QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer
Public ClinicalTrials.gov record NCT03022825. 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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase II/III, open-label, single-arm, multicenter study of intravesical BCG plus N-803 or N-803 only in patients with BCG unresponsive high grade non-muscle invasive bladder cancer (NMIBC). All patients treated in the study will receive via a urinary catheter in the bladder, BCG plus N-803 or N-803 only weekly for 6 consecutive weeks (initial induction treatment period). After the first disease assessment, eligible patients will receive either a 3-week maintenance course or a 6-week re-induction course (second treatment period) at Month 3. Eligible patients will continue to receive maintenance treatment in the third treatment period at Months 6, 9, 12, and 18. Eligible patients have the option to receive maintenance treatment in the fourth treatment period at Months 24, 30, and 36. The study duration is 60 months.
Study identification
- NCT ID
- NCT03022825
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 190 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
- Jun 2, 2017 (Actual)
- Primary completion
- Oct 1, 2024 (Actual)
- Completion
- Mar 1, 2029 (Estimated)
- Last update posted
- Oct 16, 2025
2017 – 2029
United States locations
- U.S. sites
- 28
- U.S. states
- 17
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alaska Clinical Research Center | Anchorage | Alaska | 99503 | — |
| Arkansas Urology | Little Rock | Arkansas | 72211 | — |
| UCLA Department of Urology | Los Angeles | California | 90024 | — |
| Hoag Memorial Hospital | Newport Beach | California | 92663 | — |
| Skyline Urology | Sherman Oaks | California | 91411 | — |
| Skyline Urology | Torrance | California | 90505 | — |
| Urology Associates, PC | Englewood | Colorado | 80113 | — |
| University of Miami Miller School of Medicine-Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | — |
| Clinical Research Center of Florida | Pompano Beach | Florida | 33060 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| Dwight D. Eisenhower Army Medical Center | Augusta | Georgia | 30905 | — |
| University of Hawaii Cancer Center | Honolulu | Hawaii | 96814 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Adult & Pediatric Urology | Omaha | Nebraska | 68114 | — |
| Accument Rx | Albuquerque | New Mexico | 87109 | — |
| Roswell Park Cancer Insitute | Buffalo | New York | 14263 | — |
| Winthrop University Hospital Department of Urology | Garden City | New York | 11530 | — |
| Integrated Medical Professionals | New York | New York | 10016 | — |
| Premier Medical Group of the Hudson Valley | Poughkeepsie | New York | 12601 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| UNC Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Associated Urologists of North Carolina | Raleigh | North Carolina | 27612 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Virginia Urology | Richmond | Virginia | 23235 | — |
| Madigan Army Medical Center | Tacoma | Washington | 98431 | — |
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 NCT03022825, 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 Oct 16, 2025 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03022825 live on ClinicalTrials.gov.