Brief Title: Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

• Non Muscle Invasive Bladder Cancer
• Urologic Cancer
• Bladder Cancer
• Urothelial Carcinoma

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:
1. Recurrent LG Ta within 12 months of prior LG or HG (HG Ta ≤ 3 cm) tumor

- 2. Solitary LG Ta >3 cm tumor

- 3. Multifocal LG Ta tumors

- 4. Primary and solitary HG Ta ≤3 cm tumor

- 5. LG T1 tumor

- * All visible disease removed by TURBT within 12 weeks of study randomization

- * Acceptable baseline organ function
Exclusion Criteria:
* High-risk NMIBC (e.g., HG T1, Recurrent or multifocal HG Ta>3cm tumor(s), CIS)

- * Low-Risk NMIBC (e.g., solitary LG Ta ≤3 cm tumor)

- * 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., Ad-interferon or Adstiladrin)

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Robert Svatek, MD

Role: Principal Investigator

Affiliation: University of Texas Health Science Center, San Antonio

Overall Contact

Name: Shelly Basye, MD, Andy Darilek, MD

Phone: 949-419-6149, 949-419-6149

Email: pivot-006@CGoncology.com; Recruitment@cgoncology.com, pivot-006@CGoncology.com; Recruitment@cgoncology.com

LOCATION