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Status:

ACTIVE_NOT_RECRUITING

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

Lead Sponsor:

CG Oncology, Inc.

Conditions:

Non Muscle Invasive Bladder Cancer

Urologic Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief 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 surveillance for the treatment of participants...

Detailed Description

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 quarterl...

Eligibility Criteria

Inclusion

  • 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 ≤ 3 cm) tumor
  • Solitary LG Ta \>3 cm tumor
  • Multifocal LG Ta tumors
  • Primary and solitary HG Ta ≤3 cm tumor
  • LG T1 tumor
  • All visible disease removed by TURBT within 90 days of study randomization
  • Acceptable baseline organ function

Exclusion

  • 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., Adstiladrin)

Key Trial Info

Start Date :

December 14 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2030

Estimated Enrollment :

367 Patients enrolled

Trial Details

Trial ID

NCT06111235

Start Date

December 14 2023

End Date

January 1 2030

Last Update

September 9 2025

Active Locations (95)

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Page 1 of 24 (95 locations)

1

Urology Centers of Alabama PC

Homewood, Alabama, United States, 35209

2

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States, 85234

3

Mayo Clinic

Scottsdale, Arizona, United States, 85259

4

Arizona Institute of Urology PLLC

Tucson, Arizona, United States, 85745