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

Phase 3

Recruiting

• Conditions: Urologic Cancer; Non Muscle Invasive Bladder Cancer; Urothelial Carcinoma; Bladder Cancer
• Interventions: Drug: Cretostimogene Grenadenorepvec; Other: n-dodecyl-B-D-maltoside

• Registration Number: NCT06111235
• Lead Sponsor: CG Oncology, Inc.

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 with IR-NMIBC.

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 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.

Study Timeline

• Study First Submitted: 2023-10-25
• Study First Submitted QC: 2023-10-30
• Study First Posted: 2023-11-01
• Study Start: 2023-12-14
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-28
• Last Update Posted: 2025-07-30
• Primary Completion: 2028-01
• Study Completion: 2030-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 364

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 90 days 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., Adstiladrin)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cretostimogene after TURBT	Cretostimogene Grenadenorepvec	Following screening confirmation of IR-NMIBC and complete resection of the tumor, participants will be treated with adjuvant cretostimogene.
Cretostimogene after TURBT	n-dodecyl-B-D-maltoside	Following screening confirmation of IR-NMIBC and complete resection of the tumor, participants will be treated with adjuvant cretostimogene.

Primary Outcome Measures

Name	Time	Method
Recurrence Free Survival (RFS)	51 months	Recurrence free survival (RFS) of cretostimogene after TURBT versus surveillance after TURBT

Secondary Outcome Measures

Name	Time	Method
Recurrence Free Survival (RFS) at 12 months and 24 months	51 months (RFS at 12 months) and 63 months (RFS at 24 months)	Recurrence free survival (RFS) of cretostimogene after TURBT versus surveillance after TURBT at 12 months and 24 months
Incidence of Adverse Events	52 months	Safety of cretostimogene following TURBT

Trial Locations

Locations (94)

The University of Kansas Cancer Center; 🇺🇸 Westwood, Kansas, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Urology Centers of Alabama PC; 🇺🇸 Homewood, Alabama, United States

Banner MD Anderson Cancer Center; 🇺🇸 Gilbert, Arizona, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Arizona Institute of Urology PLLC; 🇺🇸 Tucson, Arizona, United States

Arkansas Urology PA; 🇺🇸 Little Rock, Arkansas, United States

Michael G. Oefelein MD Clinical Trials; 🇺🇸 Bakersfield, California, United States

USC/Keck Department of Urology; 🇺🇸 Los Angeles, California, United States

Tower Urology; 🇺🇸 Los Angeles, California, United States

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