Phase 2 Study on the Safety and Effectiveness of Cretostimogene Grenadenorepvec for High-Risk Non-Muscle-Invasive Bladder Cancer

Program Overview

The study aims to find out if Cretostimogene Grenadenorepvec is safe and works well for treating high-risk non-muscle-invasive bladder cancer (NMIBC). Participants will receive the treatment in different ways to see which method is better. The treatment involves an initial course of weekly doses for six weeks, followed by additional courses if needed. If the cancer is under control, maintenance treatment will continue every three months in the first year and every six months in the second year, with an option to extend into a third year. Doctors will check the cancer status regularly using urine tests, bladder exams, and biopsies if necessary.

Description

In this study, up to 50 participants with high-risk non-muscle-invasive bladder cancer (NMIBC) will be enrolled. These participants have a specific type of bladder cancer called CIS, with or without other types of tumors, and have not received BCG treatment before. Participants will be divided into two groups to receive the treatment in different ways. The treatment includes a drug called Cretostimogene Grenadenorepvec and another substance called DDM, given weekly for six weeks. If the cancer is still present after three months, another course of treatment will be given. If the cancer is under control, maintenance treatment will continue every three months in the first year and every six months in the second year, with an option to extend into a third year. Doctors will monitor the cancer using urine tests, bladder exams, and biopsies if necessary, every three months for the first two years and then every six months for another two years or until the cancer returns.

Eligibility Criteria

Locations