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NCT03518320 · ClinicalTrials.gov registry record · Phase 1

Safety and Tolerability of TAR-200 and Nivolumab in Subjects With Muscle-Invasive Bladder Cancer

A Phase 1 study, sponsored by Taris Biomedical.

Terminated
Registry status
Phase 1
Development phase
13
Enrollment target

NCT03518320 is a Phase 1 study that was terminated before completion, run by Taris Biomedical. The registered enrollment target is 13 participants.

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The verdict

NCT03518320, a Phase 1 study, was terminated before completion, sponsored by Taris Biomedical.

TERMINATED
Registry status
Phase 1
Development phase
13 participants
Enrollment target

Study Summary

The purpose of this study is to determine if TAR-200, an investigational drug delivery system, in combination with nivolumab is safe and tolerable in patients with muscle-invasive bladder cancer (MIBC) who are scheduled for radical cystectomy (RC) during an 84-day dosing cycle induction period comprised of four consecutive 21-day dosing cycles.

Interventions

  • DRUG Nivolumab Injection [Opdivo]
  • DRUG Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2019-01-02
Est. Completion 2019-12-11
Phase Phase 1

Sponsor

Taris Biomedical

4 total trials

What the Registry Record Tells You About NCT03518320

The ClinicalTrials.gov registry entry for NCT03518320 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Taris Biomedical, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Nivolumab Injection [Opdivo] is the first listed.

NCT03518320 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03518320 about?

NCT03518320 is a clinical study titled "Safety and Tolerability of TAR-200 and Nivolumab in Subjects With Muscle-Invasive Bladder Cancer". The purpose of this study is to determine if TAR-200, an investigational drug delivery system, in combination with nivolumab is safe and tolerable in patients with muscle-invasive bladder cancer (MIBC) who are scheduled for radical cystectomy (RC) during an 84-day dosing cycle induction period compr...

What is the current status of trial NCT03518320?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2019-01-02. Estimated completion is 2019-12-11.

What interventions are being tested in trial NCT03518320?

The interventions under investigation include: Nivolumab Injection [Opdivo] (DRUG), Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200 (DRUG).

Who is sponsoring clinical trial NCT03518320?

This trial is sponsored by Taris Biomedical, which has 4 total clinical trials registered on ClinicalTrials.gov.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.