Trial Purpose

This is a study of perioperative pembrolizumab or enfortumab vedotin in combination with pembrolizumab in participants who are cisplatin-ineligible or decline cisplatin with muscle-invasive bladder cancer (MIBC).

The primary hypothesis is that perioperative pembrolizumab plus radical cystectomy (RC) plus pelvic lymph node dissection (PLND) and perioperative enfortumab vedotin in combination with pembrolizumab plus RC+PLND will achieve superior pathologic complete response (pCR) rates (based on central pathologic review) and event-free survival (EFS) compared with RC+PLND alone.

With Amendment 5, outcome measures for programmed cell death ligand 1 (PD-L1) combined positive score (CPS) were removed.

Learn More on



When speaking to your doctor, please have the trial identifier number available.

About The Study

All patients who enrol in the trial will receive medication while on the study.

33% will receive pembrolizumab before and after surgery

33% will receive standard of care surgery only

33% will receive pembrolizumab along with enfortumab vedotin before and after surgery

Trial Phase Icon

Phase 3

Tests the medicine or vaccine in large groups of trial participants (from several hundred to several thousand). For medicines, volunteers have the disease or condition the medicine is designed to treat. In vaccine studies, the volunteers may be healthy or have diseases or conditions. Phase 3 trials take place in hospitals, clinics, or physician offices.

Trial start Icon


  • Actual study start date 24 July 2019
  • Estimated primary completion date 31 May 2027
  • Estimated study completion date 15 December 2027


Only a qualified healthcare professional can determine your eligibility. However, this information may be useful in starting a conversation with your doctor.

Conditions Icon


Urinary Bladder Cancer, Muscle-invasive

Age Range Icon

Age Range

18 - No Age Maximum

Sex Icon



Trial locations

Locations provided may not reflect the most current site information. Please call the number provided in the location results to confirm.