Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin (CORE-001)

• ClinicalTrials.gov Identifier: NCT04387461
• Recruitment Status: Active, not recruiting
• First Posted: May 13, 2020
• Last Update Posted: August 24, 2022
• Sponsor: CG Oncology, Inc.
• Collaborator: Merck Sharp & Dohme LLC
• Information provided by (Responsible Party): CG Oncology, Inc.

Tracking Information

• First Submitted Date: May 5, 2020
• First Posted Date: May 13, 2020
• Last Update Posted Date: August 24, 2022
• Actual Study Start Date: December 8, 2020
• Estimated Primary Completion Date: June 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 12, 2020)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 12, 2020)

• 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
• Median duration of response (DoR) [ Time Frame: 12 months ]
  Median duration of response in patients with a CR or PR
• Median overall survival (OS) [ Time Frame: 12 months ]
  Median overall survival in months in patients
• Median progression free survival [ Time Frame: 12 months ]
  Median duration of progression free survival of patients

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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)
• 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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Non Muscle Invasive Bladder Cancer

Intervention

• Biological: CG0070
  Engineered Oncolytic Adenovirus
• Biological: Pembrolizumab Injection
  Immune checkpoint inhibitor, Monoclonal antibody
  Other Name: Keytruda
• Other: n-dodecyl-B-D-maltoside
  Transduction-enhancing agent.
  Other Name: DDM

Study Arms

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.

Interventions:

• Biological: CG0070
• Biological: Pembrolizumab Injection
• Other: n-dodecyl-B-D-maltoside

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: August 22, 2022): 35
• Original Estimated Enrollment (submitted: May 12, 2020): 37
• Estimated Study Completion Date: June 2023
• Estimated Primary Completion Date: June 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of, United States

Administrative Information

• NCT Number: NCT04387461
• Other Study ID Numbers: CG2003C; Mk3475 Keynote 935 ( Other Identifier: Merck )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: CG Oncology, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: CG Oncology, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Merck Sharp & Dohme LLC

Investigators

• Principal Investigator: James Burke; CG Oncology, Inc.

• PRS Account: CG Oncology, Inc.
• Verification Date: June 2022