A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT

January 9, 2026 updated by: CG Oncology, Inc.

A Phase 3, Randomized Study of Adjuvant Cretostimogene Grenadenorepvec Versus Observation for the Treatment of Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR-NMIBC) Following Transurethral Resection of Bladder Tumor (TURBT)

This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT followed by cretostimogene grenadenorepvec versus TURBT followed by surveillance for the treatment of participants with IR-NMIBC.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants will be randomized 1:1 to cretostimogene grenadenorepvec after TURBT (Arm A) vs surveillance after TURBT (Arm B).

Participants in Arm A will receive an induction course and then quarterly maintenance courses of cretostimogene through Month 13, if there is no disease recurrence.

Disease status will be assessed using urine cytology, cystoscopy, and directed TURBT/biopsy (if indicated) every 3 months for the first 2 years after randomization and then every 6 months for an additional year or until disease recurrence. CT Urogram/MRU every 12 months.

Participants in Arm B who recur with IR-NMIBC after TURBT and surveillance will be offered treatment with cretostimogene as per the treatment schedule in Arm A.

Study Type

Interventional

Enrollment (Actual)

367

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver Prostate Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Nova Scotia Health Centre of Applied Urology Research
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre
      • Toronto, Ontario, Canada, M5G 1Z5
        • University Health Network (Uhn) - Princess Margaret Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Center - Montreal General Hospital
  • United States
    • Alabama
      • Homewood, Alabama, United States, 35209
        • Urology Centers of Alabama PC
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner MD Anderson Cancer Center
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic
      • Tucson, Arizona, United States, 85745
        • Arizona Institute of Urology PLLC
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Arkansas Urology PA
    • California
      • Bakersfield, California, United States, 93301-2284
        • Michael G. Oefelein MD Clinical Trials
      • Los Angeles, California, United States, 90048
        • Tower Urology
      • Los Angeles, California, United States, 90033
        • USC/Keck Department of Urology
      • Orange, California, United States, 92868
        • University of California Irvine Medical Center (UCIMC)
      • Orange, California, United States, 92868
        • Sun Kim Urology
      • Sacramento, California, United States, 95817
        • University of California Davis Cancer Center
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Colorado Clinical Research
      • Lone Tree, Colorado, United States, 80124
        • Urology Associates, PC
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Hartford HealthCare Medical Group
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Medstar Washington Hospital Center
    • Florida
      • Daytona Beach, Florida, United States, 32114
        • Advanced Urology Institute
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Cancer Center
      • Lakeland, Florida, United States, 33805
        • Lakeland Regional Health
      • Largo, Florida, United States, 33771
        • Advanced Urology Institute, LLC
      • Miami, Florida, United States, 33136
        • University of Miami
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Winship Cancer Center
      • Savannah, Georgia, United States, 31405
        • Velocity Clinical Research- Savanah Urological Associates
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Glenview, Illinois, United States, 60026
        • UroPartners LLC
      • Lisle, Illinois, United States, 601152
        • Duly Health and Care
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Urology of Indiana, LLC
      • Greenwood, Indiana, United States, 46143
        • Urology Of Indiana
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Urology Center of Iowa Research
    • Kansas
      • Westwood, Kansas, United States, 66205
        • The University of Kansas Cancer Center
      • Wichita, Kansas, United States, 67226
        • Wichita Urology Group
    • Kentucky
      • Louisville, Kentucky, United States, 47130
        • First Urology, PSC
    • Louisiana
      • Lafayette, Louisiana, United States, 70508
        • Southern Urology
      • Shreveport, Louisiana, United States, 71106
        • Regional Urology, LLC
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Chesapeake Urology Associates, LLC
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital Green Spring Station
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02215
        • Cancer Center at Beth Israel Deaconess Medical Center - Research
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Roseville, Michigan, United States, 48066
        • Comprehensive Urology
      • Troy, Michigan, United States, 48084
        • Michigan Institute of Urology, PC
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Mississippi
      • Southaven, Mississippi, United States, 38671
        • The Urology Group
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Specialty Clinical Research of St. Louis
