An Expanded Access Program of Cretostimogene Grenadenorepvec for Treatment of NMIBC for Patients Unresponsive to BCG
1 other identifier
expanded_access
N/A
1 country
26
Brief Summary
This is an open-label, expanded access trial designed to provide access to cretostimogene in patients with NMIBC (specifically CIS with or without HG Ta/T1) unresponsive to BCG.
Trial Health
Trial Health Score
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26 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2024
CompletedFirst Posted
Study publicly available on registry
June 5, 2024
CompletedApril 14, 2026
April 1, 2026
May 30, 2024
April 13, 2026
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Have pathologically confirmed BCG unresponsive CIS. There is no maximum limit to the amount of prior BCG treatment, but maintenance BCG should be administered on a schedule consistent with standard induction-maintenance protocols. Specifically, the definition of BCG unresponsive CIS will also require the following:
- Pathologically confirmed relapsed or persistent CIS (with or without HG Ta or HG T1 disease)
- Completion of qualifying BCG treatment (e.g., "5+2" minimum exposure) within 15 months of the initial qualifying dose of BCG.
- Have all Ta and/or T1 disease and all CIS resected or fulgurated, as feasible, prior to study treatment
- Ineligible to receive radical cystectomy (medically unfit) or refusal of radical cystectomy according to Investigator assessment.
- Acceptable baseline organ function
You may not qualify if:
- Muscle invasive bladder cancer, locally advanced or metastatic bladder cancer.
- Has had active autoimmune or inflammatory disease requiring systemic treatment within 4 weeks of Day 1. Replacement therapy is not considered an excluded form of systemic treatment and is allowed.
- Has received systemic anticancer therapy, including investigational agents, within 4 weeks of Day 1
- Is pregnant, currently breastfeeding or intending to breastfeed, beginning at Screening through 1 week after the last study treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Michael G. Oefelein Clinical Trials
Bakersfield, California, 93301, United States
University of Southern California / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
McR, Llc.
Murrieta, California, 92563, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Advanced Urology Institute
Daytona Beach, Florida, 32114, United States
Lakeland Regional Medical Center - Hollis Cancer Center
Lakeland, Florida, 33805, United States
Advanced Urology Institute
Largo, Florida, 33771, United States
Emory University
Atlanta, Georgia, 30322, United States
Uropartners c/o Associated Urological Specialists
Chicago Ridge, Illinois, 60415, United States
UroPartners, LLC
Glenview, Illinois, 60026, United States
Urologic Specialists of Northwest Indiana
Merrillville, Indiana, 46410, United States
Urology Center of Iowa Research
Clive, Iowa, 50325, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Michigan Institute of Urology, PC
Troy, Michigan, 40484, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
The Urology Group, P.C.
Southaven, Mississippi, 38671, United States
Integrated Medical Professionals, PLLC
New York, New York, 10016, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004, United States
Lowcountry Urology Clinics, PA
North Charleston, South Carolina, 29406, United States
Urology Partners of North Texas Research Institute
Arlington, Texas, 76017, United States
Urology Clinics of North Texas
Dallas, Texas, 75231, United States
Urology San Antonio, PA dba USA Clinical Trials
San Antonio, Texas, 78229, United States
Digestive Health Research of North Texas
Wichita Falls, Texas, 76301, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Spokane Urology
Spokane, Washington, 99202, United States
Related Publications (2)
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.
PMID: 27317986BACKGROUNDHolzbeierlein JM, Bixler BR, Buckley DI, Chang SS, Holmes R, James AC, Kirkby E, McKiernan JM, Schuckman AK. Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline: 2024 Amendment. J Urol. 2024 Apr;211(4):533-538. doi: 10.1097/JU.0000000000003846. Epub 2024 Jan 24.
PMID: 38265030BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2024
First Posted
June 5, 2024
Last Updated
April 14, 2026
Record last verified: 2026-04