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NCT03924895 · ClinicalTrials.gov registry record · Phase 3
Perioperative Pembrolizumab (MK-3475) 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 (MK-3475-905/KEYNOTE-905/EV-303)
A Phase 3 study of Urinary Bladder Cancer, Muscle-invasive, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 3
- Development phase
- 595
- Enrollment target
- 20
- Study locations
NCT03924895: Active Phase 3 study of Urinary Bladder Cancer, Muscle-invasive, sponsored by Merck Sharp & Dohme.
NCT03924895 is a Phase 3 study of Urinary Bladder Cancer, Muscle-invasive that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 595 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03924895, a Phase 3 study of Urinary Bladder Cancer, Muscle-invasive, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 595 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
EFS is defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes radical cystectomy + pelvic lymph node dissection (RC + PLND) surgery, failure to undergo RC + PLND surgery in participants with residual disease and any radiographic disease present (biopsy-proven muscle-invasive bladder cancer \[MIBC\] will be considered an event regardless of radiographic findings), gross residual disease left behind at the time of surger
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Enfortumab Vedotin
- PROCEDURE Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])
Study Locations (20)
California
- St. Joseph Heritage Healthcare ( Site 0046) - Fullerton
- Scripps MD Anderson ( Site 0010) - La Jolla
- Hoag Memorial Hospital Presbyterian ( Site 1595) - Newport Beach
- John Wayne Cancer Institute ( Site 0075) - Santa Monica
Illinois
- John H. Stroger Jr. Hospital of Cook County ( Site 1551) - Chicago
- University of Chicago ( Site 0068) - Chicago
Indiana
- Parkview Cancer Institute ( Site 0077) - Fort Wayne
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center ( Site 0004) - Indianapolis
Alabama
- University of South Alabama, Mitchell Cancer Institute ( Site 1582) - Mobile
Arkansas
- CARTI Cancer Center ( Site 1577) - Little Rock
Colorado
- University of Colorado Hospital ( Site 0098) - Aurora
District of Columbia
- Georgetown University Medical Center ( Site 0022) - Washington D.C.
Georgia
- Emory School of Medicine ( Site 0006) - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 595 participants |
| Start Date | 2019-07-24 |
| Est. Completion | 2027-12-15 |
| Phase | Phase 3 |
What the registry record for NCT03924895 still lists
NCT03924895 is an interventional study that assigns participants to a tested intervention. The registered 595 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% lower).
The record links to 1 condition, with Urinary Bladder Cancer, Muscle-invasive appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03924895 names 20 study sites across 15 states, led by California, Illinois, Indiana.
Frequently Asked Questions
What is clinical trial NCT03924895 about?
NCT03924895 is a clinical study titled "Perioperative Pembrolizumab (MK-3475) 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 (MK-3475-905/KEYNOTE-905/EV-303)". 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...
What is the current status of trial NCT03924895?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 595 participants. The study started on 2019-07-24. Estimated completion is 2027-12-15.
What conditions does trial NCT03924895 study?
This clinical trial studies the following conditions: Urinary Bladder Cancer, Muscle-invasive.
What interventions are being tested in trial NCT03924895?
The interventions under investigation include: Pembrolizumab (DRUG), Enfortumab Vedotin (DRUG), Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND]) (PROCEDURE).
Who is sponsoring clinical trial NCT03924895?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03924895 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03924895's enrollment target sits among peer trials
595 640th of 2000 higher than 1,360 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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