Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin (CORE-001)
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| ClinicalTrials.gov Identifier: NCT04387461 |
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Recruitment Status :
Active, not recruiting
First Posted : May 13, 2020
Last Update Posted : August 24, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non Muscle Invasive Bladder Cancer | Biological: CG0070 Biological: Pembrolizumab Injection Other: n-dodecyl-B-D-maltoside | Phase 2 |
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 (Clinical Trial) |
| Actual Enrollment : | 35 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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) |
| Actual Study Start Date : | December 8, 2020 |
| Estimated Primary Completion Date : | June 2023 |
| Estimated Study Completion Date : | June 2023 |
| Arm | Intervention/treatment |
|---|---|
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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. |
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 |
- 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.
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Pathologically confirmed NMIBC with CIS (with or without Ta/T1 disease)
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04387461
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| Principal Investigator: | James Burke | CG Oncology, Inc. |
| Responsible Party: | CG Oncology, Inc. |
| ClinicalTrials.gov Identifier: | NCT04387461 |
| Other Study ID Numbers: |
CG2003C Mk3475 Keynote 935 ( Other Identifier: Merck ) |
| First Posted: | May 13, 2020 Key Record Dates |
| Last Update Posted: | August 24, 2022 |
| Last Verified: | June 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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high-grade Ta papillary disease high-grade T1 papillary disease carcinoma in situ Bacillus-Calmette-Guerin Unresponsive |
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Urinary Bladder Neoplasms Non-Muscle Invasive Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Urinary Bladder Diseases |
Urologic Diseases Male Urogenital Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Pembrolizumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |