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)
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a 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. The primary hypothesis is pembrolizumab plus gemcitabine/cisplatin is superior to placebo plus gemcitabine/cisplatin with respect to overall survival (OS).
Study identification
- NCT ID
- NCT04003636
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,069 participants
Conditions and interventions
Conditions
Interventions
- Pembrolizumab Biological
- Gemcitabine Drug
- Cisplatin Drug
- Placebo Drug
Biological · Drug
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 24, 2019 (Actual)
- Primary completion
- Dec 15, 2022 (Actual)
- Completion
- Apr 1, 2025 (Actual)
- Last update posted
- Mar 24, 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 24, 2026 · Synced Oct 30, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04003636 live on ClinicalTrials.gov.