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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: Clinical Trial Phase 1 study, sponsored by Taris Biomedical.
NCT03518320 is a Phase 1 study that was terminated before completion, run by Taris Biomedical. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Will be assessed through the duration of the study by reported AEs
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 |
Why NCT03518320 stopped before completion
NCT03518320 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Nivolumab Injection [Opdivo] is the first listed.
NCT03518320 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03518320's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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