Status:
COMPLETED
Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin
Lead Sponsor:
CG Oncology, Inc.
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Non Muscle Invasive Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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)...
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 wit...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
December 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2024
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04387461
Start Date
December 8 2020
End Date
May 28 2024
Last Update
September 25 2024
Active Locations (19)
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1
University of California - San Diego
La Jolla, California, United States, 92093
2
University of California - Irvine
Orange, California, United States, 92868
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
4
Northwestern University
Tampa, Florida, United States, 33612