Tests cretostimogene grenadenorepvec in high-risk non-muscle-invasive bladder cancer
Tests cretostimogene grenadenorepvec in adults with high-risk bladder cancer confined to the bladder lining.
Plain-language title generated from the registry record
Registry title: Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC
Key facts
- Where
- Alexandria, Amarillo, Annapolis, Arlington, Atlanta, Austin, Bakersfield, Bala-Cynwyd, Boston, Carmel, Chapel Hill, Charleston, Charlotte, Chicago Ridge, Cincinnati, Cleveland, Clive, Columbus, Dallas, Gahanna, Gainesville, Germantown, Gilbert, Glenview, Greenwood, Hackensack, Hanover, Hershey, Houston, Irvine, Jacksonville, Jeffersonville, Lafayette, Lakewood, Lancaster, Largo, Lisle, Little Rock, Lone Tree, Los Alamitos, Los Angeles, Merrillville, Murrieta, Myrtle Beach, Nashville, New Orleans, New York, North Charleston, Omaha, Orange, Oxford, Philadelphia, Phoenix, Portland, Raleigh, Rochester, Royal Oak, Sacramento, San Antonio, San Diego, Spokane, Springfield, St Louis, Syracuse, Tallahassee, The Bronx, Torrance, Troy, Tucson, Virginia Beach, Wichita, and Woodbury, United StatesSee the 79 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with high-risk, high-grade non-muscle-invasive bladder cancer. It tests the drug cretostimogene grenadenorepvec in separate groups.
- Age
- 18 years or older
- Sex
- Women and men can join
- Disease stage
- High-risk, high-grade non-muscle-invasive bladder cancer confirmed by pathology within 90 days before treatment. This means CIS with or without Ta/T1 disease, or high-grade Ta/T1 papillary-only disease without CIS. All visible disease must be removed, and all CIS removed or burned off, as far as possible.
- Earlier treatment
- Cohort A: people who have not had BCG before. Cohort B: people who have been exposed to BCG. Cohort CX: people whose cancer is BCG-unresponsive or who have been exposed to BCG. Cohort CX cannot have had serial intravesical gemcitabine within 24 months.
Main reasons for not taking part
- Current or past muscle-invasive, locally advanced or metastatic bladder cancer
- High-grade cancer of the upper urinary tract or prostatic urethra within 24 months, or T2 in the upper tract within 48 months
- Any past locally advanced, nodal or metastatic disease in the upper urinary tract
- Significant immunodeficiency
- Pregnant or breastfeeding
Read by machine on 9 November 2026.
Where in United States
- Potomac UrologyAlexandria, United StatesTaking people
- Amarillo Urology ResearchAmarillo, United StatesNo longer taking part
- Anne Arundel UrologyAnnapolis, United StatesTaking people
- UPNT Research Institute, LLCArlington, United StatesTaking people
- Emory UniversityAtlanta, United StatesTaking people
- Urology Austin, PLLC (Urology America)Austin, United StatesTaking people
- Michael G Oefelein, MD Clinical TrialsBakersfield, United StatesTaking people
- Midlantic Urology (Solaris)Bala-Cynwyd, United StatesTaking people
- Brigham and Women's HospitalBoston, United StatesTaking people
- Urology of Indiana - CarmelCarmel, United StatesTaking people
- University of North CarolinaChapel Hill, United StatesTaking people
- Charleston Area Medical CenterCharleston, United StatesTaking people
- Atrium Health/Levine CenterCharlotte, United StatesTaking people
- Associated Urological SpecialistsChicago Ridge, United StatesTaking people
- The Urology Group (Solaris)Cincinnati, United StatesTaking people
- University of Cincinnati Cancer CenterCincinnati, United StatesTaking people
- Cleveland ClinicCleveland, United StatesTaking people
- Urology Center of Iowa ResearchClive, United StatesTaking people
- Ohio State UniversityColumbus, United StatesTaking people
- Urology Clinics of North Texas, PLLCDallas, United StatesTaking people
- UT Southwestern Medical CenterDallas, United StatesTaking people
- Central Ohio Urology Group (US Urology Partners)Gahanna, United StatesTaking people
- University of FloridaGainesville, United StatesTaking people
- The Conrad Pearson Clinic (Urology America)Germantown, United StatesTaking people
- Banner MD Anderson Cancer CenterGilbert, United StatesTaking people
- UroPartnersGlenview, United StatesTaking people
- Urology of Indiana, LLC (US Urology Partners)Greenwood, United StatesTaking people
- Hackensack University Medical CenterHackensack, United StatesTaking people
- Chesapeake Urology Research AssociatesHanover, United StatesTaking people
- Penn State University Milton S. Hershey Medical CenterHershey, United StatesTaking people
- Houston MethodistHouston, United StatesTaking people
- City of HopeIrvine, United StatesTaking people
- Mayo Clinic FloridaJacksonville, United StatesTaking people
- First Urology, PSCJeffersonville, United StatesTaking people
- Southern Urology (Urology America)Lafayette, United StatesTaking people
- Colorado UrologyLakewood, United StatesTaking people
