ACTIVE_NOT_RECRUITING

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

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Conditions

Non Muscle Invasive Bladder CancerUrologic CancerBladder CancerUrothelial CarcinomaUrologyIntermediate Risk Non Muscle Invasive Bladder CancerCretostimogene Grenadenorepvec

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2023-12-14
Study Completion:2030-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06111235

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pathologically confirmed IR-NMIBC, per American Urologic Association/Society of Urologic Oncology/National Comprehensive Cancer Network guidelines, within 90 days of participant randomization:
  2. 1. Recurrent LG Ta within 12 months of prior LG or HG (HG Ta ≤ 3 cm) tumor
  3. 2. Solitary LG Ta \>3 cm tumor
  4. 3. Multifocal LG Ta tumors
  5. 4. Primary and solitary HG Ta ≤3 cm tumor
  6. 5. LG T1 tumor
  7. * All visible disease removed by TURBT within 90 days of study randomization
  8. * Acceptable baseline organ function
  1. * High-risk NMIBC (e.g., HG T1, Recurrent or multifocal HG Ta\>3cm tumor(s), CIS)
  2. * Low-Risk NMIBC (e.g., solitary LG Ta ≤3 cm tumor)
  3. * Disease in the prostatic urethra at any time or in the upper genitourinary tract within 24 months of randomization
  4. * Muscle-invasive bladder cancer, locally advanced or metastatic bladder cancer
  5. * Prior treatment with any human adenovirus serotype 5 based therapy (e.g., Adstiladrin)

Contacts and Locations

Principal Investigator

Robert Svatek, MD
PRINCIPAL_INVESTIGATOR
University of Texas Health Science Center San Antonio

Study Locations (Sites)

