Study Name |
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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) |
ClinicalTrials.gov Identifier (if applicable) |
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NCT04003636 |
Clinical Trial Category (check all that apply) |
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- First Line Therapy
- Chemotherapy
- Immunotherapy
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Study Center |
Institution Name |
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Merck Sharp & Dohme Corp. |
Institution Address |
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2000 Galloping Hill Road |
City |
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Kenilworth |
State |
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New Jersey |
Zip Code |
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07033 |
Country |
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United States |
Website |
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https://merckoncologyclinicaltrials.com/en-us/patient/liver-and-bile-duct |
Study Contacts |
Principal Investigator |
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Merck Sharp & Dohme Corp. |
P.I. Phone |
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(188) 857-7883 |
P.I. Email |
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Trialsites@merck.com |
List additional Principal Investigators (include phone number and email) |
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Please refer to study locations listed Clinicaltrial.gov, as locations will be added throughout the study. |
Study Coordinator |
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TBD |
Study Coordinator Phone |
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(188) 857-7883 |
Study Coordinator Email |
|
Trialsites@merck.com |
OVERVIEW – in layman’s terms (150 words max) |
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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 |
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788 |
Study Start Date |
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09/30/2019 |
Estimated Completion Date |
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01/11/2022 |
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items) |
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- 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
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Inclusion Criteria – Patients Must: |
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- 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.
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Exclusion Criteria – Patients Must NOT: |
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- 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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