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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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 12 weeks 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., Ad-interferon or Adstiladrin)

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT followed by adjuvant cretostimogene versus TURBT alone for the treatment of participants with IR-NMIBC
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cretostimogene after TURBT 		Following screening confirmation of IR-NMIBC and complete resection of the tumor, participants will be treated with adjuvant cretostimogene.
  • Drug: Cretostimogene Grenadenorepvec
    Engineered Oncolytic Adenovirus
    Other names:
    • CG0070
  • Other: n-dodecyl-B-D-maltoside
    Transduction-enhancing agent
    Other names:
    • DDM
No Intervention
Observation after TURBT 		Following screening confirmation of IR-NMIBC and complete resection of tumor, participants will enter observation. Participants who recur with IR-NMIBC after TURBT and observation will be offered treatment with cretostimogene as per the treatment schedule in Arm A. This arm will be called the Extension Arm.

Recruiting Locations

Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
Contact:
Holly Bowen

Mayo Clinic
Scottsdale, Arizona 85259
Contact:
Kae Kaczmarski

Arizona Institute of Urology PLLC
Tucson, Arizona 85745
Contact:
Andrea Navarrette

Arkansas Urology PA
Little Rock, Arkansas 72211
Contact:
Katie O'Brien

Michael G. Oefelein MD Clinical Trials
Bakersfield, California 93301-2284
Contact:
Evelyn De La Cruz

USC/Keck Department of Urology
Los Angeles, California 90033
Contact:
Qingru Feng

Tower Urology
Los Angeles, California 90048
Contact:
Shiblee Nomanee

Sun Kim Urology
Orange, California 92868
Contact:
Tam Le

University of California Irvine Medical Center (UCIMC)
Orange, California 92868
Contact:
Phillip Duffy

University of California Davis Cancer Center
Sacramento, California 95817
Contact:
Jasmeet Bhullar

Stanford University School of Medicine
Stanford, California 94305
Contact:
Kristine Talavera
650-723-0525
kriscima@stanford.edu

Colorado Clinical Research
Aurora, Colorado 80012
Contact:
Deborah Aggers

Urology Associates, PC
Lone Tree, Colorado 80124
Contact:
Bradley Gord

MedStar Washington Hospital Center
Washington, District of Columbia 20010
Contact:
Gilbert Horst

Advanced Urology Institute
Daytona Beach, Florida 32114
Contact:
Sara Esposito
386-236-2676
sara.esposito@auihealth.com

Mayo Clinic Cancer Center
Jacksonville, Florida 32224
Contact:
Maria Prendergast

Lakeland Regional Health
Lakeland, Florida 33805
Contact:
Maczko Bridget

Advanced Urology Institute, LLC
Largo, Florida 33771
Contact:
Amy Franklin

University of Miami
Miami, Florida 33136
Contact:
Bianca Tercero

Emory Winship Cancer Center
Atlanta, Georgia 30322
Contact:
Sierra Williams
404-712-7854
sierra.williams@emory.edu

Velocity Clinical Research- Savanah Urological Associates
Savannah, Georgia 31405
Contact:
Jamie Hill

Rush University Medical Center
Chicago, Illinois 60612
Contact:
Anna Alecci

UroPartners LLC
Glenview, Illinois 60026
Contact:
Karolina Webb
708-273-3737
kwebb@uropartners.com

Duly Health and Care
Lisle, Illinois 601152
Contact:
Theresa Campos

Urology of Indiana, LLC
Carmel, Indiana 46032
Contact:
Sarah Faisal
315-478-4185
sfaisal@ampofny.com

Urology of Indiana
Greenwood, Indiana 46143
Contact:
Sarah Faisal

Urology Center of Iowa Research
West Des Moines, Iowa 50266
Contact:
Jessica Mann

Wichita Urology Group
Wichita, Kansas 67226
Contact:
Tyler Gentry

First Urology, PSC
Louisville, Kentucky 47130
Contact:
Samantha Taylor

Southern Urology
Lafayette, Louisiana 70508
Contact:
Wilson Simmons

Chesapeake Urology Associates, LLC
Baltimore, Maryland 21204
Contact:
Chastity Berry

Johns Hopkins Hospital Green Spring Station
Baltimore, Maryland 21287
Contact:
Tina Wlajnitz

Brigham and Women's Hospital
Boston, Massachusetts 02215
Contact:
Siline Thai

Cancer Center at Beth Israel Deaconess Medical Center - Research
Boston, Massachusetts 02215
Contact:
Victoria Faustin

Michigan Institute of Urology, PC
Troy, Michigan 48084
Contact:
Danielle Osterhout

