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

• Status: Recruiting
• Trial end date: 2030-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CG Oncology, Inc.

Criteria

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)