An Open-label, Single-Arm Study Evaluating Enfortumab Vedotin Plus Pembrolizumab for Bladder Preservation in Muscle-invasive Bladder Cancer

What this Trial Is About

This research investigates a treatment for adults with muscle-invasive bladder cancer, a condition where cancer has grown into the muscle wall of the bladder. Standard care involves chemotherapy followed by surgery to remove the bladder, which can cause significant long-term changes. This trial studies enfortumab vedotin combined with pembrolizumab as a possible alternative for people who are able to have surgery but may benefit from preserving their bladder. The goal is to see how many participants keep responding well to this treatment and retain their bladder after two years. Participants will receive intravenous infusions of enfortumab vedotin on days 1 and 8 of each 21-day cycle, along with pembrolizumab on day 1 of every cycle. Treatment continues unless the cancer worsens after 9 cycles, side effects prevent continuation, or other treatments begin. If cancer progresses, options such as bladder surgery, radiotherapy, or chemotherapy may be considered. This study is open-label, single-arm, and phase 2, focusing on bladder preservation during treatment. Throughout the study, participants will have safety checks at each visit, including tumor assessments at some visits. After stopping study treatment, participants will attend follow-up visits for health evaluations and medical problem monitoring. Scans will be done every 12 weeks for the first two years, then every 24 weeks for up to five years unless cancer worsens. After progression, participants will have health checks by telephone every three months. The study includes evaluations of clinical response, bladder-intact survival, overall survival, and adverse events.

A Study to Find Out if Enfortumab Vedotin Given With Pembrolizumab Helps People With Muscle-invasive Bladder Cancer Keep Their Bladder