Trial Title:
A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT
NCT ID:
NCT06111235
Condition:
Non Muscle Invasive Bladder Cancer
Urologic Cancer
Bladder Cancer
Urothelial Carcinoma
Conditions: Official terms:
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Urologic Neoplasms
Conditions: Keywords:
Urology
Bladder Cancer
Non Muscle Invasive Bladder Cancer
Intermediate Risk Non Muscle Invasive Bladder Cancer
Cretostimogene Grenadenorepvec
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
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)
Intervention:
Intervention type:
Drug
Intervention name:
Cretostimogene Grenadenorepvec
Description:
Engineered Oncolytic Adenovirus
Arm group label:
Cretostimogene after TURBT
Other name:
CG0070
Intervention type:
Other
Intervention name:
n-dodecyl-B-D-maltoside
Description:
Transduction-enhancing agent
Arm group label:
Cretostimogene after TURBT
Other name:
DDM
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 observation for the
treatment of participants with IR-NMIBC.
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.
Criteria for eligibility:
Criteria:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Banner MD Anderson Cancer Center
Address:
City:
Gilbert
Zip:
85234
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Holly Bowen
Investigator:
Last name:
Chinedu Mmeje, MD
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic
Address:
City:
Scottsdale
Zip:
85259
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kae Kaczmarski
Investigator:
Last name:
Mark Tyson, MD
Email:
Principal Investigator
Facility:
Name:
Arizona Institute of Urology PLLC
Address:
City:
Tucson
Zip:
85745
Country:
United States
Status:
Recruiting
Contact:
Last name:
Andrea Navarrette
Investigator:
Last name:
Kalpesh Patel, MD
Email:
Principal Investigator
Facility:
Name:
Arkansas Urology PA
Address:
City:
Little Rock
Zip:
72211
Country:
United States
Status:
Recruiting
Contact:
Last name:
Katie O'Brien
Investigator:
Last name:
R. Jonathan Henderson, MD
Email:
Principal Investigator
Facility:
Name:
Michael G. Oefelein MD Clinical Trials
Address:
City:
Bakersfield
Zip:
93301-2284
Country:
United States
Status:
Recruiting
Contact:
Last name:
Evelyn De La Cruz
Investigator:
Last name:
Michael Oefelein, MD
Email:
Principal Investigator
Facility:
Name:
USC/Keck Department of Urology
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Qingru Feng
Investigator:
Last name:
Anne Schuckman, MD
Email:
Principal Investigator
Facility:
Name:
Tower Urology
Address:
City:
Los Angeles
Zip:
90048
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shiblee Nomanee
Investigator:
Last name:
David Josephson, MD
Email:
Principal Investigator
Facility:
Name:
Sun Kim Urology
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tam Le
Investigator:
Last name:
Sun Kim, MD
Email:
Principal Investigator
Facility:
Name:
University of California Irvine Medical Center (UCIMC)
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Recruiting
Contact:
Last name:
Phillip Duffy
Investigator:
Last name:
Edward Uchio, MD
Email:
Principal Investigator
Facility:
Name:
University of California Davis Cancer Center
Address:
City:
Sacramento
Zip:
95817
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Jasmeet Bhullar
Investigator:
Last name:
Thenappan Chandrasekar, MD
Email:
Principal Investigator
Facility:
Name:
Stanford University School of Medicine
Address:
City:
Stanford
Zip:
94305
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Kristine Talavera
Phone:
650-723-0525
Email:
kriscima@stanford.edu
Investigator:
Last name:
Eila Skinner, MD
Email:
Principal Investigator
Facility:
Name:
Colorado Clinical Research
Address:
City:
Aurora
Zip:
80012
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Deborah Aggers
Investigator:
Last name:
David Cahn, MD
Email:
Principal Investigator
Facility:
Name:
Urology Associates, PC
Address:
City:
Lone Tree
Zip:
80124
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bradley Gord
Investigator:
Last name:
Bradley Bell, MD
Email:
Principal Investigator
Facility:
Name:
MedStar Washington Hospital Center
Address:
City:
Washington
Zip:
20010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Gilbert Horst
Investigator:
Last name:
Lambros Stamatakis, MD
Email:
Principal Investigator
Facility:
Name:
Advanced Urology Institute
Address:
City:
Daytona Beach
Zip:
32114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sara Esposito
Phone:
386-236-2676
Email:
sara.esposito@auihealth.com
Investigator:
Last name:
Samuel Lawindy, MD