Mayo Clinic
Rochester, Minnesota 55905
Contact:
Katie Barthels

The Urology Group
Southaven, Mississippi 38671
Contact:
Trina Watson

Objective Health - Specialty Clinical Research of St. Louis
Saint Louis, Missouri 63141
Contact:
Sheila Hamilton

Urology Nevada
Reno, Nevada 89511
Contact:
Jennifer Becker
775-829-5707
jbecker@urologynevada.com

Garden State Urology, LLC- Morristown Medical Center
Morristown, New Jersey 07962
Contact:
Kathryn Radler

Rutgers Cancer Institute of New Jersey - Cancer Center
New Brunswick, New Jersey 08901
Contact:
Alicia Moore

Montefiore Medical Center
Bronx, New York 10461
Contact:
Andrea Asencio

Integrated Medical Professionals PLLC
New York, New York 10016
Contact:
Michael Yang

NYU Langone Health
New York, New York 10016
Contact:
Ari Sysimaki

Icahn School of Medicine at Mount Sinai
New York, New York 10029
Contact:
Sagar Shah

University of Rochester Medical Center
Rochester, New York 14642
Contact:
Austin Jackson

Stony Brook University
Stony Brook, New York 11794
Contact:
Catherine Izzo

Associated Medical Professionals of NY
Syracuse, New York 13202
Contact:
Sarah Faisal

SUNY Upstate Medical University
Syracuse, New York 13210
Contact:
Nicholas Carusone
carusonn@upstate.edu

Duke Cancer Center
Durham, North Carolina 27710
Contact:
Whitney Franz

Urology Group
Cincinnati, Ohio 45212
Contact:
Julie Sebastian

Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
Contact:
Kayla Hamm

University of Toledo
Toledo, Ohio 43614
Contact:
Christina Sattler

Oregon Urology Insititute
Springfield, Oregon 97477
Contact:
Maxim DiMarco

Midlantic Urology
Bala-Cynwyd, Pennsylvania 19004
Contact:
Catherine Frye

Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033
Contact:
Seyma Demirsoy
717-531-1053
sdemirsoy@pennstatehealth.psu.edu

Keystone Urology Specialists
Lancaster, Pennsylvania 17604
Contact:
Kristina Baker

University of Pennsylvania - Perelman School of Medicine
Philadelphia, Pennsylvania 19104
Contact:
Dylan Kolman

Thomas Jefferson University
Philadelphia, Pennsylvania 19107
Contact:
Oleksandr (Alex) Kolesnikov

Medical University of South Carolina
Charleston, South Carolina 29425
Contact:
Renee Tucker

Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
Contact:
Jessica Richardson

Lowcountry Urology Clinics
North Charleston, South Carolina 29406
Contact:
Samara Grimes

The Conrad Pearson Clinic
Germantown, Tennessee 38138
Contact:
Russell Grigsby

Urology Associates, P.C.
Nashville, Tennessee 37209
Contact:
Joe Wallace

Vanderbilt University Medical Center
Nashville, Tennessee 37232
Contact:
Darlene Hancock

Amarillo Urology Research, LLC
Amarillo, Texas 79106
Contact:
Jennifer Gillespie

Urology Associates of North Texas
Arlington, Texas 76017
Contact:
Grace Yoon

Urology Austin, PLLC
Austin, Texas 78745
Contact:
Cecilia Moreno

Houston Methodist Research Institute
Houston, Texas 77030
Contact:
Sejal Dave
sdave@houstonmethodist.org

MD Anderson Cancer Center
Houston, Texas 77030
Contact:
Marisa Lozano

Michael E. DeBakey VA Medical Center
Houston, Texas 77030
Contact:
Thuy Pham

Houston Metro Urology
Houston, Texas 77074
Contact:
Johanna Villamizar

Urology San Antonio PA
San Antonio, Texas 78229
Contact:
Gavon T Payne

UT Health San Antonio
San Antonio, Texas 78229
Contact:
Austen Clark

University of Utah- Huntsman Cancer Institute
Salt Lake City, Utah 84112
Contact:
Susan Sharry

Urology of Virginia (UVA) - Virginia Beach (Devine-Tidewater Urology)
Virginia Beach, Virginia 23462
Contact:
James Knight

Benaroya Research Institute at Virginia Mason
Seattle, Washington 98101
Contact:
Rachel Dowty

University of Washington Medical Center
Seattle, Washington 98195
Contact:
CHORD Research

Spokane Urology- Southside
Spokane, Washington 99202
Contact:
Amy Bardwell

Charleston Area Medical Center
Charleston, West Virginia 25304
Contact:
Jordan Campanelli

More Details

NCT ID
NCT06111235
Status
Recruiting
Sponsor
CG Oncology, Inc.

Study Contact

Shelly Basye, MD
949-409-3700
Recruitment@cgoncology.com

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.

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