Safety and Tolerability of TAR-200 and Nivolumab in Subjects With Muscle-Invasive Bladder Cancer
Public ClinicalTrials.gov record NCT03518320. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Study identification
- NCT ID
- NCT03518320
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1
- Lead sponsor
- Taris Biomedical LLC
- Industry
- Enrollment
- 13 participants
Conditions and interventions
Conditions
- Bladder Cancer TNM Staging Distant Metastasis (M) M0
- 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
Interventions
- Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200 Drug
- Nivolumab Injection [Opdivo] Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 1, 2019
- Primary completion
- Dec 10, 2019
- Completion
- Dec 10, 2019
- Last update posted
- Aug 26, 2024
2019
United States locations
- U.S. sites
- 6
- U.S. states
- 6
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| DuPage Medical Group | Hinsdale | Illinois | 60521 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| The University of Oklahoma Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03518320, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 26, 2024 · Synced May 12, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03518320 live on ClinicalTrials.gov.