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)
Status: Active_not_recruiting
Location: See all (95) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
Urology Centers of Alabama PC
Homewood
Arkansas
Arkansas Urology PA
Little Rock
Arizona
Banner MD Anderson Cancer Center
Gilbert
Mayo Clinic
Scottsdale
Arizona Institute of Urology PLLC
Tucson
California
Michael G. Oefelein MD Clinical Trials
Bakersfield
Tower Urology
Los Angeles
USC/Keck Department of Urology
Los Angeles
Sun Kim Urology
Orange
University of California Irvine Medical Center (UCIMC)
Orange
University of California Davis Cancer Center
Sacramento
Stanford University School of Medicine
Stanford
Colorado
Colorado Clinical Research
Aurora
Urology Associates, PC
Lone Tree
Connecticut
Hartford HealthCare Medical Group
Hartford
Washington, D.c.
MedStar Washington Hospital Center
Washington D.c.
Florida
Advanced Urology Institute
Daytona Beach
Mayo Clinic Cancer Center
Jacksonville
Lakeland Regional Health
Lakeland
Advanced Urology Institute, LLC
Largo
University of Miami
Miami
Georgia
Emory Winship Cancer Center
Atlanta
Velocity Clinical Research- Savanah Urological Associates
Savannah
Iowa
Urology Center of Iowa Research
West Des Moines
Illinois
Rush University Medical Center
Chicago
University of Chicago
Chicago
UroPartners LLC
Glenview
Duly Health and Care
Lisle
Indiana
Urology of Indiana, LLC
Carmel
Urology of Indiana
Greenwood
Kansas
The University of Kansas Cancer Center
Westwood
Wichita Urology Group
Wichita
Kentucky
First Urology, PSC
Louisville
Louisiana
Southern Urology
Lafayette
Regional Urology, LLC
Shreveport
Massachusetts
Brigham and Women's Hospital
Boston
Cancer Center at Beth Israel Deaconess Medical Center - Research
Boston
Maryland
Chesapeake Urology Associates, LLC
Baltimore
Johns Hopkins Hospital Green Spring Station
Baltimore
Michigan
Henry Ford Hospital
Detroit
Comprehensive Urology
Roseville
Michigan Institute of Urology, PC
Troy
Minnesota
Mayo Clinic
Rochester
Missouri
Objective Health - Specialty Clinical Research of St. Louis
St Louis
Mississippi
The Urology Group
Southaven
North Carolina
Duke Cancer Center
Durham
New Jersey
Garden State Urology, LLC- Morristown Medical Center
Morristown
Rutgers Cancer Institute of New Jersey - Cancer Center
New Brunswick
Nevada
Urology Nevada
Reno
New York
Icahn School of Medicine at Mount Sinai
New York
Integrated Medical Professionals PLLC
New York
NYU Langone Health
New York
University of Rochester Medical Center
Rochester
Stony Brook University
Stony Brook
Associated Medical Professionals of NY
Syracuse
SUNY Upstate Medical University
Syracuse
Montefiore Medical Center
The Bronx
Ohio
Urology Group
Cincinnati
Ohio State University Comprehensive Cancer Center
Columbus
University of Toledo
Toledo
Oregon
Oregon Urology Insititute
Springfield
Pennsylvania
Midlantic Urology
Bala-cynwyd
Penn State Health Milton S. Hershey Medical Center
Hershey
Keystone Urology Specialists
Lancaster
Thomas Jefferson University
Philadelphia
University of Pennsylvania - Perelman School of Medicine
Philadelphia
Rhode Island
The Miriam Hospital
Providence
South Carolina
Medical University of South Carolina
Charleston
Carolina Urologic Research Center
Myrtle Beach
Lowcountry Urology Clinics
North Charleston
Tennessee
The Conrad Pearson Clinic
Germantown
Urology Associates, P.C.
Nashville
Vanderbilt University Medical Center
Nashville
Texas
Amarillo Urology Research, LLC
Amarillo
Urology Associates of North Texas
Arlington
Urology Austin, PLLC
Austin
University of Texas Southwestern Medical Center
Dallas
Houston Methodist Research Institute
Houston
Houston Metro Urology
Houston
MD Anderson Cancer Center
Houston
Michael E. DeBakey VA Medical Center
Houston
Urology San Antonio PA
San Antonio
UT Health San Antonio
San Antonio
Utah
University of Utah- Huntsman Cancer Institute
Salt Lake City
Virginia
Urology of Virginia (UVA) - Virginia Beach (Devine-Tidewater Urology)
Virginia Beach
Washington
Benaroya Research Institute at Virginia Mason
Seattle
University of Washington Medical Center
Seattle
Spokane Urology- Southside
Spokane
Wisconsin
University of Wisconsin Medical Foundation
Madison
West Virginia
Charleston Area Medical Center
Charleston
Other Locations
Canada
Nova Scotia Health Centre of Applied Urology Research
Halifax
London Health Sciences Centre
London
McGill University Health Center - Montreal General Hospital
Montreal
University Health Network (UHN) - Princess Margaret Cancer Centre
Toronto
Vancouver Prostate Centre
Vancouver
Time Frame
Start Date: 2023-12-14
Completion Date: 2030-01
Participants
Target number of participants: 367
Treatments
Experimental: Cretostimogene after TURBT
Following screening confirmation of IR-NMIBC and complete resection of the tumor, participants will be treated with adjuvant cretostimogene.
No_intervention: Observation after TURBT
Following 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.
Related Therapeutic Areas
Sponsors
Leads: CG Oncology, Inc.