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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 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 212-participant average among 28 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (181% higher). The trial reports 20 study locations across 7 states.

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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.

Conditions Studied

Non-muscle Invasive Bladder Cancer

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

FieldValue
Enrollment Target 596 participants
Start Date 2014-07-21
Est. Completion 2038-12
Phase Phase 1

Sponsor

ImmunityBio

46 total trials

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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, categorized as Phase 1. The registered enrollment target is 596 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 212-participant average among 28 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (181% higher). The listed sponsor is ImmunityBio, which has 46 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.