A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT
- Conditions
- Urologic CancerNon Muscle Invasive Bladder CancerUrothelial CarcinomaBladder Cancer
- Interventions
- Other: n-dodecyl-B-D-maltoside
- Registration Number
- NCT06111235
- Lead Sponsor
- CG Oncology, Inc.
- 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 observation for the treatment of participants with IR-NMIBC.
- Detailed Description
Participants will be randomized 1:1 to cretostimogene grenadenorepvec after TURBT (Arm A) vs observation 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, complete bladder visualization (e.g., 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.
Participants in Arm B who recur with IR-NMIBC after TURBT and observation will be offered treatment with cretostimogene as per the treatment schedule in Arm A.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 364
-
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 12 weeks of study randomization
-
Acceptable baseline organ function
- 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., Ad-interferon or Adstiladrin)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cretostimogene after TURBT Cretostimogene Grenadenorepvec Following screening confirmation of IR-NMIBC and complete resection of the tumor, participants will be treated with adjuvant cretostimogene. Cretostimogene after TURBT n-dodecyl-B-D-maltoside Following screening confirmation of IR-NMIBC and complete resection of the tumor, participants will be treated with adjuvant cretostimogene.
- Primary Outcome Measures
Name Time Method Recurrence Free Survival (RFS) 51 months Recurrence free survival (RFS) of cretostimogene after TURBT versus observation after TURBT
- Secondary Outcome Measures
Name Time Method Recurrence Free Survival (RFS) at 12 months and 24 months 51 months (RFS at 12 months) and 63 months (RFS at 24 months) Recurrence free survival (RFS) of cretostimogene after TURBT versus observation after TURBT at 12 months and 24 months
Incidence of Adverse Events 52 months Safety of cretostimogene following TURBT
Trial Locations
- Locations (87)
Urology Centers of Alabama PC
🇺🇸Homewood, Alabama, United States
Banner MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, 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, 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
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
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
Michigan Institute of Urology, PC
🇺🇸Troy, Michigan, United States
The Urology Group
🇺🇸Southaven, Mississippi, United States
Objective Health - Specialty Clinical Research of St. Louis
🇺🇸Saint 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
Montefiore Medical Center
🇺🇸Bronx, New York, 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
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
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
London Health Sciences Centre
🇨🇦London, Ontario, Canada
McGill University Health Center - Montreal General Hospital
🇨🇦Montréal, Quebec, Canada