Cure My Disease

Don't miss your cure!

 Log in / Sign up

New bladder cancer combo shows promise for Tough-to-Treat cases

NCT ID NCT03022825

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Summary

This study tests a new treatment for people with a type of bladder cancer that has not improved with standard therapy. The treatment combines a standard immunotherapy (BCG) with an experimental drug (N-803), both given directly into the bladder through a catheter. The goal is to see if this combination can control the cancer and prevent it from coming back. About 190 adults with high-grade non-muscle invasive bladder cancer are participating.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

190 people

The number who actually took part.

Started

Jun 2017

Expected to finish

Mar 2029

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: * 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 Exclusion Criteria: * 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). * 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for BCG-unresponsive high-grade non-muscle invasive bladder cancer are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms urinary bladder carcinoma Urinary Bladder Neoplasms

As listed by the trial registrant

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

Bladder cancer

Contacts and locations

Locations

  • Accument Rx

    Albuquerque, New Mexico, 87109, United States

  • Adult & Pediatric Urology

    Omaha, Nebraska, 68114, United States

  • Alaska Clinical Research Center

    Anchorage, Alaska, 99503, United States

  • Arkansas Urology

    Little Rock, Arkansas, 72211, United States

  • Associated Urologists of North Carolina

    Raleigh, North Carolina, 27612, United States

  • Clinical Research Center of Florida

    Pompano Beach, Florida, 33060, United States

  • Dwight D. Eisenhower Army Medical Center

    Augusta, Georgia, 30905, United States

  • Hoag Memorial Hospital

    Newport Beach, California, 92663, United States

  • Integrated Medical Professionals

    New York, New York, 10016, United States

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Madigan Army Medical Center

    Tacoma, Washington, 98431, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Premier Medical Group of the Hudson Valley

    Poughkeepsie, New York, 12601, United States

  • Roswell Park Cancer Insitute

    Buffalo, New York, 14263, United States

  • Skyline Urology

    Sherman Oaks, California, 91411, United States

  • Skyline Urology

    Torrance, California, 90505, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • UCLA Department of Urology

    Los Angeles, California, 90024, United States

  • UNC Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • University of Chicago Medical Center

    Chicago, Illinois, 60637, United States

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96814, United States

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

    Miami, Florida, 33136, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Rochester

    Rochester, New York, 14642, United States

  • Urology Associates, PC

    Englewood, Colorado, 80113, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Virginia Urology

    Richmond, Virginia, 23235, United States

  • Winthrop University Hospital Department of Urology

    Garden City, New York, 11530, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.