Last updated on March 2019

A Study of MEDI4736 With Tremelimumab MEDI4736 or Tremelimumab Monotherapy in Unresectable Hepatocellular Carcinoma

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Age: Between 18 - 99 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Male or female subjects
  2. 18 years and older (Japan-20 years and older)
  3. Confirmed HCC based on histopathological findings from tumor tissues. Unresectable 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. Subjects who receive treatment with systemic therapies other than sorafenib are not eligible.

Exclusion Criteria:

  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 non-pharmacologic intervention or escalation in pharmacologic 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 with some exceptions

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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