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Bladder CancerPhase 2/3NCT03022825

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

A Phase 2/3 study testing N-803 and BCG and N-803 in people with Bladder Cancer, run by ImmunityBio, Inc. at 28 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer
What is being tested?
N-803 and BCG and N-803
Could I receive a placebo?
No, everyone receives an active treatment
How many people
190 participants
Where
28 sitesUnited States
Study dates
2 Jun 2017to 1 Mar 2029
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 16Show fewer
  • 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).
  • Other illness or condition, including laboratory abnormalities, which in the opinion of the Investigator would exclude the patient from participating in this study. This includes, but is not limited to, serious medical conditions or psychiatric illness likely to interfere with participation in the study.

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

United States28 sites

  • Accument Rx

    Albuquerque, New Mexico, 87109

  • Alaska Clinical Research Center

    Anchorage, Alaska, 99503

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Dwight D. Eisenhower Army Medical Center

    Augusta, Georgia, 30905

  • Roswell Park Cancer Insitute

    Buffalo, New York, 14263

  • UNC Chapel Hill

    Chapel Hill, North Carolina, 27599

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Urology Associates, PC

    Englewood, Colorado, 80113

  • Winthrop University Hospital Department of Urology

    Garden City, New York, 11530

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96814

  • Arkansas Urology

    Little Rock, Arkansas, 72211

  • UCLA Department of Urology

    Los Angeles, California, 90024

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

    Miami, Florida, 33136

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Integrated Medical Professionals

    New York, New York, 10016

  • Hoag Memorial Hospital

    Newport Beach, California, 92663

  • Adult & Pediatric Urology

    Omaha, Nebraska, 68114

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Clinical Research Center of Florida

    Pompano Beach, Florida, 33060

  • Premier Medical Group of the Hudson Valley

    Poughkeepsie, New York, 12601

  • Associated Urologists of North Carolina

    Raleigh, North Carolina, 27612

  • Virginia Urology

    Richmond, Virginia, 23235

  • University of Rochester

    Rochester, New York, 14642

  • Skyline Urology

    Sherman Oaks, California, 91411

  • Madigan Army Medical Center

    Tacoma, Washington, 98431

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Skyline Urology

    Torrance, California, 90505

Other trials in United States

About this study

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
Being tested
N-803 and BCG, N-803
Keywords
BCG, bladder cancer, immunotherapy, interleukin-15, intravesical, non-muscle invasive, NMIBC
Medical subject headings
Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • N-803 and BCGDrug

    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.

  • N-803Drug

    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.

Study groups in NCT03022825
Study groupRoleWhat they receive
BCG+N-803ExperimentalNot described
Receives: Drug: N-803 and BCG; Drug: N-803

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete Response

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

    Measured: 60 Months

  2. Disease-Free Rate

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

    Measured: 12 Months

Secondary outcomes (7)

  1. Response

    Cohort A \& Cohort C: Assess duration of complete response Cohort B: Assess disease-free survival

    Measured: 60 months

  2. Response

    Cohort A \& Cohort C: Assess complete response rate at 6 months. Cohort B: Assess disease-free rate at 6 months

    Measured: 6 months

  3. Response

    Cohort A \& Cohort C: Assess complete response rate at 9 months. Cohort B: Assess disease-free rate at 9 months

    Measured: 9 months

  4. Response

    Cohort A \& Cohort C: Assess complete response rate at 12 months. Cohort B: Assess disease-free rate at 12 months

    Measured: 12 months

  5. Response

    Cohort A \& Cohort C: Assess complete response rate at 18 months. Cohort B: Assess disease-free rate at 18 months

    Measured: 18 months

  6. Response

    Cohort A \& Cohort C: Assess complete response rate at 24 months. Cohort B: Assess disease-free rate at 24 months

    Measured: 24 months

  7. Complete Response

    Assess complete response rate at any time of CIS patients per central pathology review Duration of complete response (all recurrent bladder cancer, including low grade Ta disease)

    Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2017 (estimated)
  2. Study start2 Jun 2017
  3. Primary completion1 Oct 2024
  4. Study completion1 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
190 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03022825
Sponsor's protocol ID
CA-ALT-803-01-16
Status last verified
Oct 2025
First submitted
13 Jan 2017
Last updated
16 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40956664

  • 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.

    PubMed 38953850

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing N-803 and BCG and N-803 in people with Bladder Cancer, run by ImmunityBio, Inc. at 28 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Response (time frame: 60 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03022825, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2025.

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