Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin
Running, not enrolling · Phase 3
Conditions studied: Non Muscle Invasive Bladder Cancer, High-grade Ta/ T1 Papillary Disease Bladder Cancer
In brief
This is a Phase 3, open-label, single arm trial designed to evaluate Cretostimogene patients with NMIBC who have failed prior BCG therapy. Up to approximately 115 CIS bladder cancer patients with or without HG Ta or HG T1 papillary disease will be enrolled under the original protocol through Amendment 4, which will comprise Cohort C. Cohort C is closed to enrollment. Under Amendment 5-1, Cohort P was added to enroll up to 70 patients with HG Ta/T1 papillary bladder cancer. Under Amendment 6, the target number of patients enrolled in Cohort P was increased to 75. Cohort P is open to enrollment Cohort C and Cohort P will be analyzed and reported separately. Patients will have had to fail prior BCG therapy which is defined as having persistent or recurrent disease within 12 months (Cohort C) or 6 months (Cohort P) following the completion of adequate BCG therapy for HGUC
Key facts
- Study ID
- NCT04452591
- Run by
- CG Oncology, Inc.
- People needed
- 190
- Starts
- 2020-10-27
- Expected to finish
- 2031-12-24
- Last updated by the study team
- 2026-07-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- BCG Oncology — Phoenix, Arizona, United States
- Mayo Clinic Cancer Center — Phoenix, Arizona, United States
- Arizona Institute of Urology — Tucson, Arizona, United States
- Arkansas Urology — Little Rock, Arkansas, United States
- University of California - Irvine — Irvine, California, United States
- American Insititute of Research — Los Angeles, California, United States
- Genesis Research — Sherman Oaks, California, United States
- Genesis Research LLC — Torrance, California, United States
- University of Colorado — Aurora, Colorado, United States
- Colorado Clinical Research — Lakewood, Colorado, United States
- Urology Associates, Research Department — Lone Tree, Colorado, United States
- MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
- Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
- Moffit Cancer Center — Tampa, Florida, United States
- Emory University — Atlanta, Georgia, United States
- Urology Indiana LLC — Greenwood, Indiana, United States
- The University of Kansas Cancer Center — Westwood, Kansas, United States
- Wichita Urology — Wichita, Kansas, United States
- Southern Urology — Lafayette, Louisiana, United States
- Chesapeake Urology — Hanover, Maryland, United States
- Chesapeake Urology — Severna Park, Maryland, United States
- Brigham and Women's Hospital — Boston, Massachusetts, United States
- Mayo Rochester — Rochester, Minnesota, United States
- Mercy Medical Center — St Louis, Missouri, United States
- Urology Centers Alabama — Homewood, Alabama, United States
Full record on ClinicalTrials.gov
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