Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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

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. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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).

Primary Outcome

EFS is defined as the time from randomization to either the time of the first recurrence of high-risk disease, progression, or death due to any cause, whichever occurs first. For participants with carcinoma In-situ (CIS), persistent disease at 6 months (Week 24) is also considered an EFS event. Progression is defined as: an increase of stage from Ta to T1 or from CIS to T1 or progression to muscle invasive bladder cancer (MIBC) (T greater than or equal to \[\>=\] 2) or to lymph node (N+) or to d

Conditions Studied

Bladder Cancer

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
Janssen Research & Development

593 total trials

What the registry record for NCT05714202 still lists

NCT05714202 is an interventional study that assigns participants to a tested intervention. Its 1,135 participants enrollment target places it among the larger protocols in the corpus, below the 12,747-participant average among 175 other Bladder Cancer trials with a reported enrollment target (91% lower).

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 names 20 study sites across 8 states, led by 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.

Learn More About Clinical Trials

Similar trials for Bladder Cancer

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 NCT05714202's enrollment target sits among peer trials

1,135 13th of 175 higher than 163 of 175 other Bladder Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Bladder Cancer 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT05894967 · 1,140 participants · NA

    Moderators and Mediators of Perceptual Learning

  • NCT06532487 · 1,140 participants · NA

    Addressing Durable Health Disparities Through Critical Time Legal Interventions in Medically Underserved Latinx and Migrant Communities

  • NCT06445062 · 1,130 participants · Phase 1

    Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors

  • NCT06746129 · 1,126 participants · Phase 3

    Cleavage-stage Versus Blastocyst-stage Embryo Transfer in IVF Patients With Few Embryos

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Related registry views

Source: ClinicalTrials.gov NCT05714202, the US trial registry maintained by the National Library of Medicine. NCT05714202 (large enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.