drugset / Trial / NCT03518320
Safety and Tolerability of TAR-200 and Nivolumab in Subjects With Muscle-Invasive Bladder Cancer
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2019-01-02
- Primary completion
- 2019-12-11
- Completion
- 2019-12-11
Outcome
Outcome not reported
Stopped (Business): “Business objectives have changed”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | — | Other |
| Subject | Nivolumab | Monoclonal antibody | — | Intravenous |