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NCT05714202 · ClinicalTrials.gov registry record · Phase 3

A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC)

A Phase 3 study of Bladder Cancer, sponsored by Janssen Research & Development.

Active
Registry status
Phase 3
Development phase
1,135
Enrollment target
20
Study locations

NCT05714202 is a Phase 3 study of Bladder Cancer that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 1,135 participants, below the 12,747-participant average among 175 other Bladder Cancer trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 8 states.

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The verdict

NCT05714202, a Phase 3 study of Bladder Cancer, is active but no longer recruiting, sponsored by Janssen Research & Development.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
1,135 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to compare event-free survival (EFS) in participants with Bacillus Calmette-Guerin (BCG)-naive high-risk non-muscle invasive bladder cancer (HR-NMIBC), including high-grade papillary Ta, any T1, or carcinoma in situ (CIS), between TAR-200 plus cetrelimab (Group A) and TAR-200 alone (Group C) versus intravesical BCG (Group B).

Conditions Studied

Interventions

  • DRUG TAR-200
  • BIOLOGICAL Cetrelimab
  • BIOLOGICAL BCG Vesiculture

Study Locations (20)

California

  • VA Long Beach Health Care System - Long Beach
  • Genesis Research, LLC - West Coast Urology - Los Alamitos
  • Cedars Sinai Medical Center - Los Angeles
  • UC Davis Comprehensive Cancer Center - Sacramento
  • Genesis Research - San Diego
  • Providence Saint Johns Cancer Institute - Santa Monica
  • Providence Medical Foundation - Santa Rosa

Florida

  • Urological Research Network - Hialeah
  • Orlando Health Cancer Institute - Orlando
  • Sarasota Memorial Hospital - Sarasota

Illinois

  • Northwestern University - Chicago
  • Duly Health and Care - Lisle
  • Blessing Hospital - Quincy

Georgia

  • Grady Memorial Hospital - Atlanta
  • The Emory Clinic Department of Urology - Atlanta

Indiana

  • Urology of Indiana - Carmel
  • First Urology - Jeffersonville

Arizona

  • Mayo Clinic - Scottsdale

Arkansas

  • Arkansas Urology - Little Rock

Colorado

  • Colorado Clinical Research - Lakewood

Trial Details

FieldValue
Enrollment Target 1,135 participants
Start Date 2023-03-23
Est. Completion 2029-09-18
Phase Phase 3

Sponsor

Janssen Research & Development

593 total trials

What the Registry Record Tells You About NCT05714202

The ClinicalTrials.gov registry entry for NCT05714202 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,135 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,747-participant average among 175 other Bladder Cancer trials with a reported enrollment target (91% lower). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Bladder Cancer appearing as the primary indexed condition, and to 3 interventions - of which TAR-200 is the first listed.

NCT05714202 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Florida, Illinois.

Frequently Asked Questions

What is clinical trial NCT05714202 about?

NCT05714202 is a clinical study titled "A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC)". The purpose of this study is to compare event-free survival (EFS) in participants with Bacillus Calmette-Guerin (BCG)-naive high-risk non-muscle invasive bladder cancer (HR-NMIBC), including high-grade papillary Ta, any T1, or carcinoma in situ (CIS), between TAR-200 plus cetrelimab (Group A) and TA...

What is the current status of trial NCT05714202?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,135 participants. The study started on 2023-03-23. Estimated completion is 2029-09-18.

What conditions does trial NCT05714202 study?

This clinical trial studies the following conditions: Bladder Cancer.

What interventions are being tested in trial NCT05714202?

The interventions under investigation include: TAR-200 (DRUG), Cetrelimab (BIOLOGICAL), BCG Vesiculture (BIOLOGICAL).

Who is sponsoring clinical trial NCT05714202?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05714202 being conducted?

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

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.