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NCT03854474 · ClinicalTrials.gov registry record · Phase 1

Testing the Addition of Tazemetostat to the Immunotherapy Drug, Pembrolizumab (MK-3475), in Advanced Urothelial Carcinoma

A Phase 1 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 1
Development phase
30
Enrollment target
20
Study locations

NCT03854474 is a Phase 1 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 30 participants, below the 130-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 5 states.

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The verdict

NCT03854474, a Phase 1 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
30 participants
Enrollment target
20
Study locations

Study Summary

This phase I/II trial studies the side effects and best dose of tazemetostat and how well it works when given together with pembrolizumab in treating patients with urothelial carcinoma that has spread to nearby tissue or lymph nodes (locally advanced ) or from where it first started (primary site) to other places in the body (metastatic). Tazemetostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving tazemetostat and pembrolizumab may work better in treating patients with urothelial carcinoma compared to pembrolizumab without tazemetostat.

Conditions Studied

Metastatic Urothelial Carcinoma Locally Advanced Urothelial Carcinoma Stage IV Bladder Cancer AJCC v8 Stage III Bladder Cancer AJCC v8

Interventions

  • BIOLOGICAL Pembrolizumab
  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Magnetic Resonance Imaging
  • DRUG Tazemetostat

Study Locations (20)

Connecticut

  • Smilow Cancer Hospital-Derby Care Center - Derby
  • Smilow Cancer Hospital Care Center-Fairfield - Fairfield
  • Smilow Cancer Hospital Care Center - Guilford - Guilford
  • Smilow Cancer Hospital Care Center at Saint Francis - Hartford
  • Smilow Cancer Center/Yale-New Haven Hospital - New Haven
  • Yale University - New Haven
  • Yale-New Haven Hospital North Haven Medical Center - North Haven
  • Smilow Cancer Hospital-Orange Care Center - Orange
  • Smilow Cancer Hospital-Torrington Care Center - Torrington
  • Smilow Cancer Hospital Care Center-Trumbull - Trumbull
  • Smilow Cancer Hospital-Waterbury Care Center - Waterbury
  • Smilow Cancer Hospital Care Center - Waterford - Waterford

Kansas

  • University of Kansas Clinical Research Center - Fairway
  • HaysMed - Hays
  • Lawrence Memorial Hospital - Lawrence
  • The University of Kansas Cancer Center - Olathe - Olathe

Arizona

  • Mayo Clinic Hospital in Arizona - Phoenix
  • Mayo Clinic in Arizona - Scottsdale

Florida

  • Mayo Clinic in Florida - Jacksonville

Illinois

  • Northwestern University - Chicago

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2019-11-18
Est. Completion 2026-06-30
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03854474

The ClinicalTrials.gov registry entry for NCT03854474 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 130-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (77% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Metastatic Urothelial Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.

NCT03854474 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Connecticut, Kansas, Arizona.

Frequently Asked Questions

What is clinical trial NCT03854474 about?

NCT03854474 is a clinical study titled "Testing the Addition of Tazemetostat to the Immunotherapy Drug, Pembrolizumab (MK-3475), in Advanced Urothelial Carcinoma". This phase I/II trial studies the side effects and best dose of tazemetostat and how well it works when given together with pembrolizumab in treating patients with urothelial carcinoma that has spread to nearby tissue or lymph nodes (locally advanced ) or from where it first started (primary site) t...

What is the current status of trial NCT03854474?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2019-11-18. Estimated completion is 2026-06-30.

What conditions does trial NCT03854474 study?

This clinical trial studies the following conditions: Metastatic Urothelial Carcinoma, Locally Advanced Urothelial Carcinoma, Stage IV Bladder Cancer AJCC v8, Stage III Bladder Cancer AJCC v8.

What interventions are being tested in trial NCT03854474?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Tazemetostat (DRUG).

Who is sponsoring clinical trial NCT03854474?

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

Where is trial NCT03854474 being conducted?

This trial has 20 study locations across Arizona, Connecticut, Florida, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.