Email:
Principal Investigator
Facility:
Name:
Lakeland Regional Health
Address:
City:
Lakeland
Zip:
33805
Country:
United States
Status:
Recruiting
Contact:
Last name:
Maczko Bridget
Investigator:
Last name:
Peter Hinds, MD
Email:
Principal Investigator
Facility:
Name:
Advanced Urology Institute, LLC
Address:
City:
Largo
Zip:
33771
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amy Franklin
Investigator:
Last name:
Matthew Truesdale, MD
Email:
Principal Investigator
Facility:
Name:
Emory Winship Cancer Center
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Sierra Williams
Phone:
404-712-7854
Email:
sierra.williams@emory.edu
Investigator:
Last name:
Vikram Narayan, MD
Email:
Principal Investigator
Facility:
Name:
Velocity Clinical Research- Savanah Urological Associates
Address:
City:
Savannah
Zip:
31405
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jamie Hill
Investigator:
Last name:
Buffi Boyd, MD
Email:
Principal Investigator
Facility:
Name:
UroPartners LLC
Address:
City:
Glenview
Zip:
60026
Country:
United States
Status:
Recruiting
Contact:
Last name:
Karolina Webb
Phone:
708-273-3737
Email:
kwebb@uropartners.com
Investigator:
Last name:
Jeffrey A Pearl, MD
Email:
Principal Investigator
Facility:
Name:
Duly Health and Care
Address:
City:
Lisle
Zip:
601152
Country:
United States
Status:
Recruiting
Contact:
Last name:
Theresa Campos
Investigator:
Last name:
Ranko Miocinovic, MD
Email:
Principal Investigator
Facility:
Name:
Urology of Indiana, LLC
Address:
City:
Carmel
Zip:
46032
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sarah Faisal
Phone:
315-478-4185
Phone ext:
7794
Email:
sfaisal@ampofny.com
Investigator:
Last name:
Chad Reichard, MD
Email:
Principal Investigator
Facility:
Name:
Urology Center of Iowa Research
Address:
City:
West Des Moines
Zip:
50266
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Jessica Mann
Investigator:
Last name:
Brian Gallagher, MD
Email:
Principal Investigator
Facility:
Name:
Wichita Urology Group
Address:
City:
Wichita
Zip:
67226
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tyler Gentry
Investigator:
Last name:
PHilippe Nabbout, MD
Email:
Principal Investigator
Facility:
Name:
First Urology, PSC
Address:
City:
Louisville
Zip:
47130
Country:
United States
Status:
Recruiting
Contact:
Last name:
Samantha Taylor
Investigator:
Last name:
Ryan Malone, MD
Email:
Principal Investigator
Facility:
Name:
Southern Urology
Address:
City:
Lafayette
Zip:
70508
Country:
United States
Status:
Recruiting
Contact:
Last name:
Wilson Simmons
Investigator:
Last name:
Jason Bourque, MD
Email:
Principal Investigator
Facility:
Name:
Regional Urology, LLC
Address:
City:
Shreveport
Zip:
71106
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kayla Telano
Investigator:
Last name:
David Price, MD
Email:
Principal Investigator
Facility:
Name:
Chesapeake Urology Associates, LLC
Address:
City:
Baltimore
Zip:
21204
Country:
United States
Status:
Recruiting
Contact:
Last name:
Chastity Berry
Investigator:
Last name:
Rian Dickstein, MD
Email:
Principal Investigator
Facility:
Name:
Johns Hopkins Hospital Green Spring Station
Address:
City:
Baltimore
Zip:
21287
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tina Wlajnitz
Investigator:
Last name:
Max Kates, MD
Email:
Principal Investigator
Facility:
Name:
Brigham and Women's Hospital
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Siline Thai
Investigator:
Last name:
Mark Preston, MD
Email:
Principal Investigator
Facility:
Name:
Cancer Center at Beth Israel Deaconess Medical Center - Research
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Victoria Faustin
Investigator:
Last name:
Boris Gershman, MD
Email:
Principal Investigator
Facility:
Name:
Michigan Institute of Urology, PC
Address:
City:
Troy
Zip:
48084
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Danielle Osterhout
Investigator:
Last name:
Jason Hafron, MD
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Katie Barthels
Investigator:
Last name:
Paras Shah, MD
Email:
Principal Investigator
Facility:
Name:
The Urology Group
Address:
City:
Southaven
Zip:
38671
Country:
United States
Status:
Recruiting
Contact:
Last name:
Trina Watson
Investigator:
Last name:
Mark Greenberger, MD
Email:
Principal Investigator
Facility:
Name:
Objective Health - Specialty Clinical Research of St. Louis
Address:
City:
Saint Louis
Zip:
63141
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sheila Hamilton
Investigator:
Last name:
Gregory Auffenberg, MD
Email:
Principal Investigator
Facility:
Name:
Urology Nevada
