Phase 2 trial of enfortumab vedotin plus pembrolizumab with selective bladder sparing for treatment of muscle-invasive urothelial cancer of the bladder: HCRN GU22-598

The purpose of this study is to see if the combination of enfortumab vedotin and pembrolizumab leads to no detectable cancer on early assessments of the bladder after initial treatment. We are asking you to take part in this research study because you have muscle-invasive bladder cancer. This combination of enfortumab vedotin and pembrolizumab has been tested in people and is approved by the U.S. Food and Drug Administration (FDA) to treat patients with bladder cancer that has spread outside of the bladder (also known as metastatic bladder cancer).Enfortumab vedotin and Pembrolizumab are not FDA approved to treat your type of bladder cancer (muscle-invasive urothelial cancer of the bladder).

Are you Eligible? (Inclusion Criteria)

• Age ≥18 years - Deemed eligible to undergo curative-intent radical cystectomy - Have undergone maximal TURBT ≤ 60 days prior to enrollment or willing to undergo maximal TURBT unless deemed unfeasible by the treating investigator