A Study of Safety, Tolerability, and Clinical Activity of Durvalumab and Tremelimumab Administered as Monotherapy, or Durvalumab in Combination with Tremelimumab or Bevacizumab in Subjects with Advanced Hepatocellular Carcinoma - NA

MEDIMMUNE, LLC0 个研究点目标入组 456 人开始时间: 2021年1月22日最近更新: 2024年1月8日

适应症

试验速览

暂无简介。

•1. Male or female subjects
•2. 18 years and older
•3. Confirmed HCC based on histopathological findings from tumor tissues. Advanced HCC with diagnosis confirmed pathologically or with noninvasive methods.
•4. Immunotherapy-naive and have either progressed on, are intolerant to, or refused treatment with sorafenib or another approved VEGFR TKI. Part 4 only: Must not have received prior systemic therapy for HCC.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 292
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 164

•1. Prior exposure to immune-mediated therapy
•2. Hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy.
•3. GI Bleeding (eg, esophageal varices or ulcer bleeding) within 12 months.
•4. Ascites requiring nonpharmacologic intervention to maintain symptom control, within 6 months prior to the first scheduled dose.
•5. Main portal vein thrombosis (Vp4) as documented on imaging
•6. Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment
•7. Active or prior documented autoimmune or inflammatory disease with some exceptions
•8. Current or prior use of immunosuppressive medication within 14 days of first dose of IP, with some exceptions

发起方