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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 1,135 participants |
| Start Date | 2023-03-23 |
| Est. Completion | 2029-09-18 |
| Phase | Phase 3 |
Interested in This 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, 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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Read our methodology - how this data is sourced, computed, and verified.
Related
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