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

NCT03022825Phase 2/3Active, not recruiting

Lead sponsor
ImmunityBio, Inc. (Industry)
Enrollment
190 (actual)
Start date
2 Jun 2017
Primary completion
1 Oct 2024 (actual)
Study completion
1 Mar 2029
Last update posted
16 Oct 2025

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None
Arms
1

Interventions

  • N-803 and BCG Drug
  • N-803 Drug

Conditions and primary outcome

  • Bladder Cancer

Primary outcome

Complete Response (60 Months); Disease-Free Rate (12 Months)

Posted results on ClinicalTrials.gov

Results posted on ClinicalTrials.gov: No

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

2 on PubMed
  1. Prolonged Progression-Free Survival, Disease-Free Survival, and Cystectomy Avoidance With IL-15 Receptor Lymphocyte-Stimulating Agent NAI Plus Bacillus Calmette-Guérin in Bacillus Calmette-Guérin-Unresponsive Papillary-Only Nonmuscle-Invasive Bladder Cancer.

    The Journal of urology · 2026 Jan

  2. N-803 Plus BCG Treatment for BCG-Naïve or -Unresponsive Non-Muscle Invasive Bladder Cancer: A Plain Language Review.

    Future oncology (London, England) · 2024

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

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Data integrity

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Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

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