A Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants With High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)
Status: Recruiting
Location: See all (65) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants with High-Risk Non-Muscle-Invasive Bladder Cancer.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Pathologically confirmed BCG-naïve high-risk high-grade NMIBC (i.e., CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS) within 90 days of treatment allocation.
• All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation.
• Acceptable baseline organ function.
• Pathologically confirmed BCG-exposed high-risk high-grade NMIBC (i.e., CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS) within 90 days of treatment allocation.
• All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation.
• Acceptable baseline organ function.
• Pathologically confirmed high-risk high-grade BCG-unresponsive or BCG-exposed NMIBC (i.e., CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS) within 90 days of treatment allocation.
• All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation.
• Acceptable baseline organ function.
Locations
United States
Arkansas
Arkansas Urology
RECRUITING
Little Rock
University of Arkansas for Medical Sciences
RECRUITING
Little Rock
Arizona
Mayo Clinic Arizona
RECRUITING
Phoenix
Arizona Urology Specialty
WITHDRAWN
Tucson
California
Michael G Oefelein, MD Clinical Trials
RECRUITING
Bakersfield
Genesis Research (Greater Los Angeles)
RECRUITING
Los Alamitos
Advanced Urology
WITHDRAWN
Los Angeles
Urology Center of Southern California
RECRUITING
Murrieta
University of California, Irvine
RECRUITING
Orange
Om research
RECRUITING
San Diego
University of Southern California
RECRUITING
San Diego
Genesis Research (Greater Los Angeles)
RECRUITING
Torrance
Colorado
Colorado Urology
RECRUITING
Lakewood
Urology Associates, Lone Tree
RECRUITING
Lone Tree
Florida
University of Florida
RECRUITING
Gainesville
Mayo Clinic Florida
RECRUITING
Jacksonville
Advanced Urology Institute (Solaris)
RECRUITING
Largo
Advanced Urology Institute
RECRUITING
Oxford
Advanced Urology Institute - Tallahassee (Solaris)
WITHDRAWN
Tallahassee
Georgia
Emory University
RECRUITING
Atlanta
Iowa
Urology Center of Iowa Research
RECRUITING
Clive
Illinois
Associated Urological Specialists
RECRUITING
Chicago Ridge
Uropartners
RECRUITING
Glenview
Indiana
Urology of Indiana - Carmel
RECRUITING
Carmel
Urology of Indiana, LLC (US Urology Partners)
RECRUITING
Greenwood
First Urology, PSC
RECRUITING
Jeffersonville
Urologic Specialists of Northwest Indiana (Solaris)
RECRUITING
Merrillville
Kansas
Wichita Urology Group
RECRUITING
Wichita
Louisiana
Southern Urology (Urology America)
RECRUITING
Lafayette
Ochsner Medical Center
RECRUITING
New Orleans
Maryland
Anne Arundel Urology
RECRUITING
Annapolis
Chesapeake Urology Research Associates
RECRUITING
Hanover
Michigan
Comprehensive Urology
RECRUITING
Royal Oak
Michigan Institute of Urology (Solaris)
RECRUITING
Troy
Minnesota
Mayo Clinic Rochester
RECRUITING
Rochester
Minnesota Urology
RECRUITING
Woodbury
Missouri
Specialty Clinical Research of St. Louis
RECRUITING
St Louis
Nebraska
Adult and Adolescent Urology
RECRUITING
Omaha
New York
Integrated Medical Professionals, PLLC (Solaris)
RECRUITING
New York
University of Rochester
RECRUITING
Rochester
Associated Medical Professionals of NY, PLLC (US Urology Partners)
RECRUITING
Syracuse
SUNY Upstate
RECRUITING
Syracuse
Montefiore Medical Center
RECRUITING
The Bronx
Ohio
The Urology Group (Solaris)
RECRUITING
Cincinnati
University of Cincinnati Cancer Center
RECRUITING
Cincinnati
Central Ohio Urology Group (US Urology Partners)
RECRUITING
Gahanna
Oregon
Oregon Urology Institute
RECRUITING
Springfield
Pennsylvania
Midlantic Urology (Solaris)
RECRUITING
Bala-cynwyd
Penn State University Milton S. Hershey Medical Center
RECRUITING
Hershey
Keystone Urology Specialists
RECRUITING
Lancaster
University of Pennsylvania
RECRUITING
Philadelphia
South Carolina
Charleston Area Medical Center
RECRUITING
Charleston
Carolina Urologic Research Center, LLC
RECRUITING
Myrtle Beach
Lowcountry Urology (Solaris)
RECRUITING
North Charleston
Tennessee
The Conrad Pearson Clinic (Urology America)
RECRUITING
Germantown
Urology Associates, PC
RECRUITING
Nashville
Texas
Amarillo Urology Research
COMPLETED
Amarillo
UPNT Research Institute, LLC
RECRUITING
Arlington
Urology Austin, PLLC (Urology America)
RECRUITING
Austin
Urology Clinics of North Texas, PLLC
RECRUITING
Dallas
UT Southwestern Medical Center
RECRUITING
Dallas
Houston Methodist
RECRUITING
Houston
Urology San Antonio, PA dba USA Clinical Trials
RECRUITING
San Antonio
Virginia
Urology of Virginia
RECRUITING
Virginia Beach
Washington
Spokane Urology
RECRUITING
Spokane
Contact Information
Primary
Rebecca Tregunna, MD
Rebecca.Tregunna@cgoncology.com
949 409-3700
Backup
Pat Keegan, MD
pat.keegan@cgoncology.com
949 409-3700
Time Frame
Start Date: 2024-09-16
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 325
Treatments
Experimental: Experimental: Cohort A, Arm 1
Cretostimogene (1 x 1012 vp) will be administered intravesically via the current instillation method
Experimental: Experimental: Cohort A, Arm 2
Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.
Experimental: Experimental: Cohort A, Arm 3
Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.
Experimental: Experimental: Cohort B, Arm 1
Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.
Experimental: Experimental: Cohort B, Arm 2
Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.
Experimental: Experimental: Cohort CX, Arm 1
At all treatment visits cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method followed by gemcitabine instilled intravesically
Experimental: Experimental: Cohort CX, Arm 2
Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method for two consecutive weeks, followed by gemcitabine administered intravesically in the third week on a cyclic 2:1 visit schedule basis
Related Therapeutic Areas
Sponsors
Leads: CG Oncology, Inc.