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)

To evaluate the activity of intravesical administration of CG0070 and intravenous administration of Pembrolizumab in patients with tissue pathology-confirmed non-muscle invasive bladder cancer (NMIBC) who have Bacillus-Calmette-Guerin (BCG) unresponsive disease with carcinoma in situ (CIS) with or without Ta/T1 papillary disease.

Study Overview

• Status: Completed
• Conditions: Non Muscle Invasive Bladder Cancer
• Intervention / Treatment: Biological: CG0070; Other: n-dodecyl-B-D-maltoside; Biological: Pembrolizumab Injection

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
• Enrollment (Actual): 35
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Hwasun, Korea, Republic of, 58128
    • Chonnam National University Hwasun Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 02841
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, 06591
    • The Catholic University of Korea Seoul St. Mary'S Hospital
  • Sinchon-dong, Korea, Republic of
    • Severance Hospital
  • Yangsan, Korea, Republic of, 50612
    • Pusan National University Yangsan Hospital
• United States
  • California
    • La Jolla, California, United States, 92093
      • University of California - San Diego
    • Orange, California, United States, 92868
      • University of California - Irvine
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
    • Tampa, Florida, United States, 33612
      • Northwestern University
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Medical Institution
    • Hanover, Maryland, United States, 21076
      • Chesapeake Urology
  • Minnesota
    • Rochester, Minnesota, United States, 55902-9823
      • Mayo Clinic - Rochester
  • New York
    • New York, New York, United States, 10003
      • New York University
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17604
      • Keystone Urology Specialists
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
  • Washington
    • Spokane, Washington, United States, 99202
      • Spokane Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
• 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)

Number of Arms

1

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 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.

Biological: CG0070; Engineered Oncolytic Adenovirus; Other: n-dodecyl-B-D-maltoside; Transduction-enhancing agent.; Other Names: DDM; Biological: Pembrolizumab Injection; Immune checkpoint inhibitor, Monoclonal antibody; Other Names: KEYTRUDA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Median duration of response (DoR)	Median duration of response in patients with a CR or PR	12 months
Median overall survival (OS)	Median overall survival in months in patients	12 months
Median progression free survival	Median duration of progression free survival of patients	12 months

Collaborators and Investigators

• Sponsor: CG Oncology, Inc.
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: James Burke, CG Oncology, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2020
• Primary Completion (Actual): March 7, 2023
• Study Completion (Actual): May 28, 2024

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: May 12, 2020
• First Posted (Actual): May 13, 2020

Study Record Updates

• Last Update Posted (Actual): September 25, 2024
• Last Update Submitted That Met QC Criteria: September 23, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: high-grade Ta papillary disease; high-grade T1 papillary disease; carcinoma in situ; Bacillus-Calmette-Guerin Unresponsive
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Pembrolizumab
• Other Study ID Numbers: CG2003C; KEYNOTE-935 (Other Identifier: Merck Sharp & Dohme LLC); MK-3475-935 (Other Identifier: Merck Sharp & Dohme LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No