ClinicalTrials.gov record
Active, not recruiting Phase 3 Interventional

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)

ClinicalTrials.gov ID: NCT03924856

Public ClinicalTrials.gov record NCT03924856. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 12, 2026, 8:03 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Randomized, Double-blind Study to Evaluate Perioperative Pembrolizumab (MK-3475) + Neoadjuvant Chemotherapy Versus Perioperative Placebo + Neoadjuvant Chemotherapy in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-866)

Study identification

NCT ID
NCT03924856
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Enrollment
907 participants

Conditions and interventions

Conditions

Interventions

  • Cisplatin Drug
  • Gemcitabine Drug
  • Pembrolizumab Drug
  • Placebo Drug
  • Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND]) Procedure

Drug · Procedure

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 12, 2019
Primary completion
Jan 25, 2026
Completion
Aug 31, 2026
Last update posted
Aug 27, 2025

2019 – 2026

United States locations

U.S. sites
24
U.S. states
20
U.S. cities
24
Facility City State ZIP Site status
Scripps MD Anderson ( Site 0010) La Jolla California 92037
Providence Saint John's Health Center ( Site 0075) Santa Monica California 90404
Georgetown University Medical Center ( Site 0022) Washington D.C. District of Columbia 20007
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0005) Orlando Florida 32804
Parkview Cancer Institute ( Site 0077) Fort Wayne Indiana 46845
Indiana University Melvin and Bren Simon Cancer Center ( Site 0004) Indianapolis Indiana 46202
Ochsner Medical Center ( Site 0049) New Orleans Louisiana 70121
New England Cancer Specialists ( Site 0070) Scarborough Maine 04074
UMass Memorial Medical Center ( Site 0051) Worcester Massachusetts 01655
Henry Ford Hospital ( Site 0039) Detroit Michigan 48202
Mercy Hospital Saint Louis ( Site 0064) St Louis Missouri 63141
Morristown Medical Center ( Site 0015) Morristown New Jersey 07960
UNM Comprehensive Cancer Center-Clinical Research Office ( Site 0045) Albuquerque New Mexico 87106
New York University Perlmutter Cancer Center ( Site 0008) New York New York 10016
University Hospitals Cleveland Medical Center ( Site 0038) Cleveland Ohio 44106
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0021) Tulsa Oklahoma 74146
Portland VA Medical Center ( Site 0084) Portland Oregon 97239
Allegheny General Hospital ( Site 0048) Pittsburgh Pennsylvania 15212
MD Anderson Cancer Center ( Site 0063) Houston Texas 77030
Central Texas Veterans Healthcare System ( Site 0057) Temple Texas 76504
Inova Schar Cancer Institute ( Site 0007) Fairfax Virginia 22031
Northwest Medical Specialties, PLLC ( Site 0061) Puyallup Washington 98373
Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0033) Seattle Washington 98109
Charleston Area Medical Center ( Site 0023) Charles Town West Virginia 25304

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 151 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03924856, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 27, 2025 · Synced May 12, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03924856 live on ClinicalTrials.gov.

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