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Clinical Trials in Canada / NCT06111235
Active, not recruiting Phase 3

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

NCT06111235 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2023-12-14
Last updated
2026-07-01

Condition(s) studied

Non Muscle Invasive Bladder CancerUrologic CancerBladder CancerUrothelial Carcinoma

Investigational drug(s) / intervention(s)

Cretostimogene Grenadenorepvec →n-dodecyl-B-D-maltoside

Cretostimogene Grenadenorepvec: Engineered Oncolytic Adenovirus

n-dodecyl-B-D-maltoside: Transduction-enhancing agent

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Pathologically confirmed IR-NMIBC, per American Urologic Association/Society of Urologic Oncology/National Comprehensive Cancer Network guidelines, within 90 days of participant randomization: 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: * 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)

Primary outcome measure(s)

Trial sites (95)

FacilityCityRegionStatus
Urology Centers of Alabama PC Homewood Alabama
Banner MD Anderson Cancer Center Gilbert Arizona
Mayo Clinic Scottsdale Arizona
Arizona Institute of Urology PLLC Tucson Arizona
Arkansas Urology PA Little Rock Arkansas
Michael G. Oefelein MD Clinical Trials Bakersfield California
USC/Keck Department of Urology Los Angeles California
Tower Urology Los Angeles California
Sun Kim Urology Orange California
University of California Irvine Medical Center (UCIMC) Orange California
University of California Davis Cancer Center Sacramento California
Stanford University School of Medicine Stanford California
Colorado Clinical Research Aurora Colorado
Urology Associates, PC Lone Tree Colorado
Hartford HealthCare Medical Group Hartford Connecticut
MedStar Washington Hospital Center Washington D.C. District of Columbia
Advanced Urology Institute Daytona Beach Florida
Mayo Clinic Cancer Center Jacksonville Florida
Lakeland Regional Health Lakeland Florida
Advanced Urology Institute, LLC Largo Florida
University of Miami Miami Florida
Emory Winship Cancer Center Atlanta Georgia
Velocity Clinical Research- Savanah Urological Associates Savannah Georgia
Rush University Medical Center Chicago Illinois
University of Chicago Chicago Illinois
UroPartners LLC Glenview Illinois
Duly Health and Care Lisle Illinois
Urology of Indiana, LLC Carmel Indiana
Urology of Indiana Greenwood Indiana
Urology Center of Iowa Research West Des Moines Iowa
The University of Kansas Cancer Center Westwood Kansas
Wichita Urology Group Wichita Kansas
First Urology, PSC Louisville Kentucky
Southern Urology Lafayette Louisiana
Regional Urology, LLC Shreveport Louisiana
Chesapeake Urology Associates, LLC Baltimore Maryland
Johns Hopkins Hospital Green Spring Station Baltimore Maryland
Brigham and Women's Hospital Boston Massachusetts
Cancer Center at Beth Israel Deaconess Medical Center - Research Boston Massachusetts
Henry Ford Hospital Detroit Michigan

+ 55 more sites — see the full list on the official registry below.

More CG Oncology, Inc. trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06111235 on ClinicalTrials.gov ↗ ← All trials in Canada