Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin
Trial Parameters
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.
Eligibility Criteria
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 Patients who withdraw consent for these procedures will be withdrawn from the trial. 6.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.