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NCT04919512 · ClinicalTrials.gov registry record · Phase 2
A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder
A Phase 2 study of Urinary Bladder Neoplasms, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 2
- Development phase
- 163
- Enrollment target
- 20
- Study locations
NCT04919512: Active Phase 2 study of Urinary Bladder Neoplasms, sponsored by Janssen Research & Development.
NCT04919512 is a Phase 2 study of Urinary Bladder Neoplasms that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 163 participants, below the 304-participant average among 19 other Urinary Bladder Neoplasms trials with a reported enrollment target (46% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04919512, a Phase 2 study of Urinary Bladder Neoplasms, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 163 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the anti-tumor effects of TAR-200 in combination with intravenous (IV) cetrelimab and IV cetrelimab alone.
Primary Outcome
pCR was defined as percentage of participants who achieved complete pathologic response. Complete pathologic response is defined as ypT0N0 (no evidence of disease) as assessed by pathologic evaluation on radical cystectomy (RC) specimen. pCR was determined by central pathologic review.
Conditions Studied
Interventions
- DRUG TAR-200
- BIOLOGICAL Cetrelimab
Study Locations (20)
Florida
- University of Florida Health Jacksonville - Jacksonville
- Mayo Clinic - Jacksonville
- Baptist Hospital of Miami - Miami
Arkansas
- UAMS Winthrop P. Rockefeller Cancer Institute - Little Rock
- Arkansas Urology - Little Rock
California
- City of Hope - Duarte
- Genesis Research - San Diego
Indiana
- Urology of Indiana - Indianapolis
- First Urology - Jeffersonville
Maryland
- University Of Maryland Medical Center - Baltimore
- Penn Medicine - PerelmanCenter for Advanced Medicine - Baltimore
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- Urological Associates of Southern Arizona, P.C. - Tucson
Colorado
- Colorodo Urology- St. Anthony Hospital - Golden
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 163 participants |
| Start Date | 2022-07-07 |
| Est. Completion | 2027-03-07 |
| Phase | Phase 2 |
What the registry record for NCT04919512 still lists
NCT04919512 is an interventional study that assigns participants to a tested intervention. The registered 163 participants enrollment target is mid-sized for trials with a published cap, below the 304-participant average among 19 other Urinary Bladder Neoplasms trials with a reported enrollment target (46% lower).
The record links to 1 condition, with Urinary Bladder Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which TAR-200 is the first listed.
NCT04919512 names 20 study sites across 14 states, led by Florida, Arkansas, California.
Frequently Asked Questions
What is clinical trial NCT04919512 about?
NCT04919512 is a clinical study titled "A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder". The purpose of this study is to evaluate the anti-tumor effects of TAR-200 in combination with intravenous (IV) cetrelimab and IV cetrelimab alone.
What is the current status of trial NCT04919512?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 163 participants. The study started on 2022-07-07. Estimated completion is 2027-03-07.
What conditions does trial NCT04919512 study?
This clinical trial studies the following conditions: Urinary Bladder Neoplasms.
What interventions are being tested in trial NCT04919512?
The interventions under investigation include: TAR-200 (DRUG), Cetrelimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04919512?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04919512 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04919512's enrollment target sits among peer trials
163 12th of 19 higher than 8 of 19 other Urinary Bladder Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urinary Bladder Neoplasms 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.
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