ADSTILADRIN (=INSTILADRIN) in Patients With High-Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)
Public ClinicalTrials.gov record NCT02773849. 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 Phase III, Open Label Study to Evaluate the Safety and Efficacy of INSTILADRIN® (rAd-IFN)/Syn3) Administered Intravesically to Patients With High-Grade, BCG Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Previous multi-dose Phase I and Phase II clinical studies have demonstrated that ADSTILADRIN is a safe and effective treatment for BCG-refractory and recurrent NMIBC. This Phase III study is designed to expand those observations using a high dose of ADSTILADRIN in patients that are "BCG Unresponsive" which refers to patients with high-grade NMIBC who are unlikely to benefit from and should not receive further intravesical BCG.
Study identification
- NCT ID
- NCT02773849
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 157 participants
Conditions and interventions
Conditions
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
- Sep 19, 2016 (Actual)
- Primary completion
- May 24, 2019 (Actual)
- Completion
- May 24, 2023 (Actual)
- Last update posted
- Jul 29, 2024
2016 – 2023
United States locations
- U.S. sites
- 34
- U.S. states
- 22
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | — |
| Keck School of Medicine at USC Medical Center | Los Angeles | California | 90089 | — |
| The Urology Center of Colorado | Denver | Colorado | 80211 | — |
| University of Florida - UF Health Davis Center Pavilion and Shands Med Plaza | Gainesville | Florida | 32610 | — |
| H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | — |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | — |
| University of Chicago - Comprehensive Cancer Research Center | Chicago | Illinois | 60637 | — |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | — |
| Johns Hopkins Kimmel Cancer Center | Baltimore | Maryland | 21287 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Spectrum Health Medical Group | Grand Rapids | Michigan | 49546 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Delaware Valley Urology, LLC | Voorhees Township | New Jersey | 08043 | — |
| SUNY Upstate Medical Center | Syracuse | New York | 13210 | — |
| Montefiore Medical Center | The Bronx | New York | 10461 | — |
| University of North Carolina (UNC) - Chapel Hill | Chapel Hill | North Carolina | 27599-7235 | — |
| Duke University | Durham | North Carolina | 27710 | — |
| The University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| The Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Regional Urology | Greenville | South Carolina | 29605 | — |
| Carolina Urologic research Center | Myrtle Beach | South Carolina | 29572 | — |
| Vanderbilt University Medical Center Dept. of Urologic Surgery | Nashville | Tennessee | 37232 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| The Univ. of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229-3900 | — |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | — |
| Urology of Virginia | Virginia Beach | Virginia | 23462 | — |
| West Virginia University Cancer Institute | Morgantown | West Virginia | 26506 | — |
| University of Wisconsin - Madison | Madison | Wisconsin | 53705 | — |
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 NCT02773849, 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 Jul 29, 2024 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02773849 live on ClinicalTrials.gov.