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Bladder cancer breakthrough? virus therapy aims to stop recurrence

NCT ID NCT06111235

Disease control Sponsor: CG Oncology, 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Updated 2 times

Summary

This phase 3 trial tests whether a virus-based drug called cretostimogene grenadenorepvec can prevent intermediate-risk bladder cancer from coming back after surgery. About 367 participants will either receive the drug or be monitored as usual. The goal is to see if the treatment extends the time without cancer recurrence.

What this could mean

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

Active substance
Cretostimogene grenadenorepvec (a modified virus that targets cancer cells)
What this could lead to
If successful, this treatment could help prevent bladder cancer from coming back after surgery, reducing the need for repeated procedures.
What could go wrong
This is still an experimental therapy, and it may not work better than standard surveillance. Possible side effects from the virus-based treatment are still being studied.
Why investors are watching

CG Oncology is running a Phase 3 trial testing its drug cretostimogene grenadenorepvec as an add-on treatment after surgery for a type of early-stage bladder cancer. The trial compares patients who receive the drug to those who simply get standard monitoring. For a small company, this readout is a major test of whether its lead drug can delay cancer return, which would shape the company's future.

If it works: If the trial shows the drug keeps cancer from coming back longer than monitoring alone, CG Oncology would have strong evidence its product works. That result could support a path to regulatory approval and make the drug a core part of the company's business.

If it fails: The trial could fail to show a meaningful benefit, or the drug could cause safety problems. Trials in cancer often fail, and a negative result would leave CG Oncology without a proven product, which would be a serious setback for a company of this size.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

367 people

The number who actually took part.

Started

Dec 2023

Expected to finish

Feb 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: * Pathologically confirmed IR-NMIBC, per American Urologic Association/Society of Urologic Oncology/National Comprehensive Cancer Network guidelines, within 90 days of participant randomization: 1. Recurrent LG Ta within 12 months of prior LG or HG (HG Ta ≤ 3 cm) tumor 2. Solitary LG Ta \>3 cm tumor 3. Multifocal LG Ta tumors 4. Primary and solitary HG Ta ≤3 cm tumor 5. LG T1 tumor * All visible disease removed by TURBT within 90 days of study randomization * Acceptable baseline organ function Exclusion Criteria: * High-risk NMIBC (e.g., HG T1, Recurrent or multifocal HG Ta\>3cm tumor(s), CIS) * Low-Risk NMIBC (e.g., solitary LG Ta ≤3 cm tumor) * Disease in the prostatic urethra at any time or in the upper genitourinary tract within 24 months of randomization * Muscle-invasive bladder cancer, locally advanced or metastatic bladder cancer * Prior treatment with any human adenovirus serotype 5 based therapy (e.g., Adstiladrin)

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Conditions

The condition(s) this trial relates to.

benign urinary system neoplasm malignant urinary system neoplasm non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms transitional cell carcinoma urinary bladder carcinoma Urinary Bladder Neoplasms urothelial carcinoma

As listed by the trial registrant

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

Bladder cancer Non-muscle invasive bladder cancer Urologic cancer Urothelial carcinoma

Contacts and locations

Locations

  • Advanced Urology Institute

    Daytona Beach, Florida, 32114, United States

  • Advanced Urology Institute, LLC

    Largo, Florida, 33771, United States

  • Amarillo Urology Research, LLC

    Amarillo, Texas, 79106, United States

  • Arizona Institute of Urology PLLC

    Tucson, Arizona, 85745, United States

  • Arkansas Urology PA

    Little Rock, Arkansas, 72211, United States

  • Associated Medical Professionals of NY

    Syracuse, New York, 13202, United States

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • Benaroya Research Institute at Virginia Mason

    Seattle, Washington, 98101, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02215, United States

  • Cancer Center at Beth Israel Deaconess Medical Center - Research

    Boston, Massachusetts, 02215, United States

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572, United States

  • Charleston Area Medical Center

    Charleston, West Virginia, 25304, United States

  • Chesapeake Urology Associates, LLC

    Baltimore, Maryland, 21204, United States

  • Colorado Clinical Research

    Aurora, Colorado, 80012, United States

  • Comprehensive Urology

    Roseville, Michigan, 48066, United States

  • Duke Cancer Center

    Durham, North Carolina, 27710, United States

  • Duly Health and Care

    Lisle, Illinois, 601152, United States

  • Emory Winship Cancer Center

    Atlanta, Georgia, 30322, United States

  • First Urology, PSC

    Louisville, Kentucky, 47130, United States

  • Garden State Urology, LLC- Morristown Medical Center

    Morristown, New Jersey, 07962, United States

  • Hartford HealthCare Medical Group

    Hartford, Connecticut, 06106, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Houston Methodist Research Institute

