Actively Recruiting
Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC
Led by CG Oncology, Inc. · Updated on 2026-04-08
325
Participants Needed
65
Research Sites
171 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with pathologically confirmed high-risk high-grade non-muscle-invasive bladder cancer (NMIBC) within 90 days of treatment allocation
- Cohort A: BCG-na�ve NMIBC (CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS)
- Cohort B: BCG-exposed NMIBC (CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS)
- Cohort CX: BCG-unresponsive or BCG-exposed NMIBC (CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS)
- All visible bladder cancer must be resected and CIS resected or treated within 90 days prior to treatment allocation
- Acceptable baseline organ function
You will not qualify if you...
- History or current diagnosis of muscle-invasive, locally advanced, or metastatic bladder cancer
- High-grade urothelial carcinoma in the upper urinary tract or prostatic urethra within 24 months
- T2 upper tract disease within 48 months
- Any history of locally advanced, nodal, or metastatic disease in the upper urinary tract
- Significant immunodeficiency
- Pregnant or breastfeeding
- Cohort CX only: prior serial intravesical gemcitabine within 24 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 65 locations
1
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Arizona Urology Specialty
Tucson, Arizona, United States, 85704
Withdrawn
3
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Actively Recruiting
4
Arkansas Urology
Little Rock, Arkansas, United States, 72211
Actively Recruiting
5
Michael G Oefelein, MD Clinical Trials
Bakersfield, California, United States, 93301
Actively Recruiting
6
Genesis Research (Greater Los Angeles)
Los Alamitos, California, United States, 90720
Actively Recruiting
7
Advanced Urology
Los Angeles, California, United States, 90045
Withdrawn
8
Urology Center of Southern California
Murrieta, California, United States, 92563
Actively Recruiting
9
University of California, Irvine
Orange, California, United States, 92868
Actively Recruiting
10
Om research
San Diego, California, United States, 91223
Actively Recruiting
11
University of Southern California
San Diego, California, United States, 92123
Actively Recruiting
12
Genesis Research (Greater Los Angeles)
Torrance, California, United States, 90503
Actively Recruiting
13
Colorado Urology
Lakewood, Colorado, United States, 80228
Actively Recruiting
14
Urology Associates, Lone Tree
Lone Tree, Colorado, United States, 80124
Actively Recruiting
15
University of Florida
Gainesville, Florida, United States, 32611
Actively Recruiting
16
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
17
Advanced Urology Institute (Solaris)
Largo, Florida, United States, 33771
Actively Recruiting
18
Advanced Urology Institute
Oxford, Florida, United States, 34484
Actively Recruiting
19
Advanced Urology Institute - Tallahassee (Solaris)
Tallahassee, Florida, United States, 32308
Withdrawn
20
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
21
Associated Urological Specialists
Chicago Ridge, Illinois, United States, 60415
Actively Recruiting
22
Uropartners
Glenview, Illinois, United States, 60026
Actively Recruiting
23
Urology of Indiana - Carmel
Carmel, Indiana, United States, 46032
Actively Recruiting
24
Urology of Indiana, LLC (US Urology Partners)
Greenwood, Indiana, United States, 46143
Actively Recruiting
25
First Urology, PSC
Jeffersonville, Indiana, United States, 47130
Actively Recruiting
26
Urologic Specialists of Northwest Indiana (Solaris)
Merrillville, Indiana, United States, 46410
Actively Recruiting
27
Urology Center of Iowa Research
Clive, Iowa, United States, 50325
Actively Recruiting
28
Wichita Urology Group
Wichita, Kansas, United States, 67226
Actively Recruiting
29
Southern Urology (Urology America)
Lafayette, Louisiana, United States, 70508
Actively Recruiting
30
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121
Actively Recruiting
31
Anne Arundel Urology
Annapolis, Maryland, United States, 21401
Actively Recruiting
32
Chesapeake Urology Research Associates
Hanover, Maryland, United States, 21076
Actively Recruiting
33
Comprehensive Urology
Royal Oak, Michigan, United States, 48073
Actively Recruiting
34
Michigan Institute of Urology (Solaris)
Troy, Michigan, United States, 48084
Actively Recruiting
35
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
36
Minnesota Urology
Woodbury, Minnesota, United States, 55123
Actively Recruiting
37
Specialty Clinical Research of St. Louis
St Louis, Missouri, United States, 63141
Actively Recruiting
38
Adult and Adolescent Urology
Omaha, Nebraska, United States, 68114
Actively Recruiting
39
Integrated Medical Professionals, PLLC (Solaris)
New York, New York, United States, 10016
Actively Recruiting
40
University of Rochester
Rochester, New York, United States, 14620
Actively Recruiting
41
SUNY Upstate
Syracuse, New York, United States, 13202
Actively Recruiting
42
Associated Medical Professionals of NY, PLLC (US Urology Partners)
Syracuse, New York, United States, 13210
Actively Recruiting
43
Montefiore Medical Center
The Bronx, New York, United States, 10461
Actively Recruiting
44
The Urology Group (Solaris)
Cincinnati, Ohio, United States, 45212
Actively Recruiting
45
University of Cincinnati Cancer Center
Cincinnati, Ohio, United States, 45267
Actively Recruiting
46
Central Ohio Urology Group (US Urology Partners)
Gahanna, Ohio, United States, 43230
Actively Recruiting
47
Oregon Urology Institute
Springfield, Oregon, United States, 97447
Actively Recruiting
48
Midlantic Urology (Solaris)
Bala-Cynwyd, Pennsylvania, United States, 19004
Actively Recruiting
49
Penn State University Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
50
Keystone Urology Specialists
Lancaster, Pennsylvania, United States, 17604
Actively Recruiting
51
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
52
Charleston Area Medical Center
Charleston, South Carolina, United States, 25304
Actively Recruiting
53
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, United States, 229572
Actively Recruiting
54
Lowcountry Urology (Solaris)
North Charleston, South Carolina, United States, 29406
Actively Recruiting
55
The Conrad Pearson Clinic (Urology America)
Germantown, Tennessee, United States, 38138
Actively Recruiting
56
Urology Associates, PC
Nashville, Tennessee, United States, 37209
Actively Recruiting
57
Amarillo Urology Research
Amarillo, Texas, United States, 79106
Completed
58
UPNT Research Institute, LLC
Arlington, Texas, United States, 76017
Actively Recruiting
59
Urology Austin, PLLC (Urology America)
Austin, Texas, United States, 78745
Actively Recruiting
60
Urology Clinics of North Texas, PLLC
Dallas, Texas, United States, 75231
Actively Recruiting
61
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
62
Houston Methodist
Houston, Texas, United States, 77030
Actively Recruiting
63
Urology San Antonio, PA dba USA Clinical Trials
San Antonio, Texas, United States, 78229
Actively Recruiting
64
Urology of Virginia
Virginia Beach, Virginia, United States, 23462
Actively Recruiting
65
Spokane Urology
Spokane, Washington, United States, 99202
Actively Recruiting
Research Team
R
Rebecca Tregunna, MD
CONTACT
P
Pat Keegan, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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