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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 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 808 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04700124
The ClinicalTrials.gov registry entry for NCT04700124 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 808 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04700124 reports 0 study locations.
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.
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