- Keystone Urology SpecialistsLancaster, United StatesTaking people
- Advanced Urology Institute (Solaris)Largo, United StatesTaking people
- AccellacareLisle, United StatesTaking people
- Arkansas UrologyLittle Rock, United StatesTaking people
- University of Arkansas for Medical SciencesLittle Rock, United StatesTaking people
- Urology Associates, Lone TreeLone Tree, United StatesTaking people
- Genesis Research (Greater Los Angeles)Los Alamitos, United StatesTaking people
- Advanced UrologyLos Angeles, United StatesNo longer taking part
- Urologic Specialists of Northwest Indiana (Solaris)Merrillville, United StatesTaking people
- Urology Center of Southern CaliforniaMurrieta, United StatesTaking people
- Carolina Urologic Research Center, LLCMyrtle Beach, United StatesTaking people
- Urology Associates PCNashville, United StatesTaking people
- Ochsner Medical CenterNew Orleans, United StatesTaking people
- Integrated Medical Professionals, PLLC (Solaris)New York, United StatesTaking people
- Lowcountry Urology (Solaris)North Charleston, United StatesTaking people
- Adult and Adolescent UrologyOmaha, United StatesTaking people
- University of California IrvineOrange, United StatesTaking people
- Advanced Urology InstituteOxford, United StatesTaking people
- University of PennsylvaniaPhiladelphia, United StatesTaking people
- Mayo Clinic - ArizonaPhoenix, United StatesTaking people
- Oregon Health Science UniversityPortland, United StatesTaking people
- Portland VAPortland, United StatesTaking people
- Associated Urologist of North Carolina (Solaris)Raleigh, United StatesTaking people
- Mayo Clinic - RochesterRochester, United StatesTaking people
- University of RochesterRochester, United StatesTaking people
- Comprehensive UrologyRoyal Oak, United StatesTaking people
- UC DavisSacramento, United StatesTaking people
- Urology San Antonio, PA dba USA Clinical TrialsSan Antonio, United StatesTaking people
- Om ResearchSan Diego, United StatesTaking people
- University of Southern CaliforniaSan Diego, United StatesTaking people
- Spokane UrologySpokane, United StatesTaking people
- Oregon Urology InstituteSpringfield, United StatesTaking people
- Specialty Clinical Research of St. LouisSt Louis, United StatesTaking people
- Associated Medical Professionals of NY, PLLC (US Urology Partners)Syracuse, United StatesTaking people
- SUNY UpstateSyracuse, United StatesTaking people
- Advanced Urology Institute - Tallahassee (Solaris)Tallahassee, United StatesNo longer taking part
- Montefiore Medical CenterThe Bronx, United StatesTaking people
- Genesis Research (Greater Los Angeles)Torrance, United StatesTaking people
- Michigan Institute of Urology (Solaris)Troy, United StatesTaking people
- Arizona Urology SpecialtyTucson, United StatesNo longer taking part
- Urology of VirginiaVirginia Beach, United StatesTaking people
- Wichita Urology GroupWichita, United StatesTaking people
- Minnesota UrologyWoodbury, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- CG Oncology, Inc.
- Trial code
- NCT06567743
- Record updated
- 3 September 2026
- Original description
This is a Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants with High-Risk Non-Muscle-Invasive Bladder Cancer.Read full original descriptionShow less
A Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants With High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)
This is a Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants with High-Risk Non-Muscle-Invasive Bladder Cancer.
Exclusion: Current or past history of muscle-invasive, locally advanced or metastatic bladder cancer; High-grade urothelial carcinoma in the upper urinary tract or prostatic urethra within 24 months or T2 in upper tract within 48 months or any history of locally advanced/ nodal or metastatic disease in the upper urinary tract; Significant immunodeficiency; Pregnant or breastfeeding; Cohort CX Only: serial intravesical gemcitabine within 24 months.
Cohort A Key Inclusion Criteria:; Pathologically confirmed BCG-naïve high-risk high-grade NMIBC (i.e., CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS) within 90 days of treatment allocation; All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation; Acceptable baseline organ function; Cohort B Key Inclusion Criteria:; Pathologically confirmed BCG-exposed high-risk high-grade NMIBC (i.e., CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS) within 90 days of treatment allocation; All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation; Acceptable baseline organ function; Cohort CX Inclusion Criteria; Pathologically confirmed high-risk high-grade BCG-unresponsive or BCG-exposed NMIBC (i.e., CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS) within 90 days of treatment allocation; All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation; Acceptable baseline organ function.