- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04387461
Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin (CORE-001)
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Hwasun, Korea, Republic of, 58128
- Chonnam National University Hwasun Hospital
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Seoul, Korea, Republic of, 03080
- Seoul National University Hospital
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Seoul, Korea, Republic of, 02841
- Korea University Anam Hospital
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Seoul, Korea, Republic of, 06591
- The Catholic University of Korea Seoul St. Mary'S Hospital
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Sinchon-dong, Korea, Republic of
- Severance Hospital
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Yangsan, Korea, Republic of, 50612
- Pusan National University Yangsan Hospital
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California
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La Jolla, California, United States, 92093
- University of California - San Diego
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Orange, California, United States, 92868
- University of California - Irvine
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Florida
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Tampa, Florida, United States, 33612
- Moffitt Cancer Center
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Tampa, Florida, United States, 33612
- Northwestern University
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Medical Institution
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Hanover, Maryland, United States, 21076
- Chesapeake Urology
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Minnesota
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Rochester, Minnesota, United States, 55902-9823
- Mayo Clinic - Rochester
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New York
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New York, New York, United States, 10003
- New York University
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Syracuse, New York, United States, 13210
- SUNY Upstate Medical University
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Ohio
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Columbus, Ohio, United States, 43210
- Ohio State University
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Pennsylvania
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Lancaster, Pennsylvania, United States, 17604
- Keystone Urology Specialists
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Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
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Washington
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Spokane, Washington, United States, 99202
- Spokane Urology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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 12, the patient will receive another cycle of 6 weekly treatments. If there is no disease present at Week 12 (e.g., complete response) then the patient will receive 3 weekly treatments. Beginning at Week 24, patients will receive weekly x 3 treatments every 3 months through Week 48 then every 24 weeks thereafter. Pembrolizumab will be given intravenous (IV) concurrently starting on Day 1 and continue every 3 weeks for up to 2 years. |
Engineered Oncolytic Adenovirus
Transduction-enhancing agent.
Other Names:
Immune checkpoint inhibitor, Monoclonal antibody
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete response rate in patients
Time Frame: 12 months
|
Percentage of patients with a complete response as defined by FDA guidance document dated February 2018 for NMIBC.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events when CG0070 administered intravesically when combined with pembrolizumab.
Time Frame: 12 months
|
Percentage of patients with adverse events by grade as determined by NCI CTCAE v5.0
|
12 months
|
Median duration of response (DoR)
Time Frame: 12 months
|
Median duration of response in patients with a CR or PR
|
12 months
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Median overall survival (OS)
Time Frame: 12 months
|
Median overall survival in months in patients
|
12 months
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Median progression free survival
Time Frame: 12 months
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Median duration of progression free survival of patients
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: James Burke, CG Oncology, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CG2003C
- Mk3475 Keynote 935 (Other Identifier: Merck)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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