Address:
City:
Reno
Zip:
89511
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Becker
Phone:
775-829-5707
Email:
jbecker@urologynevada.com
Investigator:
Last name:
Dimitar Zlatev, MD
Email:
Principal Investigator
Facility:
Name:
Garden State Urology, LLC- Morristown Medical Center
Address:
City:
Morristown
Zip:
07962
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Kathryn Radler
Investigator:
Last name:
Sandip Prasad, MD
Email:
Principal Investigator
Facility:
Name:
Rutgers Cancer Institute of New Jersey - Cancer Center
Address:
City:
New Brunswick
Zip:
08901
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alicia Moore
Investigator:
Last name:
Vignesh Packiam, MD
Email:
Principal Investigator
Facility:
Name:
Montefiore Medical Center
Address:
City:
Bronx
Zip:
10461
Country:
United States
Status:
Recruiting
Contact:
Last name:
Andrea Asencio
Investigator:
Last name:
Alexander Sankin, MD
Email:
Principal Investigator
Facility:
Name:
Integrated Medical Professionals PLLC
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michael Yang
Investigator:
Last name:
Jed Kaminetsky, MD
Email:
Principal Investigator
Facility:
Name:
NYU Langone Health
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Ari Sysimaki
Investigator:
Last name:
Katie Murray, DO
Email:
Principal Investigator
Facility:
Name:
University of Rochester Medical Center
Address:
City:
Rochester
Zip:
14642
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Austin Jackson
Investigator:
Last name:
William Tabayoyong, MD
Email:
Principal Investigator
Facility:
Name:
Associated Medical Professionals of NY
Address:
City:
Syracuse
Zip:
13202
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Sarah Faisal
Investigator:
Last name:
Christopher Pieczonka, MD
Email:
Principal Investigator
Facility:
Name:
Duke Cancer Center
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Whitney Franz
Investigator:
Last name:
Ankeet Shah, MD
Email:
Principal Investigator
Facility:
Name:
Urology Group
Address:
City:
Cincinnati
Zip:
45212
Country:
United States
Status:
Recruiting
Contact:
Last name:
Julie Sebastian
Investigator:
Last name:
Marc Pliskin, DO
Email:
Principal Investigator
Facility:
Name:
Oregon Urology Insititute
Address:
City:
Springfield
Zip:
97477
Country:
United States
Status:
Recruiting
Contact:
Last name:
Maxim DiMarco
Investigator:
Last name:
Bryan Mehlhaff, MD
Email:
Principal Investigator
Facility:
Name:
Midlantic Urology
Address:
City:
Bala-Cynwyd
Zip:
19004
Country:
United States
Status:
Recruiting
Contact:
Last name:
Catherine Frye
Investigator:
Last name:
Laurence Belkoff, DO
Email:
Principal Investigator
Facility:
Name:
Penn State Health Milton S. Hershey Medical Center
Address:
City:
Hershey
Zip:
17033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Seyma Demirsoy
Phone:
717-531-1053
Email:
sdemirsoy@pennstatehealth.psu.edu
Investigator:
Last name:
Hong Truong, MD
Email:
Principal Investigator
Facility:
Name:
Keystone Urology Specialists
Address:
City:
Lancaster
Zip:
17604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kristina Baker
Investigator:
Last name:
Paul Sieber, MD
Email:
Principal Investigator
Facility:
Name:
University of Pennsylvania - Perelman School of Medicine
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Dylan Kolman
Investigator:
Last name:
Trinity Bivalacqua, MD
Email:
Principal Investigator
Facility:
Name:
The Miriam Hospital
Address:
City:
Providence
Zip:
02905
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Taylor Braunagel
Investigator:
Last name:
Dragan Golijanin, MD
Email:
Principal Investigator
Facility:
Name:
Medical University of South Carolina
Address:
City:
Charleston
Zip:
29425
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Renee Tucker
Investigator:
Last name:
Robert Grubb, MD
Email:
Principal Investigator
Facility:
Name:
Carolina Urologic Research Center
Address:
City:
Myrtle Beach
Zip:
29572
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jessica Richardson
Investigator:
Last name:
Neal Shore, MD
Email:
Principal Investigator
Facility:
Name:
Lowcountry Urology Clinics
Address:
City:
North Charleston
Zip:
29406
Country:
United States
Status:
Recruiting
Contact:
Last name:
Samara Grimes
Investigator:
Last name:
Justin Ellett, MD
Email:
Principal Investigator
Facility:
Name:
The Conrad Pearson Clinic
Address:
City:
Germantown
Zip:
38138
Country:
United States
Status:
Recruiting
Contact:
Last name:
Russell Grigsby
Investigator:
Last name:
Ravi Chauhan, MD
Email:
Principal Investigator
Facility:
Name:
Urology Associates, P.C.
