NCT04452591

Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin

A Phase 3 Study of Cretostimogene Grenadenorepvec in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus-Calmette-Guerin (BCG)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 190 (estimated)
• Sponsor: CG Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Cohort C(All Countries) : An open-label trial designed to evaluate Cretostimogene + DDM in patients with NMIBC who have failed prior BCG therapy. Single treatment arm that enrolled 115 patients with carcinoma in situ with or without concomitant high-grade Ta or T1 papillary disease BCG failure is defined as a persistent or recurrent disease within 12 months of completion of adequate BCG therapy. Cohort P(Japan and the United States Only): To determine the all-cause High Grade Event Free Survival (HG-EFS) of cretostimogene in up to 75 patients with BCG-unresponsive HG Ta/T1 papillary disease without CIS. BCG failure is defined as a persistent or recurrent disease within 6 months of completion of adequate BCG therapy.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	Cretostimogene Grenadenorepvec	Engineered Oncolytic Adenovirus
OTHER	n-dodecyl-B-D-maltoside	Transduction-enhancing agent.

Timeline

• Start date: 2020-10-27
• Primary completion: 2030-06-16
• Completion: 2031-12-24
• First posted: 2020-06-30
• Last updated: 2026-03-16

Locations

86 sites across 6 countries: United States, Australia, Canada, Japan, South Korea, Taiwan

Regulatory

• FDA-regulated drug study