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)
Condition: Biliary Tract Carcinoma
MeSH terms: Carcinoma
Intervention: Pembrolizumab; Gemcitabine; Cisplatin; Placebo
Intervention description: Pembrolizumab by intravenous (IV) infusion; Gemcitabine by IV infusion; Cisplatin by IV infusion; Placebo to pembrolizumab
Intervention MeSH terms: Cisplatin; Gemcitabine; Pembrolizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1069.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Programmed cell death 1 (PD-1); Pembrolizumab; Cholangiocarcinoma; Gallbladder cancer; Checkpoint inhibitor; Immunotherapy; Biliary; Keytruda; Bile Duct Cancer

Summary:

      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).
    

Eligibility criteria:

        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)

          -  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