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 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.

With Amendment 8, the primary outcome measure of pathologic complete response (pCR) rates was changed to a secondary outcome measure.

View full trial information on Clinicaltrials.gov

CLINICALTRIALS.GOV IDENTIFIER

NCT03924895

EudraCT Number

2018-003809-26

EU CT Number

2023-504932-16

When you talk with your doctor or clinical trial team member, please have the trial identifier number available.

Resources

Eligibility

Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial. However, this information may be useful in starting a conversation with your doctor.

Conditions Icon

Conditions

Urinary Bladder Cancer, Muscle-invasive

Age Range Icon

Age Range

18+

Sex Icon

Sex

All

About the trial

All patients who enroll 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 Current trial phase

Trial Phase 3

In Phase 3 trials, researchers try to find out if a treatment works in a large number of people, usually about 1,000 to 5,000 participants who have the health condition the treatment is intended to treat. In vaccine trials, the participants may be healthy or have diseases or conditions. Phase 3 trials may happen in a doctor’s office, a clinic, or a hospital.

Trial start Icon Trial start and end dates
  • Trial start date July 24, 2019
  • Estimated primary completion date May 31, 2027
  • Estimated trial completion date December 15, 2027

Trial locations

Sorry, there are no locations found.

What can you do next?

If you think this clinical trial might be a good fit and you are interested in taking part, take the next step to see if you are eligible.

Discuss with your doctor or care team

Print this page with details about the trial or email it to your doctor to discuss the clinical trial during your next visit.

Get help talking with your doctor or care team

CLINICALTRIALS.GOV IDENTIFIER

NCT03924895

EudraCT Number

2018-003809-26

EU CT Number

2023-504932-16

When you talk with your doctor or clinical trial team member, please have the trial identifier number available.

Taking part in a clinical trial is an important decision

If you are considering joining a clinical trial, first learn as much as you can about:

  • The investigational treatment that is being studied
  • What the risks and possible benefits are for participants

Talk to your doctor about the clinical trial before you decide to join.

Read our “What to Consider” page for more questions to ask and think about