Summary

for people ages 18-99 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Robin Kate Kelley

Description

Summary

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

Official Title

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

Keywords

Hepatocellular Carcinoma Immunotherapy Antibodies, Monoclonal Tremelimumab MEDI4736 Durvalumab Carcinoma Carcinoma, Hepatocellular MEDI4736 + tremelimumab MEDI4736 & Tremelimumab MEDI4736 & Tremelimumab.

Eligibility

You can join if…

Open to people ages 18-99

  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.

You CAN'T join if...

  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

Locations

  • Research Site accepting new patients
    San Francisco California 94158 United States
  • Research Site accepting new patients
    Scottsdale Arizona 85054 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
MedImmune LLC
ID
NCT02519348
Phase
Phase 2
Lead Scientist
Robin Kate Kelley
Study Type
Interventional
Last Updated