Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING 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

NCT04658862 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 518 participants
Start Date 2020-12-07
Est. Completion 2028-12-31
Phase Phase 3

Sponsor

Janssen Research & Development

442 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04658862

The ClinicalTrials.gov registry entry for NCT04658862 describes a study currently listed as active not recruiting. It is categorized as Phase 3, 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 518 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 5 interventions — of which Cisplatin 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: NCT04658862 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, North Carolina. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04658862?

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 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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial