NCT06111235Active, not recruitingPhase 3
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)
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 367 (actual)
- First submitted
- 25 Oct 2023
- Start date
- 14 Dec 2023
- Primary completion date
- Nov 2026
- Lead sponsor
- CG Oncology, Inc.
- Diseases
- Bladder cancer
- NCT number
- NCT06111235
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 367
- From 14 Dec 2023 to the primary completion date, Nov 2026
- 95 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with any human adenovirus serotype 5 based therapy (e.g., Adstiladrin)
Other illness
- 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
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (95)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nova Scotia Health Centre of Applied Urology Research Coordinator of this site? Confirm its status | Halifax | Canada | Unknown status |
| London Health Sciences Centre Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| McGill University Health Center - Montreal General Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| University Health Network UHN Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Vancouver Prostate Centre Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Amarillo Urology Research, LLC Coordinator of this site? Confirm its status | Amarillo | United States | Unknown status |
| Urology Associates of North Texas Coordinator of this site? Confirm its status | Arlington | United States | Unknown status |
| Emory Winship Cancer Center Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Colorado Clinical Research Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Urology Austin PLLC Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Michael G Oefelein, MD Clinical Trials Coordinator of this site? Confirm its status | Bakersfield | United States | Unknown status |
| MidLantic Urology Coordinator of this site? Confirm its status | Bala-Cynwyd | United States | Unknown status |
| Chesapeake Urology Associates, LLC Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Johns Hopkins Hospital Green Spring Station Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Cancer Center at Beth Israel Deaconess Medical Center - Research Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Urology of Indiana, LLC Coordinator of this site? Confirm its status | Carmel | United States | Unknown status |
| Charleston Area Medical Center Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Rush University Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Urology Group Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Ohio State University Comprehensive Cancer Center Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Advanced Urology Institute Coordinator of this site? Confirm its status | Daytona Beach | United States | Unknown status |
| Henry Ford Hospital Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Duke Cancer Center Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| The Conrad Pearson Clinic Coordinator of this site? Confirm its status | Germantown | United States | Unknown status |
| Banner MD Anderson Cancer Center Coordinator of this site? Confirm its status | Gilbert | United States | Unknown status |
| UroPartners LLC Coordinator of this site? Confirm its status | Glenview | United States | Unknown status |
| Urology of Indiana Coordinator of this site? Confirm its status | Greenwood | United States | Unknown status |
| Hartford HealthCare Medical Group Coordinator of this site? Confirm its status | Hartford | United States | Unknown status |
| Penn State Health Milton S. Hershey Medical Center Coordinator of this site? Confirm its status | Hershey | United States | Unknown status |
| Urology Centers Of Alabama Pc Coordinator of this site? Confirm its status | Homewood | United States | Unknown status |
| Houston Metro Urology Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Michael E. DeBakey VA Medical Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Houston Methodist Research Institute Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Mayo Clinic Cancer Center Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Southern Urology Coordinator of this site? Confirm its status | Lafayette | United States | Unknown status |
| Lakeland Regional Health Coordinator of this site? Confirm its status | Lakeland | United States | Unknown status |
| Keystone Urology Specialists Coordinator of this site? Confirm its status | Lancaster | United States | Unknown status |
| Advanced Urology Institute, LLC Coordinator of this site? Confirm its status | Largo | United States | Unknown status |
| Duly Health and Care Coordinator of this site? Confirm its status | Lisle | United States | Unknown status |
| Arkansas Urology PA Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| Urology Associates, PC Coordinator of this site? Confirm its status | Lone Tree | United States | Unknown status |
| USC/Keck Department of Urology Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Tower Urology Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| First Urology, PSC Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| University of Wisconsin Medical Foundation Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Garden State Urology, LLC- Morristown Medical Center Coordinator of this site? Confirm its status | Morristown | United States | Unknown status |
| Carolina Urologic Research Center Coordinator of this site? Confirm its status | Myrtle Beach | United States | Unknown status |
| Urology Associates, P.C. Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Rutgers Cancer Institute of New Jersey - Cancer Center Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Integrated Medical Professionals, PLLC Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Lowcountry Urology Clinics Coordinator of this site? Confirm its status | North Charleston | United States | Unknown status |
| Sun Kim Urology Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| University of California Irvine Medical Center (UCIMC) Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| University of Pennsylvania Perelman School of Medicine Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Thomas Jefferson University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| The Miriam Hospital Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
| Urology Nevada Coordinator of this site? Confirm its status | Reno | United States | Unknown status |
| University of Rochester Medical Center Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Comprehensive Urology Coordinator of this site? Confirm its status | Roseville | United States | Unknown status |
| University of California Davis Cancer Center Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| University of Utah - Huntsman Cancer Institute Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| UT Health San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Urology San Antonio PA Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Velocity Clinical Research- Savanah Urological Associates Coordinator of this site? Confirm its status | Savannah | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| University of Washington Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Benaroya Research Institute at Virginia Mason Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Regional Urology, LLC Coordinator of this site? Confirm its status | Shreveport | United States | Unknown status |
| The Urology Group Coordinator of this site? Confirm its status | Southaven | United States | Unknown status |
| Spokane Urology- Southside Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| Oregon Urology Insititute Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Stanford University School of Medicine Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
| Specialty Clinical Research of St. Louis Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Stony Brook University Coordinator of this site? Confirm its status | Stony Brook | United States | Unknown status |
| Associated Medical Professionals of NY Coordinator of this site? Confirm its status | Syracuse | United States | Unknown status |
| SUNY Upstate Medical University Coordinator of this site? Confirm its status | Syracuse | United States | Unknown status |
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| University of Toledo Coordinator of this site? Confirm its status | Toledo | United States | Unknown status |
| Michigan Institute of Urology, PC Coordinator of this site? Confirm its status | Troy | United States | Unknown status |
| Arizona Institute of Urology, PLLC Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Urology of Virginia (UVA) - Virginia Beach (Devine-Tidewater Urology) Coordinator of this site? Confirm its status | Virginia Beach | United States | Unknown status |
| MedStar Washington Hospital Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Urology Center of Iowa Research Coordinator of this site? Confirm its status | West Des Moines | United States | Unknown status |
| The University of Kansas Cancer Center Coordinator of this site? Confirm its status | Westwood | United States | Unknown status |
| Wichita Urology Group Coordinator of this site? Confirm its status | Wichita | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.