A Phase II, Multicenter, Open-label Study to Investigate the Clinical Efficacy of M7824 Monotherapy in Participants With Locally Advanced or Metastatic Biliary Tract Cancer Who Fail or Are Intolerant to First-line Platinum-Based Chemotherapy

Merck Biopharma Co., Ltd. Japan0 个研究点目标入组 141 人开始时间: 2019年3月20日最近更新: 2023年10月17日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 141

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 18age old 至 ot applicable（—）
性别: All

入选标准

•participants with histologically or cytologically confirmed locally advanced or metastatic BTC.
•- Availability of tumor (primary or metastatic) archival material or fresh biopsies (collected within 28 days before first administration) of study intervention is mandatory
•- Participants with BTC must have failed or be intolerant to 1L systemic platinum-based chemotherapy
•- Disease must be measurable with at least 1 unidimensionally measurable lesion by RECIST 1.1
•- Eastern Cooperative Oncology Group (ECOG) PS of 0 to 1
•- Life expectancy more than 12 weeks as judged by the Investigator
•- Adequate hematological function defined by white blood cell (WBC) count more than 3 X 10^9/L with absolute neutrophil count (ANC) more than 1.5 X 10^9/L, lymphocyte count more than 0.5 X 10^9/L, platelet count more than 75 X 10^9/L, and hemoglobin (Hgb) more than 9 g/dL
•- Adequate hepatic function defined by a total bilirubin level less than 1.5 X upper limit of normal (ULN), an aspartate aminotransferase (AST) level less than 2.5 X ULN, and an alanine aminotransferase (ALT) level less than 2.5 X ULN. For participants with liver involvement in their tumor, AST less than 5.0 X ULN and ALT less than 5.0 X ULN is acceptable
•- Adequate coagulation function defined as prothrombin time (PT) or international normalized ratio (INR) less than 1.5 X ULN unless the participant is receiving anticoagulant therapy
•- Albumin more than 3.0 g/dL
•- Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive participants must be treated and on a stable dose of antivirals
•- dequate renal function defined by either creatinine more than 1.5 X ULN or an estimated creatinine clearance (CCr) > 40 mL per min according to the Cockcroft-Gault formula or by measure of CCr from 24-hour urine collection
•- Other protocol defined inclusion criteria could apply

排除标准

•- Ampullary cancer is excluded
•- Significant acute or chronic infections
•- Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
•- Interstitial lung disease or its history
•- Participants who are not eligible for or have not been treated with 1L systemic chemotherapy
•- Anticancer treatment within 21 days before the start of study intervention
•- Concurrent treatment with nonpermitted drugs
•- Prior participation in a M7824 clinical trial
•- Prior therapy with other immunotherapy or checkpoint inhibitors, such as anti-PD 1, anti PD L1, anti-cytotoxic T-cell lymphocyte-4 (CTLA-4) antibodies.
•- Pregnancy or breast feeding
•- Other protocol defined exclusion criteria could apply

研究者

发起方

Merck Biopharma Co., Ltd. Japan

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