Study on Enfortumab Vedotin and Pembrolizumab for Muscle-Invasive Bladder Cancer to Preserve the Bladder

Program Overview

This study focuses on people with muscle-invasive bladder cancer, where the cancer has spread into the bladder's muscle wall. Typically, treatment involves chemotherapy followed by surgery to remove the bladder, which can significantly impact a person's life. However, some people cannot undergo chemotherapy or do not want their bladder removed. This trial investigates if Enfortumab Vedotin combined with Pembrolizumab can help these patients keep their bladder. The main goals are to see how many people respond well to this treatment and how many can keep their bladder intact after two years.

Description

Participants in this study will receive Enfortumab Vedotin and Pembrolizumab through infusions. Enfortumab Vedotin will be given on the 1st and 8th day of each 3-week cycle, while Pembrolizumab will be administered on the 1st day of each cycle. Regular safety checks and tumor assessments will be conducted throughout the study.

Participants will continue receiving the treatment unless their cancer does not improve after 9 cycles, worsens, they cannot tolerate the treatment, they start another cancer treatment, or they or their doctor decide to stop. If the cancer worsens or does not improve after 9 cycles, surgery, radiotherapy, or chemotherapy may be needed.

After stopping the study treatment, participants will have regular health checks and scans every 12 weeks for the first two years, and every 24 weeks for up to five years if their cancer does not worsen. If the cancer progresses, no further scans will be done, but health checks will continue every three months by phone.

Eligibility Criteria

Locations