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|
Recruitment Status : Recruiting
First Posted : May 13, 2020
Last Update Posted : July 22, 2021
|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)|
|Estimated Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||December 2021|
|Estimated Study Completion Date :||June 2022|
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.
Engineered Oncolytic Adenovirus
Biological: Pembrolizumab Injection
Immune checkpoint inhibitor, Monoclonal antibody
Other Name: Keytruda
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
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
|Contact: Stephanie Harris||(949)-firstname.lastname@example.org|
|Principal Investigator:||James Burke||CG Oncology, Inc.|