    • Nevada
      • Reno, Nevada, United States, 89511
        • Urology Nevada
    • New Jersey
      • Morristown, New Jersey, United States, 07962
        • Garden State Urology, LLC- Morristown Medical Center
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers Cancer Institute of New Jersey - Cancer Center
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10016
        • NYU Langone Health
      • New York, New York, United States, 10016
        • Integrated Medical Professionals PLLC
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
      • Stony Brook, New York, United States, 11794
        • Stony Brook University
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
      • Syracuse, New York, United States, 13202
        • Associated Medical Professionals of NY
      • The Bronx, New York, United States, 10461
        • Montefiore Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Cancer Center
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • Urology Group
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center
      • Toledo, Ohio, United States, 43614
        • University of Toledo
    • Oregon
      • Springfield, Oregon, United States, 97477
        • Oregon Urology Insititute
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • MidLantic Urology
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Health Milton S. Hershey Medical Center
      • Lancaster, Pennsylvania, United States, 17604
        • Keystone Urology Specialists
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania - Perelman School of Medicine
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • The Miriam Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Urologic Research Center
      • North Charleston, South Carolina, United States, 29406
        • Lowcountry Urology Clinics
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • The Conrad Pearson Clinic
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, United States, 37209
        • Urology Associates, P.C.
    • Texas
      • Amarillo, Texas, United States, 79106
        • Amarillo Urology Research, LLC
      • Arlington, Texas, United States, 76017
        • Urology Associates of North Texas
      • Austin, Texas, United States, 78745
        • Urology Austin, PLLC
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • Md Anderson Cancer Center
      • Houston, Texas, United States, 77030
        • Houston Methodist Research Institute
      • Houston, Texas, United States, 77030
        • Michael E. DeBakey VA Medical Center
      • Houston, Texas, United States, 77074
        • Houston Metro Urology
      • San Antonio, Texas, United States, 78229
        • UT Health San Antonio
      • San Antonio, Texas, United States, 78229
        • Urology San Antonio PA
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah- Huntsman Cancer Institute
    • Virginia
      • Virginia Beach, Virginia, United States, 23462
        • Urology of Virginia (UVA) - Virginia Beach (Devine-Tidewater Urology)
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center
      • Seattle, Washington, United States, 98101
        • Benaroya Research Institute at Virginia Mason
      • Spokane, Washington, United States, 99202
        • Spokane Urology- Southside
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Charleston Area Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin Medical Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cretostimogene after TURBT
Following screening confirmation of IR-NMIBC and complete resection of the tumor, participants will be treated with adjuvant cretostimogene.
Drug: Cretostimogene Grenadenorepvec
Engineered Oncolytic Adenovirus
Other Names:
  • CG0070
Other: n-dodecyl-B-D-maltoside
Transduction-enhancing agent
Other Names:
  • DDM
No Intervention: Observation after TURBT

Following screening confirmation of IR-NMIBC and complete resection of tumor, participants will enter surveillance.

Participants who recur with IR-NMIBC after TURBT and surveillance will be offered treatment with cretostimogene as per the treatment schedule in Arm A. This arm will be called the Extension Arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence Free Survival (RFS)
Time Frame: 29 months
Recurrence free survival (RFS) of cretostimogene after TURBT versus surveillance after TURBT
29 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence Free Survival (RFS) at 6 months, 12 months and 24 months
Time Frame: 27 months (RFS at 6 months), 33 months (RFS at 12 months) and 45 months (RFS at 24 months)
Recurrence free survival (RFS) of cretostimogene after TURBT versus surveillance after TURBT at 12 months and 24 months
27 months (RFS at 6 months), 33 months (RFS at 12 months) and 45 months (RFS at 24 months)
Incidence of Adverse Events
Time Frame: 34 months
Safety of cretostimogene following TURBT
34 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CG Oncology, Inc.

Investigators

  • Principal Investigator: Max Kates, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

October 25, 2023

First Submitted That Met QC Criteria

October 30, 2023

First Posted (Actual)

November 1, 2023

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIVOT-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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