A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT
NCT ID: NCT06111235
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
367 participants
INTERVENTIONAL
2023-12-14
2029-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cretostimogene after TURBT
Following screening confirmation of IR-NMIBC and complete resection of the tumor, participants will be treated with adjuvant cretostimogene.
Cretostimogene Grenadenorepvec
Engineered Oncolytic Adenovirus
n-dodecyl-B-D-maltoside
Transduction-enhancing agent
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.
No interventions assigned to this group
Interventions
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Cretostimogene Grenadenorepvec
Engineered Oncolytic Adenovirus
n-dodecyl-B-D-maltoside
Transduction-enhancing agent
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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)
18 Years
ALL
No
Sponsors
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CG Oncology, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Max Kates, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Urology Centers of Alabama PC
Homewood, Alabama, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Mayo Clinic
Scottsdale, Arizona, United States
Arizona Institute of Urology PLLC
Tucson, Arizona, United States
Arkansas Urology PA
Little Rock, Arkansas, United States
Michael G. Oefelein MD Clinical Trials
Bakersfield, California, United States
USC/Keck Department of Urology
Los Angeles, California, United States
Tower Urology
Los Angeles, California, United States
Sun Kim Urology
Orange, California, United States
University of California Irvine Medical Center (UCIMC)
Orange, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
Stanford University School of Medicine
Stanford, California, United States
Colorado Clinical Research
Aurora, Colorado, United States
Urology Associates, PC
Lone Tree, Colorado, United States
Hartford HealthCare Medical Group
Hartford, Connecticut, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Advanced Urology Institute
Daytona Beach, Florida, United States
Mayo Clinic Cancer Center
Jacksonville, Florida, United States
Lakeland Regional Health
Lakeland, Florida, United States
Advanced Urology Institute, LLC
Largo, Florida, United States
University of Miami
Miami, Florida, United States
Emory Winship Cancer Center
Atlanta, Georgia, United States
Velocity Clinical Research- Savanah Urological Associates
Savannah, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
UroPartners LLC
Glenview, Illinois, United States
Duly Health and Care
Lisle, Illinois, United States
Urology of Indiana, LLC
Carmel, Indiana, United States
Urology of Indiana
Greenwood, Indiana, United States
Urology Center of Iowa Research
West Des Moines, Iowa, United States
The University of Kansas Cancer Center
Westwood, Kansas, United States
Wichita Urology Group
Wichita, Kansas, United States
First Urology, PSC
Louisville, Kentucky, United States
Southern Urology
Lafayette, Louisiana, United States
Regional Urology, LLC
Shreveport, Louisiana, United States
Chesapeake Urology Associates, LLC
Baltimore, Maryland, United States
Johns Hopkins Hospital Green Spring Station
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Cancer Center at Beth Israel Deaconess Medical Center - Research
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Comprehensive Urology
Roseville, Michigan, United States
Michigan Institute of Urology, PC
Troy, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
The Urology Group
Southaven, Mississippi, United States
Specialty Clinical Research of St. Louis
St Louis, Missouri, United States
Urology Nevada
Reno, Nevada, United States
Garden State Urology, LLC- Morristown Medical Center
Morristown, New Jersey, United States
Rutgers Cancer Institute of New Jersey - Cancer Center
New Brunswick, New Jersey, United States
Integrated Medical Professionals PLLC
New York, New York, United States
NYU Langone Health
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Stony Brook University
Stony Brook, New York, United States
Associated Medical Professionals of NY
Syracuse, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke Cancer Center
Durham, North Carolina, United States
Urology Group
Cincinnati, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
University of Toledo
Toledo, Ohio, United States
Oregon Urology Insititute
Springfield, Oregon, United States
Midlantic Urology
Bala-Cynwyd, Pennsylvania, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Keystone Urology Specialists
Lancaster, Pennsylvania, United States
University of Pennsylvania - Perelman School of Medicine
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
The Miriam Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Lowcountry Urology Clinics
North Charleston, South Carolina, United States
The Conrad Pearson Clinic
Germantown, Tennessee, United States
Urology Associates, P.C.
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Amarillo Urology Research, LLC
Amarillo, Texas, United States
Urology Associates of North Texas
Arlington, Texas, United States
Urology Austin, PLLC
Austin, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Houston Methodist Research Institute
Houston, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Michael E. DeBakey VA Medical Center
Houston, Texas, United States
Houston Metro Urology
Houston, Texas, United States
Urology San Antonio PA
San Antonio, Texas, United States
UT Health San Antonio
San Antonio, Texas, United States
University of Utah- Huntsman Cancer Institute
Salt Lake City, Utah, United States
Urology of Virginia (UVA) - Virginia Beach (Devine-Tidewater Urology)
Virginia Beach, Virginia, United States
Benaroya Research Institute at Virginia Mason
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Spokane Urology- Southside
Spokane, Washington, United States
Charleston Area Medical Center
Charleston, West Virginia, United States
University of Wisconsin Medical Foundation
Madison, Wisconsin, United States
Vancouver Prostate Centre
Vancouver, British Columbia, Canada
Nova Scotia Health Centre of Applied Urology Research
Halifax, Nova Scotia, Canada
London Health Sciences Centre
London, Ontario, Canada
University Health Network (UHN) - Princess Margaret Cancer Centre
Toronto, Ontario, Canada
McGill University Health Center - Montreal General Hospital
Montreal, Quebec, Canada
Countries
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References
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Chang SS, Boorjian SA, Chou R, Clark PE, Daneshmand S, Konety BR, Pruthi R, Quale DZ, Ritch CR, Seigne JD, Skinner EC, Smith ND, McKiernan JM. Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline. J Urol. 2016 Oct;196(4):1021-9. doi: 10.1016/j.juro.2016.06.049. Epub 2016 Jun 16.
Related Links
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NCCN Guidelines Bladder Cancer 3.2023
Other Identifiers
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PIVOT-006
Identifier Type: -
Identifier Source: org_study_id
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