Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin
NCT04387461 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2024-09-25
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.
Conditions
- Non Muscle Invasive Bladder Cancer
Interventions
- BIOLOGICAL
-
CG0070
Engineered Oncolytic Adenovirus
- BIOLOGICAL
-
Pembrolizumab Injection
Immune checkpoint inhibitor, Monoclonal antibody
- OTHER
-
n-dodecyl-B-D-maltoside
Transduction-enhancing agent.
Sponsors & Collaborators
- collaborator INDUSTRY
-
CG Oncology, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-08
- Primary Completion
- 2023-03-07
- Completion
- 2024-05-28
- FDA Drug
- Yes
Countries
- United States
- South Korea
Study Locations
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