Back to resultsStudy of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin (CORE-001)
Primary Purpose
Non Muscle Invasive Bladder Cancer
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CG0070
Pembrolizumab Injection
n-dodecyl-B-D-maltoside
Sponsored by
About this trial
This is an interventional treatment trial for Non Muscle Invasive Bladder Cancer focused on measuring high-grade Ta papillary disease, high-grade T1 papillary disease, carcinoma in situ, Bacillus-Calmette-Guerin Unresponsive
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
Sites / Locations
- University of California - San Diego
- University of California - Irvine
- Moffitt Cancer Center
- Northwestern University
- Johns Hopkins Medical Institution
- Chesapeake Urology
- Mayo Clinic - Rochester
- New York University
- SUNY Upstate Medical University
- Ohio State University
- Keystone Urology Specialists
- Fox Chase Cancer Center
- Spokane Urology
- Chonnam National University Hwasun Hospital
- Korea University Anam Hospital
- Seoul National University Hospital
- The Catholic University of Korea Seoul St. Mary's Hospital
- Severance Hospital
- Pusan National University Yangsan Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
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.
Outcomes
Primary Outcome Measures
Complete response rate in patients
Percentage of patients with a complete response as defined by FDA guidance document dated February 2018 for NMIBC.
Secondary Outcome Measures
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
Median duration of response (DoR)
Median duration of response in patients with a CR or PR
Median overall survival (OS)
Median overall survival in months in patients
Median progression free survival
Median duration of progression free survival of patients
Full Information
NCT ID
NCT04387461
First Posted
May 5, 2020
Last Updated
August 22, 2022
Sponsor
CG Oncology, Inc.
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT04387461
Brief Title
Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin
Acronym
CORE-001
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 Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 8, 2020 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CG Oncology, Inc.
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Muscle Invasive Bladder Cancer
Keywords
high-grade Ta papillary disease, high-grade T1 papillary disease, carcinoma in situ, Bacillus-Calmette-Guerin Unresponsive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
CG0070
Intervention Description
Engineered Oncolytic Adenovirus
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab Injection
Other Intervention Name(s)
Keytruda
Intervention Description
Immune checkpoint inhibitor, Monoclonal antibody
Intervention Type
Other
Intervention Name(s)
n-dodecyl-B-D-maltoside
Other Intervention Name(s)
DDM
Intervention Description
Transduction-enhancing agent.
Primary Outcome Measure Information:
Title
Complete response rate in patients
Description
Percentage of patients with a complete response as defined by FDA guidance document dated February 2018 for NMIBC.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Incidence of adverse events when CG0070 administered intravesically when combined with pembrolizumab.
Description
Percentage of patients with adverse events by grade as determined by NCI CTCAE v5.0
Time Frame
12 months
Title
Median duration of response (DoR)
Description
Median duration of response in patients with a CR or PR
Time Frame
12 months
Title
Median overall survival (OS)
Description
Median overall survival in months in patients
Time Frame
12 months
Title
Median progression free survival
Description
Median duration of progression free survival of patients
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Burke
Organizational Affiliation
CG Oncology, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California - San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
University of California - Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Northwestern University
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Johns Hopkins Medical Institution
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Chesapeake Urology
City
Hanover
State/Province
Maryland
ZIP/Postal Code
21076
Country
United States
Facility Name
Mayo Clinic - Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902-9823
Country
United States
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Keystone Urology Specialists
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Spokane Urology
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Sinchon-dong
Country
Korea, Republic of
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
ZIP/Postal Code
50612
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin
We'll reach out to this number within 24 hrs