Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin
NCT04452591 · View on ClinicalTrials.gov ↗
Study Summary
This is a Phase 3, open-label, single arm trial designed to evaluate Cretostimogene patients with NMIBC who have failed prior BCG therapy. Up to approximately 115 CIS bladder cancer patients with or without HG Ta or HG T1 papillary disease will be enrolled under the original protocol through Amendment 4, which will comprise Cohort C. Cohort C is closed to enrollment. Under Amendment 5-1, Cohort P was added to enroll up to 70 patients with HG Ta/T1 papillary bladder cancer. Under Amendment 6, the target number of patients enrolled in Cohort P was increased to 75. Cohort P is open to enrollment Cohort C and Cohort P will be analyzed and reported separately. Patients will have had to fail prior BCG therapy which is defined as having persistent or recurrent disease within 12 months (Cohort C) or 6 months (Cohort P) following the completion of adequate BCG therapy for HGUC
Conditions Studied
Interventions
- BIOLOGICAL Cretostimogene Grenadenorepvec
- OTHER n-dodecyl-B-D-maltoside
Study Locations (20)
California
- University of California - Irvine — Irvine
- American Insititute of Research — Los Angeles
- Genesis Research — Sherman Oaks
- Genesis Research LLC — Torrance
Arizona
- BCG Oncology — Phoenix
- Mayo Clinic Cancer Center — Phoenix
- Arizona Institute of Urology — Tucson
Colorado
- University of Colorado — Aurora
- Colorado Clinical Research — Lakewood
- Urology Associates, Research Department — Lone Tree
Florida
- Mayo Clinic - Jacksonville — Jacksonville
- Moffit Cancer Center — Tampa
Kansas
- The University of Kansas Cancer Center — Westwood
- Wichita Urology — Wichita
Alabama
- Urology Centers Alabama — Homewood
Arkansas
- Arkansas Urology — Little Rock
District of Columbia
- MedStar Washington Hospital Center — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2020-10-27 |
| Est. Completion | 2031-12-24 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04452591
The ClinicalTrials.gov registry entry for NCT04452591 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 190 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CG Oncology, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Non Muscle Invasive Bladder Cancer appearing as the primary indexed condition, and to 2 interventions — of which Cretostimogene Grenadenorepvec is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04452591 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Arizona, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04452591 about?
NCT04452591 is a clinical study titled "Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin". This is a Phase 3, open-label, single arm trial designed to evaluate Cretostimogene patients with NMIBC who have failed prior BCG therapy. Up to approximately 115 CIS bladder cancer patients with or without HG Ta or HG T1 papillary disease will be enrolled under the original protocol through Amendme...
What is the current status of trial NCT04452591?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 190 participants. The study started on 2020-10-27. Estimated completion is 2031-12-24.
What conditions does trial NCT04452591 study?
This clinical trial studies the following conditions: Non Muscle Invasive Bladder Cancer, High-grade Ta/ T1 Papillary Disease Bladder Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04452591?
The interventions under investigation include: Cretostimogene Grenadenorepvec (BIOLOGICAL), n-dodecyl-B-D-maltoside (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04452591?
This trial is sponsored by CG Oncology, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04452591 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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