Immune booster plus standard therapy shows promise for bladder cancer

NCT ID NCT02138734

Disease control Sponsor: ImmunityBio, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding an immune-boosting drug called N-803 to the standard BCG treatment works better than BCG alone for people with a high-risk type of bladder cancer that hasn't invaded the muscle. About 369 participants will receive either the combination or BCG alone, given directly into the bladder. The goal is to see if the combination leads to a complete response or longer disease-free survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: BCG (a weakened tuberculosis germ) combined with N-803 (an immune-boosting protein)
What this could lead to: If it works, this could offer a more effective treatment for high-risk bladder cancer, potentially reducing the chance of cancer coming back or getting worse.
What could go wrong: This is an early-phase trial (Phase 1/2), so the combination may not work better than BCG alone. Side effects from the immune boost could be significant, and long-term benefits are not yet known.

Why investors are watching

ImmunityBio is testing its drug N-803 with the standard bladder cancer treatment BCG in patients with high-grade non-muscle invasive bladder cancer. The trial compares the combination against BCG alone, and the result matters because this small company's value depends heavily on whether its drug works in this common cancer setting.

If it works: A positive result could show that adding N-803 to BCG controls the cancer better than BCG alone, which might lead to regulatory approval and a new revenue source for the company.

If it fails: The trial could fail to show an advantage over BCG alone, or face delays, which would hurt the company's prospects. Trials in cancer often fail, so a negative outcome is a real possibility.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

369 people

The number who actually took part.

Started

Jul 2014

Expected to finish

Mar 2039

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria 1. 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). 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 1. 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. 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.

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Conditions

The condition(s) this trial relates to.

neoplasm non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms transitional cell carcinoma Urinary Bladder Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-muscle invasive bladder cancer

Contacts and locations

Locations

Adult & Pediatric Urology

Omaha, Nebraska, 68114, United States
Advanced Urology Institute

Oxford, Florida, 34484, United States
Adyar Cancer Institute

Adyār, Chennai, 600036, India
Alaska Clinical Research Center

Anchorage, Alaska, 99503, United States
All India Institute of Medical Sciences,

Bhubaneswar, Odisha, 751019, India
All India Institute of Medical Sciences, Raipur

Rajpura, 492099, India
Anne Arundel Urology

Annapolis, Maryland, 21401, United States
Apollo Vizag

Visakhapatnam, India
Arkansas Urology

Little Rock, Arkansas, 72211, United States
Associated Medical Professionals of NY

Syracuse, New York, 13210, United States
Associated Urological Specialists

Chicago, Illinois, 60415, United States
Associated Urologists of North Carolina

Raleigh, North Carolina, 27612, United States
B J Medical College & Civil Hospital, Asarwa, Ahmedaba

Ahmedabad, India
BLK-Max Super Specialty Hospital

New Delhi, National Capital Territory of Delhi, 1100005, India
Basavatarakam Indo American Cancer Hospital & Research Institute

Banjara Hills, India
Binayak Multispecialty Hospital

Kolkata, 700050, India
Center for Neurosciences

Tucson, Arizona, 85718, United States
Central Ohio Urology Group

Gahanna, Ohio, 43230, United States
Chittaranjan National Cancer Institute

Kolkata, India
Clinical Research Center of Florida

Pompano Beach, Florida, 33060, United States
Comprehensive Urology

Royal Oak, Michigan, 48703, United States
Darakh Nursing Home and Kidney Stone Centre

Aurangabad, Maharashtra, 431001, India
Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States
Dayton Physicians Network

Centerville, Ohio, 45459, United States
Eastern Connecticut Hematology & Oncology Associates

Norwich, Connecticut, 06360, United States
Emory University

Atlanta, Georgia, 30322, United States
Erlanger Health

Chattanooga, Tennessee, 37403, United States
Erode Cancer Centre

Erode, Tamilnadu. India, 638012, India
Florida Urology Partners

Riverview, Florida, 33578, United States
Georgia Urology

Atlanta, Georgia, 30328, United States
Golden State Urology

Sacramento, California, 95823, United States
Govt. Medical College, Kolkata

Kolkata, West Bengal, 700073, India
Greater Boston Urology

Plymouth, Massachusetts, 02360, United States
Guru Govnid Singh Medical College and Hospital

