A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer
NCT ID: NCT02138734
Last Updated: 2025-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
596 participants
INTERVENTIONAL
2014-07-21
2038-12-31
Brief Summary
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Detailed Description
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In the phase Ib, patients will be treated with intravesical N-803 in combination with BCG. The purpose of the phase Ib portion of the study is to evaluate the safety, identify the Maximum Tolerated Dose (MTD) of N-803 and determine the Recommended Dose (RD) level of N-803 in combination with BCG for the phase IIb expansion.
In the phase IIb expansion, patients will be randomized to receive either intravesical N-803 in combination with BCG or BCG alone. Patients will be enrolled into one of two study cohorts (Cohort A and Cohort B). These will be two independent study cohorts, evaluated separately for treatment efficacy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Two-arm phase IIb, two-cohort: each randomized 1:1 via randomization scheme stratified by disease and ECOG status.
Cohort A: patients with CIS disease (with or without Ta/T1); planned enrollment = 366 Cohort B: patients with high-grade papillary disease (Ta/T1 only); planned enrollment = 230
TREATMENT
NONE
Study Groups
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N-803+BCG
(Phase Ib and IIb) for BCG-naive patients
BCG+N-803( 50mg BCG/ Instillation+ N-803( 400 μg/instillation). )
BCG and N-803 will be mixed together (with saline) and administered via intravesical instillation weekly for 6 consecutive weeks for induction. Phase IIb includes maintenance treatment consisting of BCG+N-803 for 3 consecutive weeks at 3, 6, 12, 18, 24,30 and 36 months.
An additional 6 week re-induction of BCG+N-803 for patients with eligible disease at 3 months in phase IIb is included.
BCG alone
(Phase IIb) for BCG-naive patients
BCG( 50mg/Instillation)
BCG will be administered via intravesical instillation weekly for 6 consecutive weeks for induction. Phase IIb includes maintenance treatment consisting of BCG for 3 consecutive weeks at 3, 6, 12, 18, 24, 30 and 36 months.
An additional 6 week re-induction of BCG for patients with eligible disease at 3 months in phase IIb is included.
Interventions
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BCG+N-803( 50mg BCG/ Instillation+ N-803( 400 μg/instillation). )
BCG and N-803 will be mixed together (with saline) and administered via intravesical instillation weekly for 6 consecutive weeks for induction. Phase IIb includes maintenance treatment consisting of BCG+N-803 for 3 consecutive weeks at 3, 6, 12, 18, 24,30 and 36 months.
An additional 6 week re-induction of BCG+N-803 for patients with eligible disease at 3 months in phase IIb is included.
BCG( 50mg/Instillation)
BCG will be administered via intravesical instillation weekly for 6 consecutive weeks for induction. Phase IIb includes maintenance treatment consisting of BCG for 3 consecutive weeks at 3, 6, 12, 18, 24, 30 and 36 months.
An additional 6 week re-induction of BCG for patients with eligible disease at 3 months in phase IIb is included.
Eligibility Criteria
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Inclusion Criteria
1. Cohort A: Histologically confirmed CIS (with or without Ta/T1 disease); Cohort B: Histologically confirmed high-grade papillary disease (Ta/T1 only).
2. Patients are eligible if the diagnostic biopsy was done within 3 months of treatment start and a cystoscopy demonstrating no resectable disease was done within 6 calendar weeks (inclusive of 48 days) of treatment start (residual CIS is acceptable; patients with T1 disease must undergo repeat resection if muscularis propria is not present in each biopsy sample). Patients with high-grade Ta and/or T1 disease should have complete resection before study treatment.
3. Upper tract imaging within 6 months prior to study entry must not be suspicious for upper tract malignancy.
2. Currently eligible for intravesical BCG therapy.
3. Age ≥ 18 years.
4. Performance status: ECOG performance status of 0, 1, or 2.
5. BCG-naive disease as defined as either of the following:
1. Have not received prior intravesical BCG; or
2. Previously received BCG, but stopped receiving more than 3 years before date of randomization.
6. Laboratory tests performed within 21 days of treatment start:
1. Absolute lymphocyte count ≥ Institutional lower limit of normal
2. Absolute neutrophil count (AGC/ANC) ≥ 1,000/μL
3. Platelets ≥ 100,000/µL \[Patients may be transfused to meet this requirement\]
4. Hemoglobin ≥ 8 g/dL \[Patients may be transfused to meet this requirement\]
5. Calculated glomerular filtration rate (GFR\*) \>40 mL/min or Serum creatinine ≤ 1.5 x ULN
6. Total bilirubin ≤ 2.0 X ULN
7. AST, ALT, ALP ≤ 3.0 X ULN
7. Adequate pulmonary function without any clinical sign of severe pulmonary dysfunction. PFT \> 50% FEV1 if clinically indicated by the investigator.
8. Negative serum pregnancy test if female and of childbearing potential (non-childbearing is defined as greater than one year postmenopausal or surgically sterilized).
9. Female participants of childbearing potential must adhere to using a medically accepted method of birth control prior to screening and agree to continue its use during the study or be surgically sterilized (e.g., hysterectomy or tubal ligation) and males must agree to use barrier methods of birth control while on study.
10. Provide signed informed consent and HIPPA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations.
* using the following Cockcroft-Gault equation to calculate the eGFR for this study: eGFR in mL/min = {(140-age in years) x (weight in kg) x F}/(serum creatinine in mg/dL x 72) Where F =1 if male; and 0.85 if female
Exclusion Criteria
2. Concurrent use of other investigational agents (not including FDA-authorized drugs for the prevention and treatment of COVID-19).
3. History of or evidence of muscle-invasive, locally advanced, metastatic and/or extravesical bladder cancer or any other cancer within the past 5 years, except: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage 1 or 2 cancer from which the patient is currently in complete remission, or stable prostate cancer (under active surveillance or hormone control).
