NCT04387461

Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin

A Phase 2, Single Arm Study of CG0070 Combined With Pembrolizumab in Patients With Non Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: CG Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the activity of intravesical administration of CG0070 and intravenous administration of Pembrolizumab in patients with tissue pathology-confirmed non-muscle invasive bladder cancer (NMIBC) who have Bacillus-Calmette-Guerin (BCG) unresponsive disease with carcinoma in situ (CIS) with or without Ta/T1 papillary disease.

Detailed description

An opened label trial designed to evaluate CG0070 and DDM in combination with Pembrolizumab in patients with NMIBC who have failed prior BCG therapy. The target population of 37 subjects with CIS with or without concomitant high-grade Ta or T1 papillary disease will be enrolled. BCG failure is defined as persistent or recurrent disease within 12 months of completion of adequate BCG therapy.

Conditions

• Non Muscle Invasive Bladder Cancer

Interventions

Type	Name	Description
BIOLOGICAL	CG0070	Engineered Oncolytic Adenovirus
BIOLOGICAL	Pembrolizumab Injection	Immune checkpoint inhibitor, Monoclonal antibody
OTHER	n-dodecyl-B-D-maltoside	Transduction-enhancing agent.

Timeline

• Start date: 2020-12-08
• Primary completion: 2023-03-07
• Completion: 2024-05-28
• First posted: 2020-05-13
• Last updated: 2024-09-25

Locations

19 sites across 2 countries: United States, South Korea

Regulatory

• FDA-regulated drug study