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NCT04452591 · ClinicalTrials.gov registry record · Phase 3
Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin
A Phase 3 study of Non-muscle Invasive Bladder Cancer and High-grade Ta/ T1 Papillary Disease Bladder Cancer, sponsored by CG Oncology.
- Active
- Registry status
- Phase 3
- Development phase
- 190
- Enrollment target
- 20
- Study locations
NCT04452591: Active Phase 3 study of Non-muscle Invasive Bladder Cancer and High-grade Ta/ T1 Papillary Disease Bladder Cancer, sponsored by CG Oncology.
NCT04452591 is a Phase 3 study of Non-muscle Invasive Bladder Cancer and High-grade Ta/ T1 Papillary Disease Bladder Cancer that is active but no longer recruiting, run by CG Oncology. The registered enrollment target is 190 participants, below the 220-participant average among 30 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (14% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04452591, a Phase 3 study of Non-muscle Invasive Bladder Cancer and High-grade Ta/ T1 Papillary Disease Bladder Cancer, is active but no longer recruiting, sponsored by CG Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 190 participants
- Enrollment target
- 20
- Study locations
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
Primary Outcome
To determine the Complete Response rate at any time in patients with BCG-unresponsive CIS with or without concomitant HG Ta/T1 papillary disease.
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 |
What the registry record for NCT04452591 still lists
NCT04452591 is an interventional study that assigns participants to a tested intervention. The registered 190 participants enrollment target is mid-sized for trials with a published cap, below the 220-participant average among 30 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (14% lower).
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.
NCT04452591 names 20 study sites across 11 states, led by California, Arizona, Colorado.
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.
What interventions are being tested in trial NCT04452591?
The interventions under investigation include: Cretostimogene Grenadenorepvec (BIOLOGICAL), n-dodecyl-B-D-maltoside (OTHER).
Who is sponsoring clinical trial NCT04452591?
This trial is sponsored by CG Oncology, which has 6 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT04452591's enrollment target sits among peer trials
190 11th of 30 higher than 20 of 30 other Non-muscle Invasive Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-muscle Invasive Bladder Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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