Clinical trial NCT06111235: A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT
Official title: A Phase 3, Randomized Study of Adjuvant Cretostimogene Grenadenorepvec Versus Observation for the Treatment of Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR-NMIBC) Following Transurethral Resection of Bladder Tumor (TURBT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Non Muscle Invasive Bladder Cancer
Urologic Cancer
Bladder Cancer
Urothelial Carcinoma
Keywords: Urology
Bladder Cancer
Non Muscle Invasive Bladder Cancer
Intermediate Risk Non Muscle Invasive Bladder Cancer
Cretostimogene Grenadenorepvec
Lead sponsor: CG Oncology, Inc.
Sponsor class: INDUSTRY
First posted: 2023-11-01
Enrollment: 364
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT followed by adjuvant cretostimogene versus TURBT alone for the treatment of participants with IR-NMIBC
Primary purpose: TREATMENT

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.

Eligibility 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 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)

Primary outcomes:
measure: Recurrence Free Survival (RFS)
timeFrame: 51 months
Secondary outcomes:
measure: Recurrence Free Survival (RFS) at 12 months and 24 months
timeFrame: 51 months (RFS at 12 months) and 63 months (RFS at 24 months)
measure: Incidence of Adverse Events
timeFrame: 52 months
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Urology Centers of Alabama PC
state: Alabama
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Tucson
country: United States
facility: Arizona Institute of Urology PLLC
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Urology PA
state: Arkansas
city: Bakersfield
country: United States
facility: Michael G. Oefelein MD Clinical Trials
state: California
city: Los Angeles
country: United States
facility: USC/Keck Department of Urology
state: California
city: Los Angeles
country: United States
facility: Tower Urology
state: California
city: Orange
country: United States
facility: Sun Kim Urology
state: California
city: Orange
country: United States
facility: University of California Irvine Medical Center (UCIMC)
state: California
city: Sacramento
country: United States
facility: University of California Davis Cancer Center
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Aurora
country: United States
facility: Colorado Clinical Research
state: Colorado
city: Lone Tree
country: United States
facility: Urology Associates, PC
state: Colorado
city: Hartford
country: United States
facility: Hartford HealthCare Medical Group
state: Connecticut
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Daytona Beach
country: United States
facility: Advanced Urology Institute
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Cancer Center
state: Florida
city: Lakeland
country: United States
facility: Lakeland Regional Health
state: Florida
city: Largo
country: United States
facility: Advanced Urology Institute, LLC
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Atlanta
country: United States
facility: Emory Winship Cancer Center
state: Georgia
city: Savannah
country: United States
facility: Velocity Clinical Research- Savanah Urological Associates
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Glenview
country: United States
facility: UroPartners LLC
state: Illinois
city: Lisle
country: United States
facility: Duly Health and Care
state: Illinois
city: Carmel
country: United States
facility: Urology of Indiana, LLC
state: Indiana
city: Greenwood
country: United States
facility: Urology of Indiana
state: Indiana
city: West Des Moines
country: United States
facility: Urology Center of Iowa Research
state: Iowa
city: Wichita
country: United States
facility: Wichita Urology Group
state: Kansas
city: Louisville
country: United States
facility: First Urology, PSC
state: Kentucky
city: Lafayette
country: United States
facility: Southern Urology
state: Louisiana
city: Shreveport
country: United States
facility: Regional Urology, LLC
state: Louisiana
city: Baltimore
country: United States
facility: Chesapeake Urology Associates, LLC
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital Green Spring Station
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Cancer Center at Beth Israel Deaconess Medical Center - Research
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Roseville
country: United States
facility: Comprehensive Urology
state: Michigan
city: Troy
country: United States
facility: Michigan Institute of Urology, PC
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Southaven
country: United States
facility: The Urology Group
state: Mississippi
city: Saint Louis
country: United States
facility: SSM Health Saint Louis University Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Objective Health - Specialty Clinical Research of St. Louis
state: Missouri
city: Reno
country: United States
facility: Urology Nevada
state: Nevada
city: Morristown
country: United States
facility: Garden State Urology, LLC- Morristown Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey - Cancer Center
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Integrated Medical Professionals PLLC
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: Syracuse
country: United States
facility: Associated Medical Professionals of NY
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Durham
country: United States
facility: Duke Cancer Center
state: North Carolina
city: Cincinnati
country: United States
facility: Urology Group
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
city: Toledo
country: United States
facility: University of Toledo
state: Ohio
city: Springfield
country: United States
facility: Oregon Urology Insititute
state: Oregon
city: Bala-Cynwyd
country: United States
facility: Midlantic Urology
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Health Milton S. Hershey Medical Center
state: Pennsylvania
city: Lancaster
country: United States
facility: Keystone Urology Specialists
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania - Perelman School of Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: North Charleston
country: United States
facility: Lowcountry Urology Clinics
state: South Carolina
city: Germantown
country: United States
facility: The Conrad Pearson Clinic
state: Tennessee
city: Nashville
country: United States
facility: Urology Associates, P.C.
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Urology Research, LLC
state: Texas
city: Arlington
country: United States
facility: Urology Associates of North Texas
state: Texas
city: Austin
country: United States
facility: Urology Austin, PLLC
state: Texas
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Metro Urology
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio PA
state: Texas
city: San Antonio
country: United States
facility: UT Health San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah- Huntsman Cancer Institute
state: Utah
city: Virginia Beach
country: United States
facility: Urology of Virginia (UVA) - Virginia Beach (Devine-Tidewater Urology)
state: Virginia
city: Seattle
country: United States
facility: Benaroya Research Institute at Virginia Mason
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Spokane
country: United States
facility: Spokane Urology- Southside
state: Washington
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
city: Madison
country: United States
facility: University of Wisconsin Medical Foundation
state: Wisconsin
city: Vancouver
country: Canada
facility: Vancouver Prostate Centre
state: British Columbia
city: Halifax
country: Canada
facility: Nova Scotia Health Centre of Applied Urology Research
state: Nova Scotia
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network (UHN) - Princess Margaret Cancer Centre
state: Ontario
city: Montréal
country: Canada
facility: McGill University Health Center - Montreal General Hospital
state: Quebec
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: Robert Svatek, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang SS, Boorjian SA, Chou R, Clark PE, Daneshmand S, Konety BR, Pruthi R, Quale DZ, Ritch CR, Seigne JD, Skinner EC, Smith ND, McKiernan JM. Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline. J Urol. 2016 Oct;196(4):1021-9. doi: 10.1016/j.juro.2016.06.049. Epub 2016 Jun 16.