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 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: CA-ALT-803-01-16
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 28

Brief 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.

Conditions

Bladder Cancer

Keywords

BCG; bladder cancer; immunotherapy; interleukin-15; intravesical; non-muscle invasive; NMIBC

Outcome Measures

Primary Outcomes (2)

• Complete Response

  Cohort A \& Cohort C: Assess incidence of complete response of CIS (with or without Ta/T1 papillary disease) patients at any time

  60 Months

• Disease-Free Rate

  Cohort B: Assess disease-free rate at 12 months since first study treatment

  12 Months

Secondary Outcomes (7)

• Response

  60 months

• Response

  6 months

• Response

  9 months

• Response

  12 months

• Response

  18 months

Study Arms (1)

BCG+N-803

EXPERIMENTAL

Drug: N-803 and BCG; Drug: N-803

Interventions

N-803 and BCG DRUG

BCG and N-803 will be mixed together (with saline) and administered via intravesical instillation weekly for 6 consecutive weeks (induction). 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.

BCG+N-803

N-803 DRUG

N-803 will be administered via intravesical instillation weekly for 6 consecutive weeks (induction). 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.

BCG+N-803

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Concurrent febrile illness, active urinary tract infection, active tuberculosis, a history of hypotension or anaphylactic reactions
• Ongoing chronic systemic steroid therapy required (\>10 mg oral prednisone daily or equivalent)
• Women who are pregnant or nursing. Female patients of childbearing potential must have a negative pregnancy test and must adhere to using a medically acceptable method of birth control prior to screening and agree to continue its use during the study and for 30 days after the last dose of study drug, or be surgically sterilized (e.g., hysterectomy or tubal ligation). Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Males must agree to use barrier methods of birth control while on study and for 90 days post last dose of study drug.
• Patients currently receiving investigational or commercial anti-cancer agents or anti-cancer therapies other than BCG, ALT-803 and supportive care therapies for active disease.
• Concurrent use of other investigational agents (not including FDA authorized drugs for the prevention and treatment of COVID-19).

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

Study Sites (28)

Alaska Clinical Research Center

Anchorage, Alaska, 99503, United States

Location

Arkansas Urology

Little Rock, Arkansas, 72211, United States

Location

UCLA Department of Urology

Los Angeles, California, 90024, United States

Location

Hoag Memorial Hospital

Newport Beach, California, 92663, United States

Location

Skyline Urology

Sherman Oaks, California, 91411, United States

Location

Skyline Urology

Torrance, California, 90505, United States

Location

Urology Associates, PC

Englewood, Colorado, 80113, United States

Location

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

Miami, Florida, 33136, United States

Location

Clinical Research Center of Florida

Pompano Beach, Florida, 33060, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Dwight D. Eisenhower Army Medical Center

Augusta, Georgia, 30905, United States

Location

University of Hawaii Cancer Center

Honolulu, Hawaii, 96814, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Adult & Pediatric Urology

Omaha, Nebraska, 68114, United States

Location

Accument Rx

Albuquerque, New Mexico, 87109, United States

Location

Roswell Park Cancer Insitute

Buffalo, New York, 14263, United States

Location

Winthrop University Hospital Department of Urology

Garden City, New York, 11530, United States

Location

Integrated Medical Professionals

New York, New York, 10016, United States

Location

Premier Medical Group of the Hudson Valley

Poughkeepsie, New York, 12601, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Associated Urologists of North Carolina

Raleigh, North Carolina, 27612, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Virginia Urology

Richmond, Virginia, 23235, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

Related Publications (2)

• Chang SS, Chamie K, Kramolowsky E, Gonzalgo ML, Agarwal PK, Bassett JC, Bjurlin M, Cher ML, Clark W, Cowan BE, David R, Goldfischer E, Guru K, Jalkut MW, Kaffenberger SD, Kaminetsky J, Corcoran A, Koo AS, Sexton WJ, Tikhonenkov SN, Shah MS, Trabulsi EJ, Trainer AF, Spilman P, Huang M, Bhar P, Drusbosky LM, Sender L, Brown B, Reddy S, Soon-Shiong P. Prolonged Progression-Free Survival, Disease-Free Survival, and Cystectomy Avoidance With IL-15 Receptor Lymphocyte-Stimulating Agent NAI Plus Bacillus Calmette-Guerin in Bacillus Calmette-Guerin-Unresponsive Papillary-Only Nonmuscle-Invasive Bladder Cancer. J Urol. 2026 Jan;215(1):44-56. doi: 10.1097/JU.0000000000004782. Epub 2025 Sep 16.

  PMID: 40956664 DERIVED

• Chamie K, Chang SS, Rosser CJ, Kramolowski E, Gonzalgo ML, Sexton WJ, Spilman P, Sender L, Reddy S, Soon-Shiong P. N-803 Plus BCG Treatment for BCG-Naive or -Unresponsive Non-Muscle Invasive Bladder Cancer: A Plain Language Review. Future Oncol. 2024;20(31):2307-2317. doi: 10.1080/14796694.2024.2363744. Epub 2024 Jul 2.

  PMID: 38953850 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms

Interventions

ALT-803

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Karim Chamie, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: January 18, 2017
• Study Start: June 2, 2017
• Primary Completion: October 1, 2024
• Study Completion (Estimated): March 1, 2029
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (28)