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

ACTIVE NOT RECRUITING 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)

NCT05714202 · View on ClinicalTrials.gov ↗

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

442 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05714202

The ClinicalTrials.gov registry entry for NCT05714202 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,135 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05714202 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05714202?

The interventions under investigation include: TAR-200 (DRUG), Cetrelimab (BIOLOGICAL), BCG Vesiculture (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05714202?

This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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