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)

Completed · Phase 3 · Has a placebo group

Conditions studied: Biliary Tract Carcinoma

In brief

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).

Key facts

Study ID

NCT04003636

Run by

Merck Sharp & Dohme LLC

People needed

1069

Starts

2019-09-24

Expected to finish

2025-04-01

Last updated by the study team

2026-03-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer)
• Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as determined by the site investigator
• Participants with a history of hepatitis B or hepatitis C can be enrolled if they meet study criteria
• Is able to provide archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion
• Has a life expectancy of greater than 3 months
• Has adequate organ function

You may not qualify if…

• Has had previous systemic therapy for advanced (metastatic) or unresectable (locally advanced) biliary tract cancer (intra-or extra hepatic cholangiocarcinoma or gallbladder cancer)
• Has ampullary cancer
• Has small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology and/or mucinous cystic neoplasms
• Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti- programmed cell death ligand 1 or 2 (anti-PD-L1, anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137)
• Has a known history of, or any evidence of, central nervous system (CNS) metastases and/or carcinomatous meningitis, as assessed by local site investigator
• Has had an allogenic tissue/solid organ transplant

Where it is running

• University of California San Diego Moores Cancer Center ( Site 0008) — La Jolla, California, United States
• UCLA Hematology/Oncology - Santa Monica ( Site 0014) — Los Angeles, California, United States
• University of California - San Francisco ( Site 0030) — San Francisco, California, United States
• University of Colorado Hospital ( Site 0011) — Aurora, Colorado, United States
• Hartford Hospital ( Site 0057) — Hartford, Connecticut, United States
• Yale University ( Site 0053) — New Haven, Connecticut, United States
• Winship Cancer Institute of Emory University ( Site 0013) — Atlanta, Georgia, United States
• Northwest Georgia Oncology Centers PC ( Site 0045) — Marietta, Georgia, United States
• Decatur Memorial Hospital ( Site 0056) — Decatur, Illinois, United States
• Winthrop University Hospital ( Site 0059) — Mineola, New York, United States
• Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0038) — New York, New York, United States
• Columbia University/Herbert Irving Cancer Center ( Site 0009) — New York, New York, United States
• University of Oklahoma- Stephenson Oklahoma Cancer Center ( Site 0055) — Oklahoma City, Oklahoma, United States
• OHSU Center for Health & Healing ( Site 0044) — Portland, Oregon, United States
• Charleston Oncology ( Site 0042) — Charleston, South Carolina, United States
• Saint Francis Health System ( Site 0051) — Greenville, South Carolina, United States
• Blue Ridge Cancer Care ( Site 0033) — Roanoke, Virginia, United States
• CEMIC ( Site 0581) — Buenos Aires, Buenos Aires F.D., Argentina
• Fundacion Favaloro ( Site 0578) — Ciudad de Buenos Aires, Buenos Aires F.D., Argentina
• Centro Medico San Roque ( Site 0579) — San Miguel de Tucumán, Tucumán Province, Argentina
• Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0580) — CABA, Argentina
• Centro Oncologico Riojano Integral ( Site 0584) — La Rioja, Argentina
• Liverpool Hospital ( Site 0707) — Liverpool, New South Wales, Australia
• Mid North Coast Cancer Institute ( Site 0708) — Port Macquarie, New South Wales, Australia
• University of Alabama at Birmingham Comprehensive Cancer Ctr ( Site 0016) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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