A Phase 3 Randomized Study of Adjuvant Cretostimogene Grenadenorepvec versus Observation for the Treatment of Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR-NMIBC) Following Transurethral Resection of Bladder Tumor (TURBT)
Brief description of study
This is a study that looks at how well a treatment called cretostimogene works after a procedure called TURBT for patients with intermediate-risk non-muscle invasive bladder cancer (IR-NMIBC). After doctors confirm the diagnosis and remove the tumor, patients will be randomly placed into two groups: one group will receive cretostimogene after TURBT, while the other group will just be observed. For the first two years, doctors will check patients' health every three months using urine tests, complete bladder checks, and, if needed, extra procedures to look for any cancer cells. Each year, patients will also have a special scan called a CT urogram or MRU. After two years, checks will happen every six months for another year. If patients in the observation group have a recurrence, they will be offered the treatment with cretostimogene like the first group. Patients in the treatment group who have a recurrence will stop their study treatment and will be watched for how long they live and will receive regular care from their doctor. Patients in the treatment group will take cretostimogene every three months for up to 13 months if they don’t have any recurrence of the disease. Throughout the study, all imaging and checks must be done in the same way.
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