jRCT2080224605已完成2 期
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. Japan1 个研究点目标入组 141 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 141
- 试验地点
- 1
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Nonrandomized, Single Group Assignment, Open Label
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 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
研究点 (1)
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