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NCT03022825 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Bladder Cancer, sponsored by ImmunityBio.
- Active
- Registry status
- Phase 2
- Development phase
- 190
- Enrollment target
- 20
- Study locations
NCT03022825 is a Phase 2 study of Bladder Cancer that is active but no longer recruiting, run by ImmunityBio. The registered enrollment target is 190 participants, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT03022825, a Phase 2 study of Bladder Cancer, is active but no longer recruiting, sponsored by ImmunityBio.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 190 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG N-803
- DRUG N-803 and BCG
Study Locations (20)
California
- UCLA Department of Urology - Los Angeles
- Hoag Memorial Hospital - Newport Beach
- Skyline Urology - Sherman Oaks
- Skyline Urology - Torrance
Florida
- University of Miami Miller School of Medicine-Sylvester Comprehensive Cancer Center - Miami
- Clinical Research Center of Florida - Pompano Beach
- Moffitt Cancer Center - Tampa
New York
- Roswell Park Cancer Insitute - Buffalo
- Winthrop University Hospital Department of Urology - Garden City
- Integrated Medical Professionals - New York
Michigan
- University of Michigan - Ann Arbor
- Karmanos Cancer Institute - Detroit
Alaska
- Alaska Clinical Research Center - Anchorage
Arkansas
- Arkansas Urology - Little Rock
Colorado
- Urology Associates, PC - Englewood
Georgia
- Dwight D. Eisenhower Army Medical Center - Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2017-06-02 |
| Est. Completion | 2029-03-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03022825
The ClinicalTrials.gov registry entry for NCT03022825 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 190 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (99% lower). The listed sponsor is ImmunityBio, which has 46 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Bladder Cancer appearing as the primary indexed condition, and to 2 interventions - of which N-803 is the first listed.
NCT03022825 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Florida, New York.
Frequently Asked Questions
What is clinical trial NCT03022825 about?
NCT03022825 is a clinical study titled "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". 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...
What is the current status of trial NCT03022825?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 190 participants. The study started on 2017-06-02. Estimated completion is 2029-03-01.
What conditions does trial NCT03022825 study?
This clinical trial studies the following conditions: Bladder Cancer.
What interventions are being tested in trial NCT03022825?
The interventions under investigation include: N-803 (DRUG), N-803 and BCG (DRUG).
Who is sponsoring clinical trial NCT03022825?
This trial is sponsored by ImmunityBio, which has 46 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03022825 being conducted?
This trial has 20 study locations across Alaska, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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