Spots Global Cancer Trial Database for Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin
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Trial Identification
Brief Title: Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin
Official Title: 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)
Study ID: NCT04387461
Conditions
Study Description
Brief 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.
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California - San Diego, La Jolla, California, United States
University of California - Irvine, Orange, California, United States
Moffitt Cancer Center, Tampa, Florida, United States
Northwestern University, Tampa, Florida, United States
Johns Hopkins Medical Institution, Baltimore, Maryland, United States
Chesapeake Urology, Hanover, Maryland, United States
Mayo Clinic - Rochester, Rochester, Minnesota, United States
New York University, New York, New York, United States
SUNY Upstate Medical University, Syracuse, New York, United States
Ohio State University, Columbus, Ohio, United States
Keystone Urology Specialists, Lancaster, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Spokane Urology, Spokane, Washington, United States
Chonnam National University Hwasun Hospital, Hwasun, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Severance Hospital, Sinchon-dong, , Korea, Republic of
Pusan National University Yangsan Hospital, Yangsan, , Korea, Republic of
Contact Details
Name: James Burke
Affiliation: CG Oncology, Inc.
Role: PRINCIPAL_INVESTIGATOR
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