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

Running, not enrolling · Phase 3

Conditions studied: Non Muscle Invasive Bladder Cancer, Urologic Cancer, Bladder Cancer, Urothelial Carcinoma

In brief

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.

Key facts

Study ID

NCT06111235

Run by

CG Oncology, Inc.

People needed

367

Starts

2023-12-14

Expected to finish

2029-02-01

Last updated by the study team

2026-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• 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
• Urology Centers of Alabama PC — Homewood, Alabama, United States

Full record on ClinicalTrials.gov

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