Urology Centers of Alabama PC
Homewood, Alabama, 35209
United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
United States
Mayo Clinic
Scottsdale, Arizona, 85259
United States
Arizona Institute of Urology PLLC
Tucson, Arizona, 85745
United States
Arkansas Urology PA
Little Rock, Arkansas, 72211
United States
Michael G. Oefelein MD Clinical Trials
Bakersfield, California, 93301-2284
United States
USC/Keck Department of Urology
Los Angeles, California, 90033
United States
Tower Urology
Los Angeles, California, 90048
United States
Sun Kim Urology
Orange, California, 92868
United States
University of California Irvine Medical Center (UCIMC)
Orange, California, 92868
United States
University of California Davis Cancer Center
Sacramento, California, 95817
United States
Stanford University School of Medicine
Stanford, California, 94305
United States
Colorado Clinical Research
Aurora, Colorado, 80012
United States
Urology Associates, PC
Lone Tree, Colorado, 80124
United States
Hartford HealthCare Medical Group
Hartford, Connecticut, 06106
United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
United States
Advanced Urology Institute
Daytona Beach, Florida, 32114
United States
Mayo Clinic Cancer Center
Jacksonville, Florida, 32224
United States
Lakeland Regional Health
Lakeland, Florida, 33805
United States
Advanced Urology Institute, LLC
Largo, Florida, 33771
United States
University of Miami
Miami, Florida, 33136
United States
Emory Winship Cancer Center
Atlanta, Georgia, 30322
United States
Velocity Clinical Research- Savanah Urological Associates
Savannah, Georgia, 31405
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
University of Chicago
Chicago, Illinois, 60637
United States
UroPartners LLC
Glenview, Illinois, 60026
United States
Duly Health and Care
Lisle, Illinois, 601152
United States
Urology of Indiana, LLC
Carmel, Indiana, 46032
United States
Urology of Indiana
Greenwood, Indiana, 46143
United States
Urology Center of Iowa Research
West Des Moines, Iowa, 50266
United States
The University of Kansas Cancer Center
Westwood, Kansas, 66205
United States
Wichita Urology Group
Wichita, Kansas, 67226
United States
First Urology, PSC
Louisville, Kentucky, 47130
United States
Southern Urology
Lafayette, Louisiana, 70508
United States
Regional Urology, LLC
Shreveport, Louisiana, 71106
United States
Chesapeake Urology Associates, LLC
Baltimore, Maryland, 21204
United States
Johns Hopkins Hospital Green Spring Station
Baltimore, Maryland, 21287
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02215
United States
Cancer Center at Beth Israel Deaconess Medical Center - Research
Boston, Massachusetts, 02215
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Comprehensive Urology
Roseville, Michigan, 48066
United States
Michigan Institute of Urology, PC
Troy, Michigan, 48084
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
The Urology Group
Southaven, Mississippi, 38671
United States
Objective Health - Specialty Clinical Research of St. Louis
St Louis, Missouri, 63141
United States
Urology Nevada
Reno, Nevada, 89511
United States
Garden State Urology, LLC- Morristown Medical Center
Morristown, New Jersey, 07962
United States
Rutgers Cancer Institute of New Jersey - Cancer Center
New Brunswick, New Jersey, 08901
United States
Integrated Medical Professionals PLLC
New York, New York, 10016
United States
NYU Langone Health
New York, New York, 10016
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
University of Rochester Medical Center
Rochester, New York, 14642
United States
Stony Brook University
Stony Brook, New York, 11794
United States
Associated Medical Professionals of NY
Syracuse, New York, 13202
United States
SUNY Upstate Medical University
Syracuse, New York, 13210
United States
Montefiore Medical Center
The Bronx, New York, 10461
United States
Duke Cancer Center
Durham, North Carolina, 27710
United States
Urology Group
Cincinnati, Ohio, 45212
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States
University of Toledo
Toledo, Ohio, 43614
United States
Oregon Urology Insititute
Springfield, Oregon, 97477
United States
Midlantic Urology
Bala-Cynwyd, Pennsylvania, 19004
United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
Keystone Urology Specialists
Lancaster, Pennsylvania, 17604
United States
University of Pennsylvania - Perelman School of Medicine
Philadelphia, Pennsylvania, 19104
United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States
The Miriam Hospital
Providence, Rhode Island, 02905
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
United States
Lowcountry Urology Clinics
North Charleston, South Carolina, 29406
United States
The Conrad Pearson Clinic
Germantown, Tennessee, 38138
United States
Urology Associates, P.C.
Nashville, Tennessee, 37209
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Amarillo Urology Research, LLC
Amarillo, Texas, 79106
United States
Urology Associates of North Texas
Arlington, Texas, 76017
United States
Urology Austin, PLLC
Austin, Texas, 78745
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
Houston Methodist Research Institute
Houston, Texas, 77030
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
United States
Houston Metro Urology
Houston, Texas, 77074
United States
Urology San Antonio PA
San Antonio, Texas, 78229
United States
UT Health San Antonio
San Antonio, Texas, 78229
United States
University of Utah- Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
Urology of Virginia (UVA) - Virginia Beach (Devine-Tidewater Urology)
Virginia Beach, Virginia, 23462
United States
Benaroya Research Institute at Virginia Mason
Seattle, Washington, 98101
United States
University of Washington Medical Center
Seattle, Washington, 98195
United States
Spokane Urology- Southside
Spokane, Washington, 99202
United States
Charleston Area Medical Center
Charleston, West Virginia, 25304
United States
University of Wisconsin Medical Foundation
Madison, Wisconsin, 53705
United States

Collaborators and Investigators

Sponsor: CG Oncology, Inc.

  • Robert Svatek, MD, PRINCIPAL_INVESTIGATOR, University of Texas Health Science Center San Antonio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-14
Study Completion Date2030-01

Study Record Updates

Study Start Date2023-12-14
Study Completion Date2030-01

Terms related to this study

Keywords Provided by Researchers

  • Urology
  • Bladder Cancer
  • Non Muscle Invasive Bladder Cancer
  • Intermediate Risk Non Muscle Invasive Bladder Cancer
  • Cretostimogene Grenadenorepvec

Additional Relevant MeSH Terms

  • Non Muscle Invasive Bladder Cancer
  • Urologic Cancer
  • Bladder Cancer
  • Urothelial Carcinoma