Trials / Terminated
TerminatedNCT03518320
Safety and Tolerability of TAR-200 and Nivolumab in Subjects With Muscle-Invasive Bladder Cancer
A Multicenter Study of TAR-200 in Combination With Nivolumab (OPDIVO) in Subjects With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Scheduled for Radical Cystectomy and Are Ineligible for or Refusing Platinum-Based Neoadjuvant Chemotherapy
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Taris Biomedical LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Bladder Cancer TNM Staging Primary Tumor (T) T2
- Bladder Cancer TNM Staging Primary Tumor (T) T2A
- Bladder Cancer TNM Staging Primary Tumor (T) T2B
- Bladder Cancer TNM Staging Primary Tumor (T) T3
- Bladder Cancer TNM Staging Primary Tumor (T) T3A
- Bladder Cancer TNM Staging Primary Tumor (T) T3B
- Bladder Cancer TNM Staging Regional Lymph Node (N) N0
- Bladder Cancer TNM Staging Regional Lymph Node (N) N1
- Bladder Cancer TNM Staging Distant Metastasis (M) M0
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200 | TAR-200 will be placed in the bladder through an inserter and gradually release gemcitabine for four consecutive 21-day dosing cycles for a total period of approximately 84 days |
| DRUG | Nivolumab Injection [Opdivo] | Nivolumab will be given intravenously on specified days for four consecutive 21-day dosing cycles for a total period of approximately 84 days |
Timeline
- Start date
- 2019-01-02
- Primary completion
- 2019-12-11
- Completion
- 2019-12-11
- First posted
- 2018-05-08
- Last updated
- 2024-08-27
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03518320. Inclusion in this directory is not an endorsement.