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
- Halifax, CanadaSee the site
- Phase
- Phase 2
Where in Canada
- Centre of Applied Urology Research/Nova Scotia Health AuthorityHalifax, CanadaTaking 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.