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NCT02138734 · ClinicalTrials.gov registry record · Phase 1
A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer
A Phase 1 study of Non-muscle Invasive Bladder Cancer, sponsored by ImmunityBio.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 596
- Enrollment target
- 20
- Study locations
NCT02138734: Recruiting Phase 1 study of Non-muscle Invasive Bladder Cancer, sponsored by ImmunityBio.
NCT02138734 is a Phase 1 study of Non-muscle Invasive Bladder Cancer that is actively recruiting participants, run by ImmunityBio. The registered enrollment target is 596 participants, above the 207-participant average among 30 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (188% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02138734, a Phase 1 study of Non-muscle Invasive Bladder Cancer, is actively recruiting participants, sponsored by ImmunityBio.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 596 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase Ib/IIb, randomized, two-cohort, open-label, multicenter study of intravesical N-803 plus BCG versus BCG alone, in BCG naïve patients with high-grade NMIBC.
Primary Outcome
Patients in Cohort A: compare complete response rate between treatment arms using cystoscopy, confirmatory bladder biopsy and urine cytology.
Conditions Studied
Interventions
- BIOLOGICAL BCG+N-803( 50mg BCG/ Instillation+ N-803( 400 μg/instillation). )
- BIOLOGICAL BCG( 50mg/Instillation)
Study Locations (20)
California
- Hoag Memorial Hospital Presbyterian - Irvine
- University of Southern California - Los Angeles
- UCLA Department of Urology - Los Angeles
- University of California, Irvine Medical Center - Orange
- University of California, Davis - Sacramento
- Golden State Urology - Sacramento
- University of California San Diego - San Diego
- Skyline Sherman Oaks - Sherman Oaks
- Skyline Urology - Torrance
Florida
- Memorial Healthcare System - Hollywood
- Mayo Clinic - Jacksonville
- Advanced Urology Institute - Oxford
- Clinical Research Center of Florida - Pompano Beach
- Florida Urology Partners - Riverview
Arizona
- Mayo Clinic - Phoenix
- Center for Neurosciences - Tucson
Alabama
- University of Alabama at Birmingham - Birmingham
Alaska
- Alaska Clinical Research Center - Anchorage
Arkansas
- Arkansas Urology - Little Rock
Connecticut
- Eastern Connecticut Hematology & Oncology Associates - Norwich
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 596 participants |
| Start Date | 2014-07-21 |
| Est. Completion | 2038-12 |
| Phase | Phase 1 |
What NCT02138734 shows while recruiting
NCT02138734 is an interventional study that assigns participants to a tested intervention. The registered 596 participants enrollment target is mid-sized for trials with a published cap, above the 207-participant average among 30 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (188% higher).
The record links to 1 condition, with Non-muscle Invasive Bladder Cancer appearing as the primary indexed condition, and to 2 interventions - of which BCG+N-803( 50mg BCG/ Instillation+ N-803( 400 μg/instillation). ) is the first listed.
NCT02138734 names 20 study sites across 7 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT02138734 about?
NCT02138734 is a clinical study titled "A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer". This is a Phase Ib/IIb, randomized, two-cohort, open-label, multicenter study of intravesical N-803 plus BCG versus BCG alone, in BCG naïve patients with high-grade NMIBC.
What is the current status of trial NCT02138734?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 596 participants. The study started on 2014-07-21. Estimated completion is 2038-12.
What conditions does trial NCT02138734 study?
This clinical trial studies the following conditions: Non-muscle Invasive Bladder Cancer.
What interventions are being tested in trial NCT02138734?
The interventions under investigation include: BCG+N-803( 50mg BCG/ Instillation+ N-803( 400 μg/instillation). ) (BIOLOGICAL), BCG( 50mg/Instillation) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02138734?
This trial is sponsored by ImmunityBio, which has 46 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02138734 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02138734's enrollment target sits among peer trials
596 4th of 30 higher than 27 of 30 other Non-muscle Invasive Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-muscle Invasive 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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