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A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer
NCT02138734 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02138734
The ClinicalTrials.gov registry entry for NCT02138734 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 596 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ImmunityBio, which has 48 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02138734 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02138734?
This trial is sponsored by ImmunityBio, which has 48 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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