Brief Title: Cretostimogene Grenadenorepvec in High-Risk NMIBC

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

• High-Risk Non-Muscle-Invasive Bladder Cancer

ELIGIBILITY

Cohort A Key Inclusion Criteria:
* Pathologically confirmed BCG-naïve, CIS-containing (i.e., CIS with or without concomitant HG Ta/T1) high-risk NMIBC within 90 days of randomization.

- * Participants with BCG-naïve NMIBC should have either:
* No prior treatment with BCG OR

- * No treatment with BCG within the past 24 months prior to current pathological diagnosis OR

- * A maximum of 1 or 2 doses of BCG within the past 24 months prior to current pathological diagnosis.

- * All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to randomization.

- * Acceptable baseline organ function.
Key Exclusion Criteria:
* Current or past history of muscle-invasive, locally advanced or metastatic bladder cancer.

- * High-grade disease in the upper urinary tract or prostatic urethra within 24 months of randomization or any history of muscle-invasive, locally advanced or metastatic disease in the upper urinary tract.

- * Significant immunodeficiency.

- * Pregnant or breastfeeding.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Pat Keegan

Role: Study Director

Affiliation: CG Oncology

Overall Contact

Name: Rebecca Tregunna, MD, Andy Darilek

Phone: +1.949.419.6105, +1.406.628.5708

Email: Rebecca.Tregunna@cgoncology.com, andy.darilek@CGoncology.com

LOCATION