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Eligibility
for people ages 18 years to 99 years
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator
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

Eligibility

You can join if…

Open to people ages 18 years to 99 years

  1. Male or female subjects
  2. 18 years and older (Japan-20 years and older)
  3. Confirmed diagnosis of unresectable hepatocellular carcinoma with or without concomitant viral hepatits B or hepatitis C infection.
  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 characterized by asterixis
  3. Active or prior documented gastrointestinal variceal bleed
  4. Ascites requiring non-pharmacologic intervention or escalation in pharmacologic intervention to maintain symptom control
  5. Main portal vein thrombosis
  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, USA
  • Research Site accepting new patients
    Scottsdale, Arizona, USA
  • Research Site accepting new patients
    New Haven, Connecticut, USA
  • Research Site accepting new patients
    Jacksonville, Florida, USA
  • Research Site accepting new patients
    Tampa, Florida, USA
  • Research Site accepting new patients
    Indianapolis, Indiana, USA
  • Research Site accepting new patients
    Boston, Massachusetts, USA
  • Research Site accepting new patients
    New York, New York, USA
  • Research Site accepting new patients
    Durham, North Carolina, USA
  • Research Site accepting new patients
    Portland, Oregon, USA
  • Research Site accepting new patients
    Philadelphia, Pennsylvania, USA
  • Research Site accepting new patients
    Nashville, Tennessee, USA
  • Research Site accepting new patients
    Dallas, Texas, USA
  • Research Site accepting new patients
    Seattle, Washington, USA
  • Research Site accepting new patients
    Pok Fum Lam, Hong Kong
  • Research Site accepting new patients
    Shatin, Hong Kong
  • Research Site accepting new patients
    Benevento, Italy
  • Research Site accepting new patients
    Napoli, Italy
  • Research Site not yet accepting patients
    Roma, Italy
  • Research Site accepting new patients
    Chuo-ku, Japan
  • Research Site accepting new patients
    Kashiwa-shi, Japan
  • Research Site accepting new patients
    Osakasayama-shi, Japan
  • Research Site accepting new patients
    Seoul, Korea, Republic of
  • Research Site accepting new patients
    Songpa-gu, Korea, Republic of
  • Research Site accepting new patients
    Bukit Merah, Singapore
  • Research Site accepting new patients
    Singapore, Singapore
  • Research Site accepting new patients
    Barcelona, Spain
  • Research Site accepting new patients
    Cordoba, Spain
  • Research Site accepting new patients
    Navarra, Spain
  • Research Site accepting new patients
    Kaohsiung City, Taiwan
  • Research Site accepting new patients
    Taipei, Taiwan
  • Research Site accepting new patients
    Taoyuan City, Taiwan

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
February 2017
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