ClinicalTrials.gov record
Completed Phase 3 Interventional Results available

Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)

ClinicalTrials.gov ID: NCT04003636

Public ClinicalTrials.gov record NCT04003636. 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 19, 2026, 6:25 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 of Pembrolizumab Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants With Advanced and/or Unresectable Biliary Tract Carcinoma

Study identification

NCT ID
NCT04003636
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Enrollment
1,069 participants

Conditions and interventions

Interventions

  • Cisplatin Drug
  • Gemcitabine Drug
  • Pembrolizumab Biological
  • Placebo Drug

Drug · Biological

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
Sep 23, 2019
Primary completion
Dec 14, 2022
Completion
Mar 31, 2025
Last update posted
Mar 23, 2026

2019 – 2025

United States locations

U.S. sites
18
U.S. states
11
U.S. cities
17
Facility City State ZIP Site status
University of Alabama at Birmingham Comprehensive Cancer Ctr ( Site 0016) Birmingham Alabama 35294
University of California San Diego Moores Cancer Center ( Site 0008) La Jolla California 92093-0698
UCLA Hematology/Oncology - Santa Monica ( Site 0014) Los Angeles California 90404
University of California - San Francisco ( Site 0030) San Francisco California 94158
University of Colorado Hospital ( Site 0011) Aurora Colorado 80045
Hartford Hospital ( Site 0057) Hartford Connecticut 06102
Yale University ( Site 0053) New Haven Connecticut 06510
Winship Cancer Institute of Emory University ( Site 0013) Atlanta Georgia 30322-1013
Northwest Georgia Oncology Centers PC ( Site 0045) Marietta Georgia 30060
Decatur Memorial Hospital ( Site 0056) Decatur Illinois 62526
Winthrop University Hospital ( Site 0059) Mineola New York 11501
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0038) New York New York 10016
Columbia University/Herbert Irving Cancer Center ( Site 0009) New York New York 10032
University of Oklahoma- Stephenson Oklahoma Cancer Center ( Site 0055) Oklahoma City Oklahoma 73104
OHSU Center for Health & Healing ( Site 0044) Portland Oregon 97239
Charleston Oncology ( Site 0042) Charleston South Carolina 29414
Saint Francis Health System ( Site 0051) Greenville South Carolina 29607
Blue Ridge Cancer Care ( Site 0033) Roanoke Virginia 24014

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 167 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04003636, 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 Mar 23, 2026 · Synced May 19, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04003636 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →