This study aims to evaluate the efficacy and safety of Cretostimogene in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without Ta/T1 papillary tumors.
An open-label trial designed to evaluate Cretostimogene + DDM in patients with NMIBC who have failed prior BCG therapy. Single treatment arm that enrolled patients with carcinoma in situ with or without concomitant high-grade Ta or T1 papillary disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Engineered Oncolytic Adenovirus
Transduction-enhancing agent
Peking University First Hospital (First Clinical Medical School of Peking University)
Beijing, Beijing Municipality, China
RECRUITINGComplete response rate at any time in BCG-unresponsive high-risk NMIBC with or without Ta/T1 papillary tumors including CIS
Time frame: 36 months
Duration of response (DOR)
Time from first documented objective response to disease progression or death from any cause.
Time frame: 36 months
Assess high-grade reoccurrence free survival (RFS)
Time from first treatment to first recurrence of high-grade disease or death from any cause.
Time frame: 36 months
Assess progression free survival (PFS)
Time from first treatment to tumor progression or death from any cause.
Time frame: 36 months
Complete response rate at 12, 24, and 36 months
Proportion of patients achieving complete response at 12, 24, and 36 months.
Time frame: Assessed at 12, 24, and 36 months
Overall survival rate at 36 months
Proportion of patients alive at 36 months.
Time frame: 36 months
Safety: incidence and severity of adverse events (AE) and serious adverse events (SAE)
Safety is evaluated based on NCI-CTCAE v5.0 criteria. This includes incidence and severity of all adverse events (AE), serious adverse events (SAE), and abnormal laboratory values.
Time frame: 36 months
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RECRUITING...and 4 more locations