Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin
NCT ID: NCT04387461
Last Updated: 2024-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
35 participants
INTERVENTIONAL
2020-12-08
2024-05-28
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm
CG0070 will be administered intravesically (IVE) following a sequence of bladder washes with 5% DDM and normal saline. CG0070 will be administered weekly x 6 on Day 1 to Week 6. If the patient shows persistent high-grade disease at Week 13, the patient will receive another cycle of 6 weekly treatments. If there is no disease present at Week 13 (e.g., complete response) then the patient will receive 3 weekly treatments.
Beginning at Week 25, patients will receive weekly x 3 treatments every 3 months through Week 49 then every 24 weeks thereafter.
Pembrolizumab will be given intravenous (IV) concurrently starting on Day 1 and continue every 6 weeks for up to 2 years.
CG0070
Engineered Oncolytic Adenovirus
Pembrolizumab Injection
Immune checkpoint inhibitor, Monoclonal antibody
n-dodecyl-B-D-maltoside
Transduction-enhancing agent.
Interventions
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CG0070
Engineered Oncolytic Adenovirus
Pembrolizumab Injection
Immune checkpoint inhibitor, Monoclonal antibody
n-dodecyl-B-D-maltoside
Transduction-enhancing agent.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
CG Oncology, Inc.
INDUSTRY
Responsible Party
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Locations
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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, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, , South Korea
Severance Hospital
Sinchŏn-dong, , South Korea
Pusan National University Yangsan Hospital
Yangsan, , South Korea
Countries
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References
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Li R, Shah PH, Stewart TF, Nam JK, Bivalacqua TJ, Lamm DL, Uchio EM, Geynisman DM, Jacob JM, Meeks JJ, Dickstein R, Pearce SM, Kang SH, Jung SI, Kamat AM, Burke JM, Keegan KA, Steinberg GD. Oncolytic adenoviral therapy plus pembrolizumab in BCG-unresponsive non-muscle-invasive bladder cancer: the phase 2 CORE-001 trial. Nat Med. 2024 Aug;30(8):2216-2223. doi: 10.1038/s41591-024-03025-3. Epub 2024 Jun 6.
Other Identifiers
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KEYNOTE-935
Identifier Type: OTHER
Identifier Source: secondary_id
MK-3475-935
Identifier Type: OTHER
Identifier Source: secondary_id
CG2003C
Identifier Type: -
Identifier Source: org_study_id
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