Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin

Non Muscle Invasive Bladder Cancer Clinical Trial

— 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04387461
• Other study ID #: CG2003C
• Secondary ID: Mk3475 Keynote 9
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 8, 2020
• Est. completion date: June 2023

Study information

• Verified date: June 2022
• Source: CG Oncology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Non Muscle Invasive Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Biological:
• CG0070
Engineered Oncolytic Adenovirus
• Pembrolizumab Injection
Immune checkpoint inhibitor, Monoclonal antibody

Other:
• n-dodecyl-B-D-maltoside
Transduction-enhancing agent.

Locations

Country	Name	City	State
Korea, Republic of	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
United States	Johns Hopkins Medical Institution	Baltimore	Maryland
United States	Ohio State University	Columbus	Ohio
United States	Chesapeake Urology	Hanover	Maryland
United States	University of California - San Diego	La Jolla	California
United States	Keystone Urology Specialists	Lancaster	Pennsylvania
United States	New York University	New York	New York
United States	University of California - Irvine	Orange	California
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Mayo Clinic - Rochester	Rochester	Minnesota
United States	Spokane Urology	Spokane	Washington
United States	SUNY Upstate Medical University	Syracuse	New York
United States	Moffitt Cancer Center	Tampa	Florida
United States	Northwestern University	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
CG Oncology, Inc.	Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response rate in patients	Percentage of patients with a complete response as defined by FDA guidance document dated February 2018 for NMIBC.	12 months
Secondary	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	12 months
Secondary	Median duration of response (DoR)	Median duration of response in patients with a CR or PR	12 months
Secondary	Median overall survival (OS)	Median overall survival in months in patients	12 months
Secondary	Median progression free survival	Median duration of progression free survival of patients	12 months