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 observation for the treatment of participants with IR-NMIBC.

Detailed Description

Participants will be randomized 1:1 to cretostimogene grenadenorepvec after TURBT (Arm A) vs observation 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, complete bladder visualization (e.g., 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.

Participants in Arm B who recur with IR-NMIBC after TURBT and observation will be offered treatment with cretostimogene as per the treatment schedule in Arm A.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

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: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02
• Primary Completion: 2028-01
• Study Completion: 2030-01

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 12 weeks of study randomization

• Acceptable baseline organ function

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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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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 observation 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 observation after TURBT at 12 months and 24 months
Incidence of Adverse Events	52 months	Safety of cretostimogene following TURBT

Trial Locations

Locations (72)

Urology of Indiana; 🇺🇸 Greenwood, Indiana, United States

UT Health San Antonio; 🇺🇸 San Antonio, Texas, 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

Sun Kim Urology; 🇺🇸 Orange, California, United States

University of California Irvine Medical Center (UCIMC); 🇺🇸 Orange, California, United States

University of California Davis Cancer Center; 🇺🇸 Sacramento, California, United States

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States

Colorado Clinical Research; 🇺🇸 Aurora, Colorado, United States

Urology Associates, PC; 🇺🇸 Lone Tree, Colorado, United States

MedStar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Advanced Urology Institute; 🇺🇸 Daytona Beach, Florida, United States

Lakeland Regional Health; 🇺🇸 Lakeland, Florida, United States

Advanced Urology Institute, LLC; 🇺🇸 Largo, Florida, United States

Emory Winship Cancer Center; 🇺🇸 Atlanta, Georgia, United States

Velocity Clinical Research- Savanah Urological Associates; 🇺🇸 Savannah, Georgia, United States

UroPartners LLC; 🇺🇸 Glenview, Illinois, United States

Duly Health and Care; 🇺🇸 Lisle, Illinois, United States

Urology of Indiana, LLC; 🇺🇸 Carmel, Indiana, United States

Urology Center of Iowa Research; 🇺🇸 West Des Moines, Iowa, United States

Wichita Urology Group; 🇺🇸 Wichita, Kansas, United States

Regional Urology, LLC; 🇺🇸 Shreveport, Louisiana, United States

First Urology, PSC; 🇺🇸 Louisville, Kentucky, United States

Southern Urology; 🇺🇸 Lafayette, Louisiana, United States

Chesapeake Urology Associates, LLC; 🇺🇸 Baltimore, Maryland, United States

Johns Hopkins Hospital Green Spring Station; 🇺🇸 Baltimore, Maryland, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Cancer Center at Beth Israel Deaconess Medical Center - Research; 🇺🇸 Boston, Massachusetts, United States

Michigan Institute of Urology, PC; 🇺🇸 Troy, Michigan, United States

The Urology Group; 🇺🇸 Southaven, Mississippi, United States

Objective Health - Specialty Clinical Research of St. Louis; 🇺🇸 Saint Louis, Missouri, United States

Urology Nevada; 🇺🇸 Reno, Nevada, United States

Garden State Urology, LLC- Morristown Medical Center; 🇺🇸 Morristown, New Jersey, United States

Rutgers Cancer Institute of New Jersey - Cancer Center; 🇺🇸 New Brunswick, New Jersey, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States

Integrated Medical Professionals PLLC; 🇺🇸 New York, New York, United States

NYU Langone Health; 🇺🇸 New York, New York, United States

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

Associated Medical Professionals of NY; 🇺🇸 Syracuse, New York, United States

Duke Cancer Center; 🇺🇸 Durham, North Carolina, United States

Urology Group; 🇺🇸 Cincinnati, Ohio, United States

Oregon Urology Insititute; 🇺🇸 Springfield, Oregon, United States

Midlantic Urology; 🇺🇸 Bala-Cynwyd, Pennsylvania, United States

Penn State Health Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States

Keystone Urology Specialists; 🇺🇸 Lancaster, Pennsylvania, United States

University of Pennsylvania - Perelman School of Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States

The Miriam Hospital; 🇺🇸 Providence, Rhode Island, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Carolina Urologic Research Center; 🇺🇸 Myrtle Beach, South Carolina, United States

Lowcountry Urology Clinics; 🇺🇸 North Charleston, South Carolina, United States

The Conrad Pearson Clinic; 🇺🇸 Germantown, Tennessee, United States

Urology Associates, P.C.; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Amarillo Urology Research, LLC; 🇺🇸 Amarillo, Texas, United States

Urology Associates of North Texas; 🇺🇸 Arlington, Texas, United States

Urology Austin, PLLC; 🇺🇸 Austin, Texas, United States

Houston Methodist Research Institute; 🇺🇸 Houston, Texas, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Michael E. DeBakey VA Medical Center; 🇺🇸 Houston, Texas, United States

Houston Metro Urology; 🇺🇸 Houston, Texas, United States

Urology San Antonio PA; 🇺🇸 San Antonio, Texas, United States

Urology of Virginia (UVA) - Virginia Beach (Devine-Tidewater Urology); 🇺🇸 Virginia Beach, Virginia, United States

University of Washington Medical Center; 🇺🇸 Seattle, Washington, United States

Spokane Urology- Southside; 🇺🇸 Spokane, Washington, United States

Charleston Area Medical Center; 🇺🇸 Charleston, West Virginia, United States

Vancouver Prostate Centre; 🇨🇦 Vancouver, British Columbia, Canada

McGill University Health Center - Montreal General Hospital; 🇨🇦 Montréal, Quebec, Canada