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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: Active Phase 2 study of Bladder Cancer, sponsored by ImmunityBio.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Cohort A \& Cohort C: Assess incidence of complete response of CIS (with or without Ta/T1 papillary disease) patients at any time
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 |
What the registry record for NCT03022825 still lists
NCT03022825 is an interventional study that assigns participants to a tested intervention. The registered 190 participants enrollment target is mid-sized for trials with a published cap, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (99% lower).
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 names 20 study sites across 12 states, led by 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03022825's enrollment target sits among peer trials
190 60th of 175 higher than 116 of 175 other Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bladder Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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