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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 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 226-participant average among 28 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (16% lower). The trial reports 20 study locations across 11 states.

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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

Conditions Studied

Non-muscle Invasive Bladder Cancer High-grade Ta/ T1 Papillary Disease Bladder Cancer

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

FieldValue
Enrollment Target 190 participants
Start Date 2020-10-27
Est. Completion 2031-12-24
Phase Phase 3

Sponsor

CG Oncology

6 total trials

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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, categorized as Phase 3. The registered enrollment target is 190 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 226-participant average among 28 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (16% lower). The listed sponsor is CG Oncology, which has 6 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.

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