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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

NCT03022825•ImmunityBio, Inc.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female patients 18 years of age or older
•Histologic confirmation of non-muscle invasive bladder cancer of the transitional cell carcinoma high-grade subtype (mixed histology tumors allowed if transitional cell histology is predominant histology).
•Histologically confirmed presence of BCG-unresponsive CIS (with or without Ta or T1 disease) or histologically confirmed presence of BCG-unresponsive high-grade Ta or T1 disease.
•Absence of resectable disease after transurethral resection (TURBT) procedures (residual carcinoma in situ (CIS) acceptable; patients with T1 tumors must undergo repeat resection and biopsy \[inclusive of muscularis propria\] if initial biopsy did not include muscularis propria). Patients with high-grade Ta and/or T1 disease should have complete resection before study treatment.
•BCG-unresponsive disease as defined as: (a) Persistent or recurrent CIS (+/- recurrent Ta/T1 disease) within 12 months of receiving adequate BCG (at least five of six doses doses of an initial induction course plus either at least two of three doses of maintenance therapy or at least two of six doses of a second induction course); or (b) Recurrent high-grade Ta/T1 disease within 6 months of completion of adequate BCG (at least five of six doses of an initial induction course plus either at least two of three doses of maintenance therapy or at least two of six doses of a second induction course); or (c) T1 high-grade disease at the first evaluation following an induction BCG course alone (at least five of six doses of an initial induction course).
•Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
•Voluntary written informed consent and HIPAA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations

Exclusion Criteria

•Recurrence of BCG unresponsive Ta/T1 disease (without presence of CIS) \> 6 months after last BCG instillation or BCG unresponsive CIS \> 12 months after last BCG instillation.
•Life expectancy \<2 years
•Any of the following clinical laboratory values at the time of enrollment: (1) Absolute neutrophil count (ANC) \<800/µL or (2) Platelets \< 50,000/µL
•Liver function abnormalities as indicated by ongoing hepatic enzyme elevation (AST or ALT) \>2 times upper limit of normal (ULN)
•Renal insufficiency as indicated by a creatinine level \>3 times ULN
•History of or evidence of muscle-invasive, locally advanced, metastatic and/or extravesical bladder cancer (inclusive of the prostatic urethra); or any other cancer within the past 5 years that is progressing or requires active treatment. Exceptions are adequately treated basal cell or squamous cell skin cancer that has undergone potentially curative therapy or in situ cervical cancer; and adequately treated stage I or II cancer or stable prostate cancer from which the patient is currently in complete remission, and is under active surveillance or hormone control.
•Symptomatic congestive heart failure (CHF), New York Heart Association (NYHA) Class III or IV heart failure or other clinical signs of severe cardiac dysfunction
•Severe/unstable angina pectoris, or myocardial infarction within 6 months prior to study entry
•History or evidence of uncontrollable central nervous system (CNS) disease
•Active systemic infection requiring parenteral antibiotic therapy. All prior infections must have resolved following optimal therapy
+6 more criteria

Locations (28)

Alaska Clinical Research Center

Anchorage, Alaska, United States

Arkansas Urology

Little Rock, Arkansas, United States

UCLA Department of Urology

Los Angeles, California, United States

Hoag Memorial Hospital

Newport Beach, California, United States

Skyline Urology

Sherman Oaks, California, United States

Skyline Urology

Torrance, California, United States

Urology Associates, PC

Englewood, Colorado, United States

University of Miami Miller School of Medicine-Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Clinical Research Center of Florida

Pompano Beach, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Key Dates

Start Date

June 2, 2017

Primary Completion Date

October 1, 2024

Completion Date

March 1, 2029

Last Updated

October 16, 2025

Enrollment

190

ACTUAL participants

Conditions

Bladder Cancer

Interventions

N-803 and BCG

DRUG

N-803

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Testing Olaparib in Patients With Advanced or Metastatic (Cancer That Has Spread) Bladder Cancer and Other Genitourinary Tumors With DNA-Repair Genetic Changes

Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial

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En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device

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