Bladder Cancer Clinical Trial
Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin
Summary
To evaluate the activity of intravesical administration of CG0070 and intravenous administration of Pembrolizumab in patients with tissue pathology-confirmed non-muscular invasive bladder cancer (NMIBC) who have Bacillus-Calmette-Guerin (BCG) unresponsive disease with carcinoma in situ (CIS) with or without Ta/T1 papillary disease.
Full 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.
Eligibility Criteria
Key Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
Pathologically confirmed NMIBC with CIS (with or without Ta/T1 disease)
Unresponsive to prior BCG therapy (Lerner 2015) defined as persistent or recurrent CIS alone or with recurrent Ta/T1 (noninvasive papillary disease/tumor invades the sub- epithelial connective tissue) disease within 12 months of completion of adequate BCG therapy. An assessment within 15 months can also qualify when no assessment was performed within 12 months after completion of adequate BCG therapy.
Adequate BCG is defined as at least 5 treatments with induction BCG followed by at least 2 BCG treatments as reinduction or maintenance
Ineligible for radical cystectomy or refusal of radical cystectomy
Adequate organ function
Key Exclusion Criteria:
Immuno-deficient due to chronic steroid or other immunosuppressant use, HIV, or prior organ transplant
Prior treatment with adenovirus-based cancer therapy
Prior therapy with or intolerant to prior checkpoint inhibitor therapy
Clinically significant or active cardiac disease
Active autoimmune disease
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 17 Locations for this study
La Jolla California, 92093, United States
Orange California, 92868, United States
Tampa Florida, 33612, United States
Tampa Florida, 33612, United States
Baltimore Maryland, 21287, United States
Hanover Maryland, 21076, United States
Rochester Minnesota, 55902, United States
New York New York, 10003, United States
Syracuse New York, 13210, United States
Columbus Ohio, 43210, United States
Lancaster Pennsylvania, 17604, United States
Philadelphia Pennsylvania, 19111, United States
Spokane Washington, 99202, United States
Hwasun , 58128, Korea, Republic of
Seoul , 02841, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 06591, Korea, Republic of
Sinchon-dong , , Korea, Republic of
Yangsan , 50612, Korea, Republic of
How clear is this clinincal trial information?