Address:
City:
Nashville
Zip:
37209
Country:
United States
Status:
Recruiting
Contact:
Last name:
Joe Wallace
Investigator:
Last name:
Gautam Jayram, MD
Email:
Principal Investigator
Facility:
Name:
Vanderbilt University Medical Center
Address:
City:
Nashville
Zip:
37232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Darlene Hancock
Investigator:
Last name:
Amy Luckenbaugh, MD
Email:
Principal Investigator
Facility:
Name:
Amarillo Urology Research, LLC
Address:
City:
Amarillo
Zip:
79106
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Jennifer Gillespie
Investigator:
Last name:
David Wilhelm, MD
Email:
Principal Investigator
Facility:
Name:
Urology Associates of North Texas
Address:
City:
Arlington
Zip:
76017
Country:
United States
Status:
Recruiting
Contact:
Last name:
Grace Yoon
Investigator:
Last name:
Michael Collini, MD
Email:
Principal Investigator
Facility:
Name:
Urology Austin, PLLC
Address:
City:
Austin
Zip:
78745
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cecilia Moreno
Investigator:
Last name:
Brian Mazzarella, MD
Email:
Principal Investigator
Facility:
Name:
Houston Methodist Research Institute
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Sejal Dave
Email:
sdave@houstonmethodist.org
Investigator:
Last name:
Raj Satkunasivam, MD
Email:
Principal Investigator
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Marisa Lozano
Investigator:
Last name:
Kelly Bree, MD
Email:
Principal Investigator
Facility:
Name:
Michael E. DeBakey VA Medical Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Thuy Pham
Investigator:
Last name:
Jennifer Taylor, MD
Email:
Principal Investigator
Facility:
Name:
Houston Metro Urology
Address:
City:
Houston
Zip:
77074
Country:
United States
Status:
Recruiting
Contact:
Last name:
Johanna Villamizar
Investigator:
Last name:
Zvi Schiffman, MD
Email:
Principal Investigator
Facility:
Name:
Urology San Antonio PA
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Gavon T Payne
Contact backup:
Last name:
Juliana M Velazquez
Investigator:
Last name:
Daniel Zainfeld, MD
Email:
Principal Investigator
Facility:
Name:
Urology of Virginia (UVA) - Virginia Beach (Devine-Tidewater Urology)
Address:
City:
Virginia Beach
Zip:
23462
Country:
United States
Status:
Recruiting
Contact:
Last name:
James Knight
Investigator:
Last name:
Michael Williams, MD
Email:
Principal Investigator
Facility:
Name:
University of Washington Medical Center
Address:
City:
Seattle
Zip:
98195
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
CHORD Research
Investigator:
Last name:
John Gore, MD
Email:
Principal Investigator
Facility:
Name:
Spokane Urology- Southside
Address:
City:
Spokane
Zip:
99202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amy Bardwell
Investigator:
Last name:
Shane Pearce, MD
Email:
Principal Investigator
Facility:
Name:
Charleston Area Medical Center
Address:
City:
Charleston
Zip:
25304
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jordan Campanelli
Investigator:
Last name:
Michael Stencel, DO
Email:
Principal Investigator
Facility:
Name:
Vancouver Prostate Centre
Address:
City:
Vancouver
Zip:
V5Z 1M9
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Jonathan Ma
Investigator:
Last name:
Peter Black, MD
Email:
Principal Investigator
Facility:
Name:
McGill University Health Center - Montreal General Hospital
Address:
City:
Montréal
Zip:
H4A 3J1
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Rodrigo Skowronski
Investigator:
Last name:
Wassim Kassouf, MD
Email:
Principal Investigator
Start date:
December 14, 2023
Completion date:
January 2030
Lead sponsor:
Agency:
CG Oncology, Inc.
Agency class:
Industry
Source:
CG Oncology, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06111235
https://www.nccn.org/guidelines/recently-published-guidelines
