Bladder Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

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:

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 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 is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

364

Study ID:

NCT06111235

Recruitment Status:

Recruiting

Sponsor:

CG Oncology, Inc.

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There are 32 Locations for this study

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Arizona Institute of Urology PLLC
Tucson Arizona, 85745, United States More Info
Andrea Navarrette
Contact
Kalpesh Patel, MD
Principal Investigator
Arkansas Urology PA
Little Rock Arkansas, 72211, United States More Info
Katie O'Brien
Contact
R. Jonathan Henderson, MD
Principal Investigator
Michael G. Oefelein MD Clinical Trials
Bakersfield California, 93301, United States More Info
Evelyn De La Cruz
Contact
Michael Oefelein, MD
Principal Investigator
USC/Keck Department of Urology
Los Angeles California, 90033, United States More Info
Qingru Feng
Contact
Anne Schuckman, MD
Principal Investigator
Tower Urology
Los Angeles California, 90048, United States More Info
Shiblee Nomanee
Contact
David Josephson, MD
Principal Investigator
Sun Kim Urology
Orange California, 92868, United States More Info
Tam Le
Contact
Sun Kim, MD
Principal Investigator
Urology Associates, PC
Lone Tree Colorado, 80124, United States More Info
Bradley Gord
Contact
Bradley Bell, MD
Principal Investigator
Lakeland Regional Health
Lakeland Florida, 33805, United States More Info
Maczko Bridget
Contact
Peter Hinds, MD
Principal Investigator
Advanced Urology Institute, LLC
Largo Florida, 33771, United States More Info
Amy Franklin
Contact
Matthew Truesdale, MD
Principal Investigator
Velocity Clinical Research- Savanah Urological Associates
Savannah Georgia, 31405, United States More Info
Jamie Hill
Contact
Buffi Boyd, MD
Principal Investigator
Wichita Urology Group
Wichita Kansas, 67226, United States More Info
Tyler Gentry
Contact
PHilippe Nabbout, MD
Principal Investigator
First Urology, PSC
Louisville Kentucky, 47130, United States More Info
Samantha Taylor
Contact
Ryan Malone, MD
Principal Investigator
Southern Urology
Lafayette Louisiana, 70508, United States More Info
Wilson Simmons
Contact
Jason Bourque, MD
Principal Investigator
Chesapeake Urology Associates, LLC
Baltimore Maryland, 21204, United States More Info
Katie Wright
Contact
Rian Dickstein, MD
Principal Investigator
Johns Hopkins Hospital Green Spring Station
Baltimore Maryland, 21287, United States More Info
Tina Wlajnitz
Contact
Max Kates, MD
Principal Investigator
Objective Health - Specialty Clinical Research of St. Louis
Saint Louis Missouri, 63141, United States More Info
Nicholas Bossaller
Contact
Gregory Auffenberg, MD
Principal Investigator
Montefiore Medical Center
Bronx New York, 10461, United States More Info
Andrea Asencio
Contact
Alexander Sankin, MD
Principal Investigator
Integrated Medical Professionals PLLC
New York New York, 10016, United States More Info
Michael Yang
Contact
Jed Kaminetsky, MD
Principal Investigator
Oregon Urology Insititute
Springfield Oregon, 97477, United States More Info
Maxim DiMarco
Contact
Bryan Mehlhaff, MD
Principal Investigator
Keystone Urology Specialists
Lancaster Pennsylvania, 17604, United States More Info
Kristina Baker
Contact
Paul Sieber, MD
Principal Investigator
University of Pennsylvania - Perelman School of Medicine
Philadelphia Pennsylvania, 19104, United States More Info
Dylan Kolman
Contact
Trinity Bivalacqua, MD
Principal Investigator
The Miriam Hospital
Providence Rhode Island, 02905, United States More Info
Taylor Braunagel
Contact
Dragan Golijanin, MD
Principal Investigator
Carolina Urologic Research Center
Myrtle Beach South Carolina, 29572, United States More Info
Jessica Richardson
Contact
Neal Shore, MD
Principal Investigator
Lowcountry Urology Clinics
North Charleston South Carolina, 29406, United States More Info
Samara Grimes
Contact
Justin Ellett, MD
Principal Investigator
The Conrad Pearson Clinic
Germantown Tennessee, 38138, United States More Info
Russell Grigsby
Contact
Ravi Chauhan, MD
Principal Investigator
Urology Associates, P.C.
Nashville Tennessee, 37209, United States More Info
Joe Wallace
Contact
Gautam Jayram, MD
Principal Investigator
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States More Info
Darlene Hancock
Contact
Amy Luckenbaugh, MD
Principal Investigator
Urology Associates of North Texas
Arlington Texas, 76017, United States More Info
Michael Collini, MD
Principal Investigator
Urology Austin, PLLC
Austin Texas, 78745, United States More Info
Cecilia Moreno
Contact
Brian Mazzarella, MD
Principal Investigator
Houston Metro Urology
Houston Texas, 77074, United States More Info
Johanna Villamizar
Contact
Zvi Schiffman, MD
Principal Investigator
Urology San Antonio PA
San Antonio Texas, 78229, United States More Info
Gavon T Payne
Contact
Juliana M Velazquez
Contact
Daniel Zainfeld, MD
Principal Investigator
Spokane Urology- Southside
Spokane Washington, 99202, United States More Info
Amy Bardwell
Contact
Shane Pearce, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

364

Study ID:

NCT06111235

Recruitment Status:

Recruiting

Sponsor:


CG Oncology, Inc.

How clear is this clinincal trial information?

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