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NCT03924856 · ClinicalTrials.gov registry record · Phase 3
Perioperative Pembrolizumab (MK-3475) Plus Neoadjuvant Chemotherapy Versus Perioperative Placebo Plus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle-invasive Bladder Cancer (MIBC) (MK-3475-866/KEYNOTE-866)
A Phase 3 study of Bladder Cancer, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 3
- Development phase
- 907
- Enrollment target
- 20
- Study locations
NCT03924856: Active Phase 3 study of Bladder Cancer, sponsored by Merck Sharp & Dohme.
NCT03924856 is a Phase 3 study of Bladder Cancer that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 907 participants, below the 12,749-participant average among 175 other Bladder Cancer trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03924856, a Phase 3 study of Bladder Cancer, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 907 participants
- Enrollment target
- 20
- Study locations
Study Summary
A global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients.
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 RC surgery; failure to undergo RC surgery in participants with residual disease and any radiographical disease present; gross residual disease left behind at the time of surgery; local or distant recurrence based on investigator assessments and/or biopsy, or death due to any cause.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Placebo
- DRUG Cisplatin
- DRUG Gemcitabine
- PROCEDURE Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])
Study Locations (20)
California
- Scripps MD Anderson ( Site 0010) - La Jolla
- Providence Saint John's Health Center ( Site 0075) - Santa Monica
Indiana
- Parkview Cancer Institute ( Site 0077) - Fort Wayne
- Indiana University Melvin and Bren Simon Cancer Center ( Site 0004) - Indianapolis
Texas
- MD Anderson Cancer Center ( Site 0063) - Houston
- Central Texas Veterans Healthcare System ( Site 0057) - Temple
District of Columbia
- Georgetown University Medical Center ( Site 0022) - Washington D.C.
Florida
- AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0005) - Orlando
Louisiana
- Ochsner Medical Center ( Site 0049) - New Orleans
Maine
- New England Cancer Specialists ( Site 0070) - Scarborough
Massachusetts
- UMass Memorial Medical Center ( Site 0051) - Worcester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 907 participants |
| Start Date | 2019-06-13 |
| Est. Completion | 2026-09-01 |
| Phase | Phase 3 |
What the registry record for NCT03924856 still lists
NCT03924856 is an interventional study that assigns participants to a tested intervention. The registered 907 participants enrollment target is mid-sized for trials with a published cap, below the 12,749-participant average among 175 other Bladder Cancer trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Bladder Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT03924856 names 20 study sites across 17 states, led by California, Indiana, Texas.
Frequently Asked Questions
What is clinical trial NCT03924856 about?
NCT03924856 is a clinical study titled "Perioperative Pembrolizumab (MK-3475) Plus Neoadjuvant Chemotherapy Versus Perioperative Placebo Plus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle-invasive Bladder Cancer (MIBC) (MK-3475-866/KEYNOTE-866)". A global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients.
What is the current status of trial NCT03924856?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 907 participants. The study started on 2019-06-13. Estimated completion is 2026-09-01.
What conditions does trial NCT03924856 study?
This clinical trial studies the following conditions: Bladder Cancer.
What interventions are being tested in trial NCT03924856?
The interventions under investigation include: Pembrolizumab (DRUG), Placebo (DRUG), Cisplatin (DRUG), Gemcitabine (DRUG), Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND]) (PROCEDURE).
Who is sponsoring clinical trial NCT03924856?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03924856 being conducted?
This trial has 20 study locations across California, District of Columbia, Florida, Indiana, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bladder Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03924856's enrollment target sits among peer trials
907 19th of 175 higher than 157 of 175 other Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bladder Cancer 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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A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
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A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer
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