A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer
A Study of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With Non-Muscle Invasive Bladder Cancer
1 other identifier
interventional
369
3 countries
108
Brief Summary
This is a Phase Ib/IIb, randomized, two-cohort, open-label, multicenter study of intravesical N-803 plus BCG versus BCG alone, in BCG naïve patients with high-grade NMIBC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2014
Longer than P75 for phase_1
108 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2014
CompletedFirst Posted
Study publicly available on registry
May 15, 2014
CompletedStudy Start
First participant enrolled
July 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 4, 2039
March 31, 2026
March 1, 2026
12.2 years
May 13, 2014
March 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Complete Response (CR) Rate
Patients in Cohort A: compare complete response rate between treatment arms using cystoscopy, confirmatory bladder biopsy and urine cytology.
6 Months
Disease Free Survival (DFS)
Patients in Cohort B: compare disease-free survival between treatment arms using cystoscopy, confirmatory bladder biopsy and urine cytology.
13 Years and 3 Months
Secondary Outcomes (14)
Progression-free survival (PFS)
13 Years and 3 Months
Overall survival
13 Years and 3 months
Disease specific survival
13 Years and 3 months
Time to disease worsening
13 Years and 3 Months
Cystectomy Free Rate
13 years and 3 months
- +9 more secondary outcomes
Other Outcomes (3)
Exploratory Endpoints- Immunogenicity: Serum level of anti-N-803 in patient samples
36 Months
Quality of Life Endpoint
39 Months
Exploratory Endpoints- Whole Slide Images (Baseline and any on-study biopsy)
39 Months
Study Arms (2)
N-803+BCG
EXPERIMENTAL(Phase Ib and IIb) for BCG-naive patients
BCG alone
ACTIVE COMPARATOR(Phase IIb) for BCG-naive patients
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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).
- Cohort A: Histologically confirmed CIS (with or without Ta/T1 disease); Cohort B: Histologically confirmed high-grade papillary disease (Ta/T1 only).
- 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.
- Upper tract imaging within 6 months prior to study entry must not be suspicious for upper tract malignancy.
- Currently eligible for intravesical BCG therapy.
- Age ≥ 18 years.
- Performance status: ECOG performance status of 0, 1, or 2.
- BCG-naive disease as defined as either of the following:
- Have not received prior intravesical BCG; or
- Previously received BCG, but stopped receiving more than 3 years before date of randomization.
- Laboratory tests performed within 21 days of treatment start:
- Absolute lymphocyte count ≥ Institutional lower limit of normal
- Absolute neutrophil count (AGC/ANC) ≥ 1,000/μL
- Platelets ≥ 100,000/µL \[Patients may be transfused to meet this requirement\]
- Hemoglobin ≥ 8 g/dL \[Patients may be transfused to meet this requirement\]
- +8 more criteria
You may not qualify if:
- Prior BCG treatment or known hypersensitivity to BCG. Patients who have received more than a single-dose post-operative treatment of mitomycin-C or gemcitabine following the most recent screening TURBT/biopsy are excluded.
- Concurrent use of other investigational agents (not including FDA-authorized drugs for the prevention and treatment of COVID-19).
- 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).
- Symptomatic congestive heart failure (CHF), NYHA (New York Heart Association) Class III or IV 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 CNS disease.
- Known HIV-positive.
- 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.
- Psychiatric illness/social situations that would limit compliance with study requirements.
- Other illness that in the opinion of the investigator would exclude the patient from participating in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (108)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Alaska Clinical Research Center
Anchorage, Alaska, 99503, United States
Mayo Clinic
Phoenix, Arizona, 85054, United States
Center for Neurosciences
Tucson, Arizona, 85718, United States
Arkansas Urology
Little Rock, Arkansas, 72211, United States
Hoag Memorial Hospital Presbyterian
Irvine, California, 92618, United States
University of Southern California
Los Angeles, California, 90033, United States
UCLA Department of Urology
Los Angeles, California, 90095, United States
University of California, Irvine Medical Center
Orange, California, 92868, United States
University of California, Davis
Sacramento, California, 95817, United States
Golden State Urology
Sacramento, California, 95823, United States
University of California San Diego
San Diego, California, United States
Skyline Sherman Oaks
Sherman Oaks, California, 91411, United States
Skyline Urology
Torrance, California, 90505, United States
Eastern Connecticut Hematology & Oncology Associates
Norwich, Connecticut, 06360, United States
Memorial Healthcare System
Hollywood, Florida, 33021, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Advanced Urology Institute
Oxford, Florida, 34484, United States
Clinical Research Center of Florida
Pompano Beach, Florida, 33060, United States
Florida Urology Partners
Riverview, Florida, 33578, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Emory University
Atlanta, Georgia, 30322, United States
Georgia Urology
Atlanta, Georgia, 30328, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813, United States
Associated Urological Specialists
Chicago, Illinois, 60415, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush University
Chicago, Illinois, 60612, United States
UroPartners, LLC.
