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NCT04658862 · ClinicalTrials.gov registry record · Phase 3
A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder
A Phase 3 study of Urinary Bladder Neoplasms, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 3
- Development phase
- 518
- Enrollment target
- 20
- Study locations
NCT04658862: Active Phase 3 study of Urinary Bladder Neoplasms, sponsored by Janssen Research & Development.
NCT04658862 is a Phase 3 study of Urinary Bladder Neoplasms that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 518 participants, above the 286-participant average among 19 other Urinary Bladder Neoplasms trials with a reported enrollment target (81% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04658862, a Phase 3 study of Urinary Bladder Neoplasms, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 518 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of study is to compare bladder intact-event free survival (BI-EFS) in participants receiving TAR-200 in combination with intravenous (IV) cetrelimab versus concurrent chemoradiotherapy.
Primary Outcome
Time from randomization to the first BI-EFS event includes histologically proven presence of muscle-invasive bladder cancer (MIBC), clinical evidence of nodal or metastatic disease (as assessed by RECIST 1.1 criteria), radical cystectomy (RC), or death due to any cause.
Conditions Studied
Interventions
- DRUG Cisplatin
- DRUG Gemcitabine
- DRUG TAR-200
- BIOLOGICAL Cetrelimab
- RADIATION Conventional radiation therapy
Study Locations (20)
California
- Loma Linda Univ Faculty Medic - Loma Linda
- University of Southern California - Los Angeles
- Providence Saint John s Health Center - Santa Monica
- Stanford University Medical Center - Stanford
Florida
- Boca Raton Regional Hospital - Boca Raton
- Urological Research Network - Hialeah
- Memorial Healthcare System - Pembroke Pines
North Carolina
- Duke University Medical Center - Durham
- Vidant Urology - Greenville - Greenville
- Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center - Winston-Salem
Colorado
- The Urology Center of Colorado - Denver
- Foothills Urology - Golden Off - Golden
Michigan
- University Hospitals Seidman Cancer Center - Ann Arbor
- Michigan Institute of Urology - Troy
New Jersey
- Garden State Urology - Morristown
- New Jersey Urology LLC - Voorhees Township
Georgia
- Winship Cancer Institute of Emory University - Atlanta
Illinois
- DuPage Medical Group - Lisle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 518 participants |
| Start Date | 2020-12-07 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 3 |
What the registry record for NCT04658862 still lists
NCT04658862 is an interventional study that assigns participants to a tested intervention. The registered 518 participants enrollment target is mid-sized for trials with a published cap, above the 286-participant average among 19 other Urinary Bladder Neoplasms trials with a reported enrollment target (81% higher).
The record links to 1 condition, with Urinary Bladder Neoplasms appearing as the primary indexed condition, and to 5 interventions - of which Cisplatin is the first listed.
NCT04658862 names 20 study sites across 10 states, led by California, Florida, North Carolina.
Frequently Asked Questions
What is clinical trial NCT04658862 about?
NCT04658862 is a clinical study titled "A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder". The purpose of study is to compare bladder intact-event free survival (BI-EFS) in participants receiving TAR-200 in combination with intravenous (IV) cetrelimab versus concurrent chemoradiotherapy.
What is the current status of trial NCT04658862?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 518 participants. The study started on 2020-12-07. Estimated completion is 2028-12-31.
What conditions does trial NCT04658862 study?
This clinical trial studies the following conditions: Urinary Bladder Neoplasms.
What interventions are being tested in trial NCT04658862?
The interventions under investigation include: Cisplatin (DRUG), Gemcitabine (DRUG), TAR-200 (DRUG), Cetrelimab (BIOLOGICAL), Conventional radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT04658862?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04658862 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04658862's enrollment target sits among peer trials
518 5th of 19 higher than 15 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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