A Study of Safety, Tolerability, and Clinical Activity of MEDI4736 and Tremelimumab Administered as Monotherapy and in Combination to Subjects with Unresectable Hepatocellular Carcinoma

This is a multicenter, open-label, stratified, randomized study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of MEDI4736 in combination with tremelimumab, MEDI4736 monotherapy or tremelimumab monotherapy in subjects with unresectable hepatocellular carcinoma.

Inclusion Criteria:
• Confirmed diagnosis of unresectable hepatocellular carcinoma with or without concomitant viral hepatits B or hepatitis C infection.
• Subjects must have either: progressed on, are intolerant to, or refused treatment with sorafenib.

Exclusion Criteria:
• Prior exposure to immune-mediated therapy
Phase II
Todd Crocenzi, M.D.
MedImmune, LLC
Mary Mccormick
  • Providence Cancer Institute Franz Clinic