A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT

ID#: NCT06111235

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: December 14, 2023

End Date: January 01, 2030

Contact Information:
Shelly Basye, MD
949-409-3700
Andy Darilek, MD
949-409-3700
Summary: This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT followed by cretostimogene grenadenorepvec versus TURBT followed by observation for the treatment of participants with IR-NMIBC.
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)
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