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

Phase 2

• Conditions: Non Muscle Invasive Bladder Cancer
• Interventions: Biological: CG0070; Biological: Pembrolizumab Injection; Other: n-dodecyl-B-D-maltoside

• Registration Number: NCT04387461
• Lead Sponsor: CG Oncology, Inc.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-05-12
• Study First Posted: 2020-05-13
• Study Start: 2020-12-08
• Status Verified: 2022-06
• Last Update Submitted: 2022-08-22
• Last Update Posted: 2022-08-24
• Primary Completion: 2023-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	CG0070	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.
Single Arm	Pembrolizumab Injection	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.
Single Arm	n-dodecyl-B-D-maltoside	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.

Primary Outcome Measures

Name	Time	Method
Complete response rate in patients	12 months	Percentage of patients with a complete response as defined by FDA guidance document dated February 2018 for NMIBC.

Secondary Outcome Measures

Name	Time	Method
Median progression free survival	12 months	Median duration of progression free survival of patients
Median duration of response (DoR)	12 months	Median duration of response in patients with a CR or PR
Incidence of adverse events when CG0070 administered intravesically when combined with pembrolizumab.	12 months	Percentage of patients with adverse events by grade as determined by NCI CTCAE v5.0
Median overall survival (OS)	12 months	Median overall survival in months in patients

Trial Locations

Locations (19)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

Northwestern University; 🇺🇸 Tampa, Florida, United States

Johns Hopkins Medical Institution; 🇺🇸 Baltimore, Maryland, United States

Mayo Clinic - Rochester; 🇺🇸 Rochester, Minnesota, United States

SUNY Upstate Medical University; 🇺🇸 Syracuse, New York, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

University of California - Irvine; 🇺🇸 Orange, California, United States

University of California - San Diego; 🇺🇸 La Jolla, California, United States

Chesapeake Urology; 🇺🇸 Hanover, Maryland, United States

New York University; 🇺🇸 New York, New York, United States

Keystone Urology Specialists; 🇺🇸 Lancaster, Pennsylvania, United States

Chonnam National University Hwasun Hospital; 🇰🇷 Hwasun, Korea, Republic of

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of

Spokane Urology; 🇺🇸 Spokane, Washington, United States

Severance Hospital; 🇰🇷 Sinchon-dong, Korea, Republic of

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, 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