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

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.

View on ClinicalTrials.gov ↗

View your shortlist →

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

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

4 total trials

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.

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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT03125655 · 13 participants

    Regulation of Inflammatory Genes in Psoriasis

  • NCT03774446 · 13 participants · Phase 2

    Multicenter Study of Seliciclib (R-roscovitine) for Cushing Disease

  • NCT03830151 · 13 participants · Phase 1

    Hyperpolarized Carbon C 13 Pyruvate in Diagnosing Glioma in Patients With Brain Tumors

  • NCT04573231 · 13 participants · Phase 2

    Evaluation of PSMA in HER2- AR+ Metastatic Breast Cancer

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT03518320, the US trial registry maintained by the National Library of Medicine. NCT03518320 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.