Perioperative Pembrolizumab Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer

Trial Information
Eligibility
Locations

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.

View full trial information on Clinicaltrials.gov

CLINICALTRIALS.GOV IDENTIFIER:

NCT03924895

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

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

Phase 3

Tests the medicine or vaccine in approximately 1,000 to 5,000 volunteers. 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.

Dates

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

Eligibility

Conditions

Urinary Bladder Cancer, Muscle-invasive

Age Range

18 - No Age Maximum

Sex

All

Trial locations

What Can You Do Next?

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

Discuss With Your Doctor

Print this page or email it to your doctor to discuss at your next visit.

CLINICALTRIALS.GOV IDENTIFIER:

NCT03924895

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

Participating in a clinical trial is an important decision.

Anyone participating in a trial should know as much as possible about what is being studied, what risks are involved and what potential benefits may be gained before deciding to enroll. If you are interested in participating in a clinical trial, please talk to your doctor first.