Phase 2 Study Evaluating Safety and Effectiveness of Cretostimogene Grenadenorepvec in Adults with High-Risk Non-Muscle-Invasive Bladder Cancer

What this Trial Is About

Researchers are evaluating the safety and efficacy of cretostimogene grenadenorepvec in participants with high-risk non-muscle-invasive bladder cancer NMIBC. This Phase 2, multi-arm, multi-cohort, open-label study includes participants who are either naive to Bacillus Calmette-Guerin BCG treatment, previously exposed to BCG, or unresponsive to BCG treatment. The study aims to compare different dosing methods and combinations with gemcitabine to better understand treatment effects in various NMIBC patient groups. The study is organized into several cohorts and arms based on the participants prior BCG treatment status and pathology. Cretostimogene grenadenorepvec is administered intravesically directly into the bladder using either the current or an alternative instillation method. In some arms, gemcitabine is also given either concurrently or sequentially with the study drug. Treatment involves weekly induction courses for six weeks, followed by reinduction if needed, and maintenance therapy over up to three years with treatments spaced every three to six months. Participants will undergo regular assessments including urine cytology, cystoscopy, upper tract evaluation, and biopsies or resections if indicated, every three months for the first two years and then every six months for up to four years or until disease recurrence. The study measures include complete response rates and high-grade event-free survival at various time points. Safety and duration of response are also monitored to evaluate the study treatments over the long term.

Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC