A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT
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)
1 other identifier
interventional
367
2 countries
95
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2023
Longer than P75 for phase_3
95 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2023
CompletedFirst Posted
Study publicly available on registry
November 1, 2023
CompletedStudy Start
First participant enrolled
December 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2029
January 12, 2026
January 1, 2026
2.5 years
October 25, 2023
January 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence Free Survival (RFS)
Recurrence free survival (RFS) of cretostimogene after TURBT versus surveillance after TURBT
29 months
Secondary Outcomes (2)
Recurrence Free Survival (RFS) at 6 months, 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
34 months
Study Arms (2)
Cretostimogene after TURBT
EXPERIMENTALFollowing screening confirmation of IR-NMIBC and complete resection of the tumor, participants will be treated with adjuvant cretostimogene.
Observation after TURBT
NO INTERVENTIONFollowing 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.
Interventions
Engineered Oncolytic Adenovirus
Transduction-enhancing agent
Eligibility Criteria
You may qualify if:
- Pathologically confirmed IR-NMIBC, per American Urologic Association/Society of Urologic Oncology/National Comprehensive Cancer Network guidelines, within 90 days of participant randomization:
- Recurrent LG Ta within 12 months of prior LG or HG (HG Ta ≤ 3 cm) tumor
- Solitary LG Ta \>3 cm tumor
- Multifocal LG Ta tumors
- Primary and solitary HG Ta ≤3 cm tumor
- LG T1 tumor
- All visible disease removed by TURBT within 90 days of study randomization
- Acceptable baseline organ function
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (95)
Urology Centers of Alabama PC
Homewood, Alabama, 35209, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Mayo Clinic
Scottsdale, Arizona, 85259, United States
Arizona Institute of Urology PLLC
Tucson, Arizona, 85745, United States
Arkansas Urology PA
Little Rock, Arkansas, 72211, United States
Michael G. Oefelein MD Clinical Trials
Bakersfield, California, 93301-2284, United States
USC/Keck Department of Urology
Los Angeles, California, 90033, United States
Tower Urology
Los Angeles, California, 90048, United States
Sun Kim Urology
Orange, California, 92868, United States
University of California Irvine Medical Center (UCIMC)
Orange, California, 92868, United States
University of California Davis Cancer Center
Sacramento, California, 95817, United States
Stanford University School of Medicine
Stanford, California, 94305, United States
Colorado Clinical Research
Aurora, Colorado, 80012, United States
Urology Associates, PC
Lone Tree, Colorado, 80124, United States
Hartford HealthCare Medical Group
Hartford, Connecticut, 06106, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Advanced Urology Institute
Daytona Beach, Florida, 32114, United States
Mayo Clinic Cancer Center
Jacksonville, Florida, 32224, United States
Lakeland Regional Health
Lakeland, Florida, 33805, United States
Advanced Urology Institute, LLC
Largo, Florida, 33771, United States
University of Miami
Miami, Florida, 33136, United States
Emory Winship Cancer Center
Atlanta, Georgia, 30322, United States
Velocity Clinical Research- Savanah Urological Associates
Savannah, Georgia, 31405, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Chicago
Chicago, Illinois, 60637, United States
UroPartners LLC
Glenview, Illinois, 60026, United States
Duly Health and Care
Lisle, Illinois, 601152, United States
Urology of Indiana, LLC
Carmel, Indiana, 46032, United States
Urology of Indiana
Greenwood, Indiana, 46143, United States
Urology Center of Iowa Research
West Des Moines, Iowa, 50266, United States
The University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
Wichita Urology Group
Wichita, Kansas, 67226, United States
First Urology, PSC
Louisville, Kentucky, 47130, United States
Southern Urology
Lafayette, Louisiana, 70508, United States
Regional Urology, LLC
Shreveport, Louisiana, 71106, United States
Chesapeake Urology Associates, LLC
Baltimore, Maryland, 21204, United States
Johns Hopkins Hospital Green Spring Station
Baltimore, Maryland, 21287, 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
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Comprehensive Urology
Roseville, Michigan, 48066, United States
Michigan Institute of Urology, PC
Troy, Michigan, 48084, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
The Urology Group
Southaven, Mississippi, 38671, United States
Specialty Clinical Research of St. Louis
St Louis, Missouri, 63141, United States
Urology Nevada
Reno, Nevada, 89511, United States
Garden State Urology, LLC- Morristown Medical Center
Morristown, New Jersey, 07962, United States
Rutgers Cancer Institute of New Jersey - Cancer Center
New Brunswick, New Jersey, 08901, United States
Integrated Medical Professionals PLLC
New York, New York, 10016, United States
NYU Langone Health
New York, New York, 10016, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Stony Brook University
Stony Brook, New York, 11794, United States
Associated Medical Professionals of NY
Syracuse, New York, 13202, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Duke Cancer Center
Durham, North Carolina, 27710, United States
Urology Group
Cincinnati, Ohio, 45212, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
University of Toledo
Toledo, Ohio, 43614, United States
Oregon Urology Insititute
Springfield, Oregon, 97477, United States
Midlantic Urology
Bala-Cynwyd, Pennsylvania, 19004, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Keystone Urology Specialists
Lancaster, Pennsylvania, 17604, United States
University of Pennsylvania - Perelman School of Medicine
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
The Miriam Hospital
Providence, Rhode Island, 02905, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
Lowcountry Urology Clinics
North Charleston, South Carolina, 29406, United States
The Conrad Pearson Clinic
Germantown, Tennessee, 38138, United States
Urology Associates, P.C.
Nashville, Tennessee, 37209, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Amarillo Urology Research, LLC
Amarillo, Texas, 79106, United States
Urology Associates of North Texas
Arlington, Texas, 76017, United States
Urology Austin, PLLC
Austin, Texas, 78745, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Houston Methodist Research Institute
Houston, Texas, 77030, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030, United States
Houston Metro Urology
Houston, Texas, 77074, United States
Urology San Antonio PA
San Antonio, Texas, 78229, United States
UT Health San Antonio
San Antonio, Texas, 78229, United States
University of Utah- Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Urology of Virginia (UVA) - Virginia Beach (Devine-Tidewater Urology)
Virginia Beach, Virginia, 23462, United States
Benaroya Research Institute at Virginia Mason
Seattle, Washington, 98101, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Spokane Urology- Southside
Spokane, Washington, 99202, United States
Charleston Area Medical Center
Charleston, West Virginia, 25304, United States
University of Wisconsin Medical Foundation
Madison, Wisconsin, 53705, United States
Vancouver Prostate Centre
Vancouver, British Columbia, V5Z 1M9, Canada
Nova Scotia Health Centre of Applied Urology Research
Halifax, Nova Scotia, B3H 2Y9, Canada
London Health Sciences Centre
London, Ontario, N6A 5W9, Canada
University Health Network (UHN) - Princess Margaret Cancer Centre
Toronto, Ontario, M5G 1Z5, Canada
McGill University Health Center - Montreal General Hospital
Montreal, Quebec, H4A 3J1, Canada
Related Publications (1)
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.
PMID: 27317986BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Max Kates, MD
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2023
First Posted
November 1, 2023
Study Start
December 14, 2023
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
February 1, 2029
Last Updated
January 12, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share