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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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 Patients who withdraw consent for these procedures will be withdrawn from the trial.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.
Primary outcome measure(s)
Complete response rate at any time in BCG-unresponsive high-risk NMIBC with or without Ta/T1 papillary tumors including CIS — 36 months
Trial sites (14)
Facility
City
Region
Status
Peking University First Hospital (First Clinical Medical School of Peking University)
Beijing
Beijing Municipality
Recruiting
Chongqing University Cancer Hospital
Chongqing
Chongqing Municipality
Recruiting
Fujian Cancer Hospital
Fuzhou
Fujian
Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Hubei
Recruiting
Hunan Cancer Hospital
Changsha
Hunan
Recruiting
The Affiliated Drum Tower Hospital of Nanjing University Medical School
Nanjing
Jiangsu
Recruiting
The First Hospital of China Medical University
Shenyang
Liaoning
Recruiting
Qilu Hospital of Shandong University
Jinan
Shandong
Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Shanghai Municipality
Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Shanghai Municipality
Recruiting
West China Hospital, Sichuan University
Chengdu
Sichuan
Recruiting
The Second Hospital of Tianjin Medical University
Tianjin
Tianjin Municipality
Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
Zhejiang
Recruiting
The First Affiliated Hospital of Wenzhou Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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