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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
NCT04640623 · View on ClinicalTrials.gov ↗
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04640623
The ClinicalTrials.gov registry entry for NCT04640623 describes a study currently listed as active not recruiting. It is categorized as Phase 2, 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 220 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 Urinary Bladder Neoplasms appearing as the primary indexed condition, and to 2 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: NCT04640623 reports 20 study locations spanning 13 distinct geographic areas — top geographies include New York, California, Colorado. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04640623?
The interventions under investigation include: TAR-200 (DRUG), Cetrelimab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04640623?
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 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.
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