    Houston, Texas, 77030, United States

  • Houston Metro Urology

    Houston, Texas, 77074, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Integrated Medical Professionals PLLC

    New York, New York, 10016, United States

  • Johns Hopkins Hospital Green Spring Station

    Baltimore, Maryland, 21287, United States

  • Keystone Urology Specialists

    Lancaster, Pennsylvania, 17604, United States

  • Lakeland Regional Health

    Lakeland, Florida, 33805, United States

  • London Health Sciences Centre

    London, Ontario, N6A 5W9, Canada

  • Lowcountry Urology Clinics

    North Charleston, South Carolina, 29406, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Mayo Clinic

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic Cancer Center

    Jacksonville, Florida, 32224, United States

  • McGill University Health Center - Montreal General Hospital

    Montreal, Quebec, H4A 3J1, Canada

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Michael E. DeBakey VA Medical Center

    Houston, Texas, 77030, United States

  • Michael G. Oefelein MD Clinical Trials

    Bakersfield, California, 93301-2284, United States

  • Michigan Institute of Urology, PC

    Troy, Michigan, 48084, United States

  • Midlantic Urology

    Bala-Cynwyd, Pennsylvania, 19004, United States

  • Montefiore Medical Center

    The Bronx, New York, 10461, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • Nova Scotia Health Centre of Applied Urology Research

    Halifax, Nova Scotia, B3H 2Y9, Canada

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

  • Oregon Urology Insititute

    Springfield, Oregon, 97477, United States

  • Penn State Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Regional Urology, LLC

    Shreveport, Louisiana, 71106, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Rutgers Cancer Institute of New Jersey - Cancer Center

    New Brunswick, New Jersey, 08901, United States

  • SUNY Upstate Medical University

    Syracuse, New York, 13210, United States

  • Southern Urology

    Lafayette, Louisiana, 70508, United States

  • Specialty Clinical Research of St. Louis

    St Louis, Missouri, 63141, United States

  • Spokane Urology- Southside

    Spokane, Washington, 99202, United States

  • Stanford University School of Medicine

    Stanford, California, 94305, United States

  • Stony Brook University

    Stony Brook, New York, 11794, United States

  • Sun Kim Urology

    Orange, California, 92868, United States

  • The Conrad Pearson Clinic

    Germantown, Tennessee, 38138, United States

  • The Miriam Hospital

    Providence, Rhode Island, 02905, United States

  • The University of Kansas Cancer Center

    Westwood, Kansas, 66205, United States

  • The Urology Group

    Southaven, Mississippi, 38671, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • Tower Urology

    Los Angeles, California, 90048, United States

  • USC/Keck Department of Urology

    Los Angeles, California, 90033, United States

  • UT Health San Antonio

    San Antonio, Texas, 78229, United States

  • University Health Network (UHN) - Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 1Z5, Canada

  • University of California Davis Cancer Center

    Sacramento, California, 95817, United States

  • University of California Irvine Medical Center (UCIMC)

    Orange, California, 92868, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • University of Pennsylvania - Perelman School of Medicine

    Philadelphia, Pennsylvania, 19104, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University of Toledo

    Toledo, Ohio, 43614, United States

  • University of Utah- Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

  • University of Wisconsin Medical Foundation

    Madison, Wisconsin, 53705, United States

  • UroPartners LLC

    Glenview, Illinois, 60026, United States

  • Urology Associates of North Texas

    Arlington, Texas, 76017, United States

  • Urology Associates, P.C.

    Nashville, Tennessee, 37209, United States

  • Urology Associates, PC

    Lone Tree, Colorado, 80124, United States

  • Urology Austin, PLLC

    Austin, Texas, 78745, United States

  • Urology Center of Iowa Research

    West Des Moines, Iowa, 50266, United States

  • Urology Centers of Alabama PC

    Homewood, Alabama, 35209, United States

  • Urology Group

    Cincinnati, Ohio, 45212, United States

  • Urology Nevada

    Reno, Nevada, 89511, United States

  • Urology San Antonio PA

    San Antonio, Texas, 78229, United States

  • Urology of Indiana

    Greenwood, Indiana, 46143, United States

  • Urology of Indiana, LLC

    Carmel, Indiana, 46032, United States

  • Urology of Virginia (UVA) - Virginia Beach (Devine-Tidewater Urology)

    Virginia Beach, Virginia, 23462, United States

  • Vancouver Prostate Centre

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Velocity Clinical Research- Savanah Urological Associates

    Savannah, Georgia, 31405, United States

  • Wichita Urology Group

    Wichita, Kansas, 67226, United States

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