4. Symptomatic congestive heart failure (CHF), NYHA (New York Heart Association) Class III or IV or other clinical signs of severe cardiac dysfunction.
5. Severe/unstable angina pectoris, or myocardial infarction within 6 months prior to study entry.
6. History or evidence of uncontrollable CNS disease.
7. Known HIV-positive.
8. Active systemic infection requiring parenteral antibiotic therapy. All prior infections must have resolved following optimal therapy.
9. Concurrent febrile illness, active urinary tract infection, active tuberculosis, a history of hypotension or anaphylactic reactions.
10. Ongoing chronic systemic steroid therapy required (\>10 mg oral prednisone daily or equivalent).
11. 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.
12. Psychiatric illness/social situations that would limit compliance with study requirements.
13. Other illness that in the opinion of the investigator would exclude the patient from participating in this study.
18 Years
ALL
No
Sponsors
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ImmunityBio, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Bobby Reddy, MD
Role: STUDY_DIRECTOR
ImmunityBio, Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Alaska Clinical Research Center
Anchorage, Alaska, United States
Arkansas Urology
Little Rock, Arkansas, United States
Hoag Cancer Center
Irvine, California, United States
UCLA Department of Urology
Los Angeles, California, United States
University of California, Davis
Sacramento, California, United States
University of California San Diego
San Diego, California, United States
Skyline Sherman Oaks
Sherman Oaks, California, United States
Skyline Urology
Torrance, California, United States
Eastern Connecticut Hematology & Oncology Associates
Norwich, Connecticut, United States
Memorial Healthcare System
Hollywood, Florida, United States
Advanced Urology Institute
Oxford, Florida, United States
Clinical Research Center of Florida
Pompano Beach, Florida, United States
Florida Urology Partners
Riverview, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
Associated Urological Specialists
Chicago, Illinois, United States
Northwestern University-Feinberg School of Medicine
Chicago, Illinois, United States
Rush University
Chicago, Illinois, United States
UroPartners
Glenview, Illinois, United States
Urology of Indiana
Carmel, Indiana, United States
Kansas University Medical Center
Westwood, Kansas, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Comprehensive Urology
Royal Oak, Michigan, United States
Specialty Clinical Research of St. Louis
St Louis, Missouri, United States
Adult & Pediatric Urology
Omaha, Nebraska, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Urology Group of New Mexico (AccumetRx Clinical Research)
Albuquerque, New Mexico, United States
Winthrop University Hospital
Mineola, New York, United States
Integrated Medical Professionals
New York, New York, United States
NYU Langone Health
New York, New York, United States
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, United States
Associated Medical Professionals of NY
Syracuse, New York, United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States
Associated Urologists of North Carolina
Raleigh, North Carolina, United States
The Urology Group
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Central Ohio Urology Group
Gahanna, Ohio, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Lowcountry Urology Clinics
North Charleston, South Carolina, United States
Erlanger Health
Chattanooga, Tennessee, United States
Urology Associates
Nashville, Tennessee, United States
Urology Partners of North Texas
Arlington, Texas, United States
Texas Oncology
Austin, Texas, United States
Urology Austin, PLLC, Research Department
Austin, Texas, United States
Houston Metro Urology
Houston, Texas, United States
Urology San Antonio
San Antonio, Texas, United States
Potomac Urology
Alexandria, Virginia, United States
Virginia Urology
Richmond, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Urology of Virginia
Virginia Beach, Virginia, United States
University of Washington School of Medicine
Seattle, Washington, United States
HCG Cancer Centre
Visakhapatnam, Andhra Pradesh, India
Darakh Nursing Home and Kidney Stone Centre
Aurangabad, Maharashtra, India
Kidney Centre Jasleen Hospital
Nagpur, Maharashtra, India
Indriyani Hospital & Cancer Institute
Pune, Maharashtra, India
HCG Manavata Cancer Centre
Mumbai, Nashik, India
Erode Cancer Centre
Erode, Tamilnadu. India, India
Pi Health Cancer Hospital
Hyderabad, Telangana, India
Swami Harshankaranand JI Hospital and Research Centre
Sunderpur, Varanasi, India
B J Medical College & Civil Hospital, Asarwa, Ahmedaba
Ahmedabad, , India
Basavatarakam Indo American Cancer Hospital & Research Institute
Banjara Hills, , India
HCG Bangalore
Bengaluru, , India
SP Medical College and Hospital
Bikaner, , India
Guru Govnid Singh Medical College and Hospital
Farīdkot, , India
Muljibhai Patel Urological Hospital
Gujrāt, , India
Binayak Multispecialty Hospital
Kolkata, , India
Chittaranjan National Cancer Institute
Kolkata, , India
KR Hospital
Mysuru, , India
KMC Manipal
Nagar, , India
Jasleen Hospital
Nagpur, , India
Onco Life Cancer Center
Pune, , India
Inamdar Hospital Pune
Pune, , India
Urocare Hospital
Rajkot, , India
All India Institute of Medical Sciences, Raipur
Rajpura, , India
Uttar Pradesh University of Medical Sciences
Uttar, , India
HCG cancer Centre, Vizag
Visakhapatnam, , India
Apollo Vizag
Visakhapatnam, , India
SunningHill Hospital
Sandton, , South Africa
Countries
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Central Contacts
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Facility Contacts
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Sheila Hamilton
Role: primary
Cecilia Diaz
Role: primary
Michelle Le
Role: backup
Deepak Jangid, MD
Role: primary
References
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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.
Other Identifiers
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CA-ALT-803-01-14; QUILT-2.005
Identifier Type: -
Identifier Source: org_study_id
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