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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2019-01-02 |
| Est. Completion | 2019-12-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗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.
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