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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)

Trial Status: Active

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 study has 2 primary hypotheses: 1. Pembrolizumab plus gemcitabine / cisplatin is superior to placebo plus gemcitabine / cisplatin with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR) and 2. Pembrolizumab plus gemcitabine / cisplatin is superior to placebo plus gemcitabine / cisplatin with respect to overall survival (OS).

Inclusion Criteria

  • 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

Exclusion Criteria

  • Has had previous systemic therapy for advanced (metastatic) or unresectable (locally advanced) biliary tract cancer (intra-or extra hepatic cholangiocarcinoma or gallbladder cancer), with the exception of adjuvant therapy which is allowed
  • 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 co-inhibitory 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


University of Alabama at Birmingham Cancer Center
Status: ACTIVE
Contact: Olumide B Gbolahan
Phone: 205-731-9701


San Francisco
UCSF Medical Center-Mount Zion
Status: ACTIVE
Contact: Helen Diller Family Comprehensive Cancer Center
Phone: 877-827-3222


University of Colorado Hospital
Status: ACTIVE


Emory University Hospital / Winship Cancer Institute
Status: ACTIVE
Emory University Hospital Midtown
Status: ACTIVE

New York

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: ACTIVE
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ACTIVE


Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE


OHSU Knight Cancer Institute
Status: ACTIVE

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Merck and Company Inc

  • Primary ID 3475-966
  • Secondary IDs NCI-2019-05779, 195007, 2019-000944-82, MK-3475-966, KEYNOTE-966
  • ID NCT04003636