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NCT04640623 · ClinicalTrials.gov registry record · Phase 2
A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy
A Phase 2 study of Urinary Bladder Neoplasms, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 2
- Development phase
- 220
- Enrollment target
- 20
- Study locations
NCT04640623: Active Phase 2 study of Urinary Bladder Neoplasms, sponsored by Janssen Research & Development.
NCT04640623 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 220 participants, below the 301-participant average among 19 other Urinary Bladder Neoplasms trials with a reported enrollment target (27% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04640623, 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
- 220 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the overall complete response (CR) rate in participants treated with TAR-200 in combination with cetrelimab (Cohort 1), or TAR-200 alone (Cohort 2), or cetrelimab alone (Cohort 3) with Carcinoma in Situ (CIS), with or without concomitant high-grade Ta or T1 papillary disease; and disease-free survival (DFS) in participants treated with TAR-200 alone with papillary disease only (Cohort 4).
Primary Outcome
Overall CR rate was defined as the percentage of participants who met at least one of the following: negative cystoscopy and negative (including atypical) centrally read urine cytology, or positive cystoscopy with biopsy-proven benign or low-grade non-muscle invasive bladder cancer (NMIBC) and negative (including atypical) centrally read cytology at any time point.
Conditions Studied
Interventions
- DRUG TAR-200
- BIOLOGICAL Cetrelimab
Study Locations (20)
New York
- NYU Langone Health - New York
- SUNY Upstate Medical University - Syracuse
- Associated Medical Professionals - Syracuse
California
- University of Southern California - Los Angeles
- Genesis Healthcare Partners - Genesis Research Greater Los Angeles - Sherman Oaks
Colorado
- The Urology Center of Colorado - Denver
- Foothills Urology - Golden Off - Golden
Pennsylvania
- Urologic Consultants of Southeastern Pennsylvania - Bala-Cynwyd
- Thomas Jefferson University - Philadelphia
Tennessee
- Urology Associates, PC - Nashville
- Vanderbilt University Medical Center - Nashville
Texas
- Urology Austin - Austin
- University of Texas Southwestern Medical Center - Dallas
Arizona
- Del Sol Research Management, LLC - Tucson
Illinois
- DuPage Medical Group - Lisle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2020-12-18 |
| Est. Completion | 2027-09-30 |
| Phase | Phase 2 |
What the registry record for NCT04640623 still lists
NCT04640623 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, below the 301-participant average among 19 other Urinary Bladder Neoplasms trials with a reported enrollment target (27% 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.
NCT04640623 names 20 study sites across 13 states, led by New York, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT04640623 about?
NCT04640623 is a clinical study titled "A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy". The purpose of this study is to evaluate the overall complete response (CR) rate in participants treated with TAR-200 in combination with cetrelimab (Cohort 1), or TAR-200 alone (Cohort 2), or cetrelimab alone (Cohort 3) with Carcinoma in Situ (CIS), with or without concomitant high-grade Ta or T1 p...
What is the current status of trial NCT04640623?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 220 participants. The study started on 2020-12-18. Estimated completion is 2027-09-30.
What conditions does trial NCT04640623 study?
This clinical trial studies the following conditions: Urinary Bladder Neoplasms.
What interventions are being tested in trial NCT04640623?
The interventions under investigation include: TAR-200 (DRUG), Cetrelimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04640623?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04640623 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04640623's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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