Advanced Ureter Urothelial Carcinoma, Stage III Bladder Urothelial Carcinoma AJCC v6 and v7, Stage II Bladder Urothelial Carcinoma AJCC v6 and v7.

What interventions are being tested in trial NCT03244384?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Clinical Observation (OTHER), Cystoscopy (PROCEDURE), CT Urography (PROCEDURE).

Who is sponsoring clinical trial NCT03244384?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03244384 being conducted?

This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Locally Advanced Urothelial Carcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03244384's enrollment target sits among peer trials

739 1st of 14 higher than 14 of 14 other Locally Advanced Urothelial Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Locally Advanced Urothelial Carcinoma 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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Related registry views

Source: ClinicalTrials.gov NCT03244384, the US trial registry maintained by the National Library of Medicine. NCT03244384 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.