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NCT04700124 · ClinicalTrials.gov registry record · Phase 3
Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-Eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 808
- Enrollment target
NCT04700124: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT04700124 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 808 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04700124, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 808 participants
- Enrollment target
Study Summary
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).
Primary Outcome
EFS is defined as the time from randomization to the first occurrence of following events: radiographic disease progression precluding RC + PLND, failure to undergo surgery in participants with residual disease, gross residual disease left behind at time of surgery, local or distant recurrence based on blinded independent central review (BICR) or death due to any cause.
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Cisplatin
- DRUG Gemcitabine
- BIOLOGICAL Enfortumab vedotin (EV)
- PROCEDURE RC + PLND
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 808 participants |
| Start Date | 2021-04-21 |
| Est. Completion | 2025-10-27 |
| Phase | Phase 3 |
What the finished NCT04700124 record still lists
NCT04700124 is an interventional study that assigns participants to a tested intervention. The registered 808 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04700124 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04700124 about?
NCT04700124 is a clinical study titled "Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-Eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)". 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 \[gemcitabine plus cisplatin\] a...
What is the current status of trial NCT04700124?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 808 participants. The study started on 2021-04-21. Estimated completion is 2025-10-27.
What interventions are being tested in trial NCT04700124?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Cisplatin (DRUG), Gemcitabine (DRUG), Enfortumab vedotin (EV) (BIOLOGICAL), RC + PLND (PROCEDURE).
Who is sponsoring clinical trial NCT04700124?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04700124's enrollment target sits among peer trials
808 410th of 2000 higher than 1,590 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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