Trial Purpose

The purpose of this study is to assess the antitumor efficacy and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current standard of care (neoadjuvant chemotherapy [gemcitabine plus cisplatin] and RC + PLND) for participants with MIBC who are cisplatin-eligible. The primary hypothesis is perioperative EV and pembrolizumab and RC + PLND (Arm A) will achieve superior event free survival (EFS) compared with neoadjuvant gemcitabine + cisplatin and RC + PLND (Arm B).

View full trial information on Clinicaltrials.gov

CLINICALTRIALS.GOV IDENTIFIER:

NCT04700124

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

About The Trial

Trial Phase Icon

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.

Trial start Icon

Dates

  • Actual study start date April 21, 2021
  • Estimated primary completion date December 23, 2026
  • Estimated study completion date December 23, 2026

Eligibility

Conditions Icon

Conditions

Bladder Cancer

Age Range Icon

Age Range

18 - No Age Maximum

Sex Icon

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 Icon

Discuss With Your Doctor

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

CLINICALTRIALS.GOV IDENTIFIER:

NCT04700124

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.