Glenview, Illinois, 60026, United States
Urology of Indiana
Carmel, Indiana, 46032, United States
Kansas University Medical Center
Westwood, Kansas, 66205, United States
Wichita Urology
Wichita, Kansas, 67226, United States
University of Kentucky Markey Cancer Center
Lexington, Kentucky, 40508, United States
Mary Bird Perkins Cancer Center
Metairie, Louisiana, 70002, United States
Anne Arundel Urology
Annapolis, Maryland, 21401, United States
Greater Boston Urology
Plymouth, Massachusetts, 02360, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Comprehensive Urology
Royal Oak, Michigan, 48703, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Minnesota Urology
Woodbury, Minnesota, 55125, United States
Specialty Clinical Research of St. Louis
St Louis, Missouri, 63141, United States
Adult & Pediatric Urology
Omaha, Nebraska, 68114, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Summit Health
Florham Park, New Jersey, 07932, United States
Urology Group of New Mexico (AccumetRx Clinical Research)
Albuquerque, New Mexico, 87109, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
Integrated Medical Professionals
New York, New York, 10016, United States
NYU Langone Health
New York, New York, 10016, United States
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, 12601, United States
Associated Medical Professionals of NY
Syracuse, New York, 13210, United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27278, United States
Associated Urologists of North Carolina
Raleigh, North Carolina, 27612, United States
Dayton Physicians Network
Centerville, Ohio, 45459, United States
The Urology Group
Cincinnati, Ohio, 45212, United States
University of Cincinnati Cancer Center
Cincinnati, Ohio, 45267, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Central Ohio Urology Group
Gahanna, Ohio, 43230, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19141, United States
Lowcountry Urology Clinics
North Charleston, South Carolina, 29406, United States
Erlanger Health
Chattanooga, Tennessee, 37403, United States
Urology Associates, PC
Nashville, Tennessee, 37209, United States
Urology Partners of North Texas
Arlington, Texas, 76017, United States
Texas Oncology
Austin, Texas, 78705, United States
Urology Austin, PLLC
Austin, Texas, 78745, United States
Houston Metro Urology
Houston, Texas, 77027, United States
Urology San Antonio
San Antonio, Texas, 78229, United States
Potomac Urology
Alexandria, Virginia, 22311, United States
Virginia Urology
Richmond, Virginia, 23235, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Urology of Virginia
Virginia Beach, Virginia, 23462, United States
University of Washington School of Medicine
Seattle, Washington, 98195, United States
Spokane Urology
Spokane, Washington, 99202, United States
HCG Cancer Centre
Visakhapatnam, Andhra Pradesh, 530040, India
Adyar Cancer Institute
Adyār, Chennai, 600036, India
HCG Aastha Cancer Centre
Ahmedabad, Gujarat, 380060, India
Darakh Nursing Home and Kidney Stone Centre
Aurangabad, Maharashtra, 431001, India
Kidney Centre Jasleen Hospital
Nagpur, Maharashtra, 440012, India
Indriyani Hospital & Cancer Institute
Pune, Maharashtra, 412105, India
HCG Manavata Cancer Centre
Mumbai, Nashik, 422002, India
BLK-Max Super Specialty Hospital
New Delhi, National Capital Territory of Delhi, 1100005, India
All India Institute of Medical Sciences,
Bhubaneswar, Odisha, 751019, India
Sri Guru Ram Das Institute of Medical Sciences and Research
Amritsar, Punjab, 143501, India
Urocare Hospital
Guntur, Rajkort, 360002, India
Erode Cancer Centre
Erode, Tamilnadu. India, 638012, India
Pi Health Cancer Hospital
Hyderabad, Telangana, 500032, India
Max Super Specialty Hospital
Ghaziabad, Uttar Pardesh, 201012, India
Pushpanjali Hospital & Research Centre
Agra, Uttar, 282002, India
Swami Harshankaranand JI Hospital and Research Centre
Sunderpur, Varanasi, 221005, India
Govt. Medical College, Kolkata
Kolkata, West Bengal, 700073, India
B J Medical College & Civil Hospital, Asarwa, Ahmedaba
Ahmedabad, India
Basavatarakam Indo American Cancer Hospital & Research Institute
Banjara Hills, India
HCG Bangalore
Bengaluru, 560027, India
SP Medical College and Hospital
Bikaner, 334003, India
Guru Govnid Singh Medical College and Hospital
Farīdkot, 151203, India
Muljibhai Patel Urological Hospital
Gujrāt, India
Binayak Multispecialty Hospital
Kolkata, 700050, India
Chittaranjan National Cancer Institute
Kolkata, India
KR Hospital
Mysuru, 570001, India
KMC Manipal
Nagar, 576104, India
Jasleen Hospital
Nagpur, 440012, India
Onco Life Cancer Center
Pune, 410506, India
Inamdar Hospital Pune
Pune, 411040, India
Urocare Hospital
Rajkot, India
All India Institute of Medical Sciences, Raipur
Rajpura, 492099, India
Uttar Pradesh University of Medical Sciences
Uttar, India
HCG cancer Centre, Vizag
Visakhapatnam, 530040, India
Apollo Vizag
Visakhapatnam, India
SunningHill Hospital
Sandton, 2191, South Africa
Related Publications (1)
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: 38953850DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bobby Reddy, MD
ImmunityBio, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2014
First Posted
May 15, 2014
Study Start
July 21, 2014
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
March 4, 2039
Last Updated
March 31, 2026
Record last verified: 2026-03