Title
A Phase 3, Randomized Study of CG0070 versus Observation for the Treatment of Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR-NMIBC) Following Transurethral Resection of Bladder Tumor (TURBT)

Description
A Phase 3, Randomized Study of Adjuvant Cretostimogene Grenadenorepvec Versus Observation for the Treatment of Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR-NMIBC) Following Transurethral Resection of Bladder Tumor (TURBT)

Objective
Primary Objective: To evaluate the relapse free survival (RFS) of transurethral resection of bladder tumor (TURBT) followed by CG0070 versus TURBT in patients with intermediate-risk non-muscle invasive bladder cancer (IR-NMIBC)

Treatment Participants will be randomized 1:1 to cretostimogene grenadenorepvec after TURBT (Arm A) vs surveillance after TURBT (Arm B).

Participants in Arm A will receive an induction course and then quarterly maintenance courses of cretostimogene through Month 13, if there is no disease recurrence.

Disease status will be assessed using urine cytology, cystoscopy, and directed TURBT/biopsy (if indicated) every 3 months for the first 2 years after randomization and then every 6 months for an additional year or until disease recurrence. CT Urogram/MRU every 12 months.

Participants in Arm B who recur with IR-NMIBC after TURBT and surveillance will be offered treatment with cretostimogene as per the treatment schedule in Arm A.

Key Eligibility Inclusion Criteria:

Pathologically confirmed IR-NMIBC, per American Urologic Association/Society of Urologic Oncology/National Comprehensive Cancer Network guidelines, within 90 days of participant randomization:



Recurrent LG Ta within 12 months of prior LG or HG (HG Ta
Solitary LG Ta >3 cm tumor

Multifocal LG Ta tumors

Primary and solitary HG Ta
LG T1 tumor



All visible disease removed by TURBT within 90 days of study randomization

Acceptable baseline organ function

High-risk NMIBC (e.g., HG T1, Recurrent or multifocal HG Ta>3cm tumor(s), CIS)

Low-Risk NMIBC (e.g., solitary LG Ta
Disease in the prostatic urethra at any time or in the upper genitourinary tract within 24 months of randomization

Muscle-invasive bladder cancer, locally advanced or metastatic bladder cancer

Prior treatment with any human adenovirus serotype 5 based therapy (e.g., Adstiladrin)

Applicable Disease Sites
Bladder

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital