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

NCT04387461 | Completed Phase 2 DMC FDA Drug

• 3 other identifiers: CG2003CKEYNOTE-935MK-3475-935
• Study Type: interventional
• Target: 35
• Locations: 2 countries
• Sites: 19

Brief Summary

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.

Conditions

Non Muscle Invasive Bladder Cancer

Keywords

high-grade Ta papillary disease; high-grade T1 papillary disease; carcinoma in situ; Bacillus-Calmette-Guerin Unresponsive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Incidence of adverse events when CG0070 administered intravesically when combined with pembrolizumab.

  12 months

• Median duration of response (DoR)

  12 months

• Median overall survival (OS)

  12 months

• Median progression free survival

  12 months

Study Arms (1)

Single Arm

EXPERIMENTAL

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; Biological: Pembrolizumab Injection; Other: n-dodecyl-B-D-maltoside

Interventions

CG0070 BIOLOGICAL

Engineered Oncolytic Adenovirus

Single Arm

Pembrolizumab Injection BIOLOGICAL

Immune checkpoint inhibitor, Monoclonal antibody

Also known as: KEYTRUDA®

Single Arm

n-dodecyl-B-D-maltoside OTHER

Transduction-enhancing agent.

Also known as: DDM

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CG Oncology, Inc.: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (19)

University of California - San Diego

La Jolla, California, 92093, United States

Location

University of California - Irvine

Orange, California, 92868, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Northwestern University

Tampa, Florida, 33612, United States

Location

Johns Hopkins Medical Institution

Baltimore, Maryland, 21287, United States

Location

Chesapeake Urology

Hanover, Maryland, 21076, United States

Location

Mayo Clinic - Rochester

Rochester, Minnesota, 55902-9823, United States

Location

New York University

New York, New York, 10003, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Keystone Urology Specialists

Lancaster, Pennsylvania, 17604, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Spokane Urology

Spokane, Washington, 99202, United States

Location

Chonnam National University Hwasun Hospital

Hwasun, 58128, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Location

Severance Hospital

Sinchŏn-dong, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, 50612, South Korea

Location

Related Publications (1)

• Li R, Shah PH, Stewart TF, Nam JK, Bivalacqua TJ, Lamm DL, Uchio EM, Geynisman DM, Jacob JM, Meeks JJ, Dickstein R, Pearce SM, Kang SH, Jung SI, Kamat AM, Burke JM, Keegan KA, Steinberg GD. Oncolytic adenoviral therapy plus pembrolizumab in BCG-unresponsive non-muscle-invasive bladder cancer: the phase 2 CORE-001 trial. Nat Med. 2024 Aug;30(8):2216-2223. doi: 10.1038/s41591-024-03025-3. Epub 2024 Jun 6.

  PMID: 38844794 DERIVED

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms; Carcinoma in Situ

Interventions

pembrolizumab; dodecyl maltoside

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 13, 2020
• Study Start: December 8, 2020
• Primary Completion: March 7, 2023
• Study Completion: May 28, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (13); KR (6)