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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) (KEYNOTE-966)

Study Name
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) (KEYNOTE-966)
ClinicalTrials.gov Identifier (if applicable)
NCT04003636
Clinical Trial Category (check all that apply)
  • First Line Therapy
  • Chemotherapy
  • Immunotherapy
Study Center
Institution Name
Merck Sharp & Dohme Corp.
Institution Address
2000 Galloping Hill Road
City
Kenilworth
State
New Jersey
Zip Code
07033
Country
United States
Website
https://merckoncologyclinicaltrials.com/en-us/patient/liver-and-bile-duct
Study Contacts
Principal Investigator
Merck Sharp & Dohme Corp.
P.I. Phone
(188) 857-7883
P.I. Email
Trialsites@merck.com
List additional Principal Investigators (include phone number and email)
Please refer to study locations listed Clinicaltrial.gov, as locations will be added throughout the study.
Study Coordinator
TBD
Study Coordinator Phone
(188) 857-7883
Study Coordinator Email
Trialsites@merck.com
OVERVIEW – in layman’s terms (150 words max)
This is a study of pembrolizumab plus gemcitabine/cisplatin vs. placebo plus gemcitabine/cisplatin as first-line therapy in people with advanced and/or unresectable BTC.
Enrollment
788
Study Start Date
09/30/2019
Estimated Completion Date
01/11/2022
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
  • To compare progression-free survival between pembrolizumab plus gemcitabine/cisplatin and placebo plus gemcitabine/cisplatin
  • To compare overall survival between pembrolizumab plus gemcitabine/cisplatin and placebo plus gemcitabine/cisplatin
Inclusion Criteria – Patients Must:
  • Has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer).
  • Have 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.
  • Provide archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion.
  • Have a life expectancy of greater than 3 months.
  • Have adequate organ function.
Exclusion Criteria – Patients Must NOT:
  • 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 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., 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.
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