Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC

What this study 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.

Who can join (things the study team will check)

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.

🚫 You may not be able to join if…

• 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

Where this trial is running

• Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
• Mayo Clinic Arizona, Phoenix, Arizona, United States
• Arizona Urology Specialty, Tucson, Arizona, United States
• University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
• Arkansas Urology, Little Rock, Arkansas, United States
• Michael G Oefelein, MD Clinical Trials, Bakersfield, California, United States
• City of Hope, Irvine, California, United States
• Genesis Research (Greater Los Angeles), Los Alamitos, California, United States
• Advanced Urology, Los Angeles, California, United States
• Urology Center of Southern California, Murrieta, California, United States
• University of California, Irvine, Orange, California, United States
• UC Davis, Sacramento, California, United States

+ 68 more sites.

Who to contact

Rebecca Tregunna, MD · 949 409-3700 · Rebecca.Tregunna@cgoncology.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06567743.