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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Engineered Oncolytic Adenovirus
Immune checkpoint inhibitor, Monoclonal antibody
Transduction-enhancing agent.
University of California - San Diego
La Jolla, California, United States
University of California - Irvine
Orange, California, United States
Complete response rate in patients
Percentage of patients with a complete response as defined by FDA guidance document dated February 2018 for NMIBC.
Time frame: 12 months
Incidence of adverse events when CG0070 administered intravesically when combined with pembrolizumab.
Percentage of patients with adverse events by grade as determined by NCI CTCAE v5.0
Time frame: 12 months
Median duration of response (DoR)
Median duration of response in patients with a CR or PR
Time frame: 12 months
Median overall survival (OS)
Median overall survival in months in patients
Time frame: 12 months
Median progression free survival
Median duration of progression free survival of patients
Time frame: 12 months
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Ohio State University
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