Farīdkot, 151203, India
HCG Aastha Cancer Centre

Ahmedabad, Gujarat, 380060, India
HCG Bangalore

Bengaluru, 560027, India
HCG Cancer Centre

Visakhapatnam, Andhra Pradesh, 530040, India
HCG Manavata Cancer Centre

Mumbai, Nashik, 422002, India
HCG cancer Centre, Vizag

Visakhapatnam, 530040, India
Hoag Memorial Hospital Presbyterian

Irvine, California, 92618, United States
Houston Metro Urology

Houston, Texas, 77027, United States
Inamdar Hospital Pune

Pune, 411040, India
Indriyani Hospital & Cancer Institute

Pune, Maharashtra, 412105, India
Integrated Medical Professionals

New York, New York, 10016, United States
Jasleen Hospital

Nagpur, 440012, India
KMC Manipal

Nagar, 576104, India
KR Hospital

Mysuru, 570001, India
Kansas University Medical Center

Westwood, Kansas, 66205, United States
Karmanos Cancer Institute

Detroit, Michigan, 48201, United States
Kidney Centre Jasleen Hospital

Nagpur, Maharashtra, 440012, India
Lowcountry Urology Clinics

North Charleston, South Carolina, 29406, United States
Mary Bird Perkins Cancer Center

Metairie, Louisiana, 70002, United States
Max Super Specialty Hospital

Ghaziabad, Uttar Pardesh, 201012, India
Mayo Clinic

Phoenix, Arizona, 85054, United States
Mayo Clinic

Jacksonville, Florida, 32224, United States
Mayo Clinic

Rochester, Minnesota, 55905, United States
Memorial Healthcare System

Hollywood, Florida, 33021, United States
MidLantic Urology

Bala-Cynwyd, Pennsylvania, 19004, United States
Minnesota Urology

Woodbury, Minnesota, 55125, United States
Moffitt Cancer Center

Tampa, Florida, 33612, United States
Muljibhai Patel Urological Hospital

Gujrāt, India
NYU Langone Health

New York, New York, 10016, United States
Northwestern University

Chicago, Illinois, 60611, United States
Onco Life Cancer Center

Pune, 410506, India
Pi Health Cancer Hospital

Hyderabad, Telangana, 500032, India
Potomac Urology

Alexandria, Virginia, 22311, United States
Premier Medical Group of the Hudson Valley

Poughkeepsie, New York, 12601, United States
Pushpanjali Hospital & Research Centre

Agra, Uttar, 282002, India
Rush University

Chicago, Illinois, 60612, United States
SP Medical College and Hospital

Bikaner, 334003, India
Skyline Sherman Oaks

Sherman Oaks, California, 91411, United States
Skyline Urology

Torrance, California, 90505, United States
Specialty Clinical Research of St. Louis

St Louis, Missouri, 63141, United States
Spokane Urology

Spokane, Washington, 99202, United States
Sri Guru Ram Das Institute of Medical Sciences and Research

Amritsar, Punjab, 143501, India
Summit Health

Florham Park, New Jersey, 07932, United States
SunningHill Hospital

Sandton, 2191, South Africa
Swami Harshankaranand JI Hospital and Research Centre

Sunderpur, Varanasi, 221005, India
Texas Oncology

Austin, Texas, 78705, United States
The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States
The Urology Group

Cincinnati, Ohio, 45212, United States
Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19141, United States
UCLA Department of Urology

Los Angeles, California, 90095, United States
University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States
University of California San Diego

San Diego, California, United States
University of California, Davis

Sacramento, California, 95817, United States
University of California, Irvine Medical Center

Orange, California, 92868, United States
University of Cincinnati Cancer Center

Cincinnati, Ohio, 45267, United States
University of Hawaii Cancer Center

Honolulu, Hawaii, 96813, United States
University of Kentucky Markey Cancer Center

Lexington, Kentucky, 40508, United States
University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 27278, United States
University of Southern California

Los Angeles, California, 90033, United States
University of Washington School of Medicine

Seattle, Washington, 98195, United States
UroPartners, LLC.

Glenview, Illinois, 60026, United States
Urocare Hospital

Guntur, Rajkort, 360002, India
Urocare Hospital

Rajkot, India
Urology Associates, PC

Nashville, Tennessee, 37209, United States
Urology Austin, PLLC

Austin, Texas, 78745, United States
Urology Group of New Mexico (AccumetRx Clinical Research)

Albuquerque, New Mexico, 87109, United States
Urology Partners of North Texas

Arlington, Texas, 76017, United States
Urology San Antonio

San Antonio, Texas, 78229, United States
Urology of Indiana

Carmel, Indiana, 46032, United States
Urology of Virginia

Virginia Beach, Virginia, 23462, United States
Uttar Pradesh University of Medical Sciences

Uttar, India
Virginia Commonwealth University

Richmond, Virginia, 23298, United States
Virginia Urology

Richmond, Virginia, 23235, United States
Wichita Urology

Wichita, Kansas, 67226, United States
Winthrop University Hospital

Mineola, New York, 11501, United States

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