Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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)
NCT03924856 · View on ClinicalTrials.gov ↗
Study Summary
A global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients.
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 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03924856
The ClinicalTrials.gov registry entry for NCT03924856 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 907 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03924856 reports 20 study locations spanning 17 distinct geographic areas — top geographies include California, Indiana, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03924856?
This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.