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)-China Extension Study
Biliary Tract Carcinoma
About this trial
This is an interventional treatment trial for Biliary Tract Carcinoma focused on measuring Programmed cell death 1 (PD-1), Pembrolizumab, Cholangiocarcinoma, Gallbladder cancer, Checkpoint inhibitor, Immunotherapy, Biliary, Keytruda, Bile Duct Cancer
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
Sites / Locations
- Anhui Provincial Hospital ( Site 0140)
- Beijing Cancer Hospital ( Site 0138)
- Peking Union Medical College Hospital ( Site 0150)
- First Affiliated Hospital of The Third Military Medical University ( Site 0130)
- Fujian Provincial Cancer Hospital ( Site 0154)
- 900 Hospital of the Joint ( Site 0137)
- Guangdong Provincial People s Hospital ( Site 0161)
- Harbin Medical University Cancer Hospital ( Site 0133)
- Hunan Provincial People Hospital ( Site 0142)
- Hunan Cancer Hospital ( Site 0132)
- The Third Xiangya Hospital of Central South University ( Site 0157)
- The 81st Hospital of PLA ( Site 0128)
- The First Hospital of Jilin University ( Site 0131)
- Zhongshan Hospital Fudan University ( Site 0129)
- Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0158)
- Fudan University Shanghai Cancer Center ( Site 0160)
- Tangdu Hospital ( Site 0146)
- The First Affiliated Hospital of Xi an Jiaotong University ( Site 0145)
- West China Hospital of Sichuan University ( Site 0147)
- Tianjin Medical University Cancer Institute & Hospital ( Site 0155)
- The First Affiliated Hospital Zhejiang University ( Site 0136)
- Zhejiang Cancer Hospital ( Site 0134)
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Arm A (Pembrolizumab+Gemcitabine+Cisplatin)
Arm B (Placebo+Gemcitabine+Cisplatin)
Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles.
Placebo to Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles.