Non Muscle Invasive Bladder Cancer
Conditions
Keywords
high-grade Ta papillary disease, high-grade T1 papillary disease, carcinoma in situ, Bacillus-Calmette-Guerin Unresponsive
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.
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.
Interventions
BIOLOGICALCG0070
Engineered Oncolytic Adenovirus
BIOLOGICALPembrolizumab Injection
Immune checkpoint inhibitor, Monoclonal antibody
Transduction-enhancing agent.
Sponsors
Merck Sharp & Dohme LLC
CG Oncology, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 duration of response (DoR) | 12 months | Median duration of response in patients with a CR or PR |
| Median overall survival (OS) | 12 months | Median overall survival in months in patients |
| Median progression free survival | 12 months | Median duration of progression free survival of patients |
Countries
South Korea, United States
Outcome results
None listed