2023-506657-38-00已完成3 期
A Phase 3 Randomized, Double Blind 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
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 27
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
To compare overall survival (OS) between pembrolizumab plus gemcitabine/cisplatin and placebo plus gemcitabine/cisplatin
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
KEYTRUDA 25 mg/mL concentrate for solution for infusion
Test
干预措施: KEYTRUDA 25 mg/mL concentrate for solution for infusion (Drug)
CISPLATIN
Comparator
干预措施: CISPLATIN (Drug)
GEMCITABINE
Comparator
干预措施: GEMCITABINE (Drug)
Placebo to MK-3475
Placebo
干预措施: Placebo to MK-3475 (Drug)
结局指标
主要结局
Overall Survival (OS)
Overall Survival (OS)
次要结局
- Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)
- Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR
- Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
- Number of Participants Who Experienced One or More Adverse Events (AEs)
- Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)
研究者
Usha Malhotra
Scientific
Merck Sharp & Dohme LLC
研究点 (27)
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