High-grade Ta/ T1 Papillary Disease Bladder Cancer, 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
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.
Detailed description
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.
Interventions
BIOLOGICALCretostimogene Grenadenorepvec
Engineered Oncolytic Adenovirus
Transduction-enhancing agent
Sponsors
Lepu Biopharma Co., Ltd.
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
In order to be eligible for participation in this trial, the patient must: 1. Be ≥18 years of age on day of signing informed consent. \- Patients must have pathologically confirmed BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without concomitant Ta/T1 papillary disease. 2. Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 3. Have all Ta and/or T1 disease resected and all CIS resected or fulgurated, as feasible, prior to study treatment. 4. Demonstrate adequate organ function. 5. Patients must be willing to comply with study mandated cystoscopies, urine cytology, urograms, biopsies, and other procedures (including TURBT or other resection for all Ta/T1 disease) for the duration of the study. Patients who withdraw consent for these procedures will be withdrawn from the trial. 6. Ineligible to receive radical cystectomy or refusal of radical cystectomy according to Investigator assessment.
Exclusion criteria
1. Has current or past history of muscle invasive (T2 or higher stage) or locally advanced (T3/T4, any N) or metastatic bladder cancer. 2. History of urothelial carcinoma in the upper genitourinary tract (kidney, renal collecting system, ureter) or in the prostatic urethra, including urethral CIS, within 24 months prior to enrollment. 3. Has received systemic anti-cancer therapy, including investigational agents. 4. Has had prior systemic treatment (with the exception of checkpoint inhibitor therapy), radiation therapy, or surgery for bladder cancer other than TURBT or bladder biopsies. 5. Has any of the following within the 6 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident, pulmonary embolus, uncontrolled hypertension, or uncontrolled congestive heart failure. 6. Cannot tolerate study-related biopsies, IVE administration, or 1-hour bladder hold of Cretostimogene.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate at any time in BCG-unresponsive high-risk NMIBC with or without Ta/T1 papillary tumors including CIS | 36 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of response (DOR) | 36 months | Time from first documented objective response to disease progression or death from any cause. |
| Assess high-grade reoccurrence free survival (RFS) | 36 months | Time from first treatment to first recurrence of high-grade disease or death from any cause. |
| Assess progression free survival (PFS) | 36 months | Time from first treatment to tumor progression or death from any cause. |
| Complete response rate at 12, 24, and 36 months | Assessed at 12, 24, and 36 months | Proportion of patients achieving complete response at 12, 24, and 36 months. |
| Overall survival rate at 36 months | 36 months | Proportion of patients alive at 36 months. |
| Safety: incidence and severity of adverse events (AE) and serious adverse events (SAE) | 36 months | 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. |
Countries
China
Contacts
CONTACTProgram Director
PRINCIPAL_INVESTIGATORDinɡwei Ye, M.D.
Fudan University
Outcome results
None listed