Overview

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)

Status:
Active, not recruiting
Trial end date:
2023-08-31
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Treatments:
Cisplatin
Gemcitabine
Pembrolizumab
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