| 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.
|
