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 durvalumab or tremelimumab monotherapy, or durvalumab in combination with tremelimumab or bevacizumab in advanced hepatocellular carcinoma.

Official Title

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

Keywords

Hepatocellular CarcinomaImmunotherapyAntibodies, MonoclonalTremelimumabMEDI4736DurvalumabCarcinomaCarcinoma, HepatocellularBevacizumabDurvalumab + tremelimumabDurvalumab + BevacizumabDurvalumab & Bevacizumab

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. Advanced HCC with diagnosis confirmed pathologically or with noninvasive methods.
  4. Immunotherapy-naïve
  5. Have either progressed on, are intolerant to, or refused treatment with sorafenib or another approved TKI. For arm 5 only: Have not received any prior systemic therapy for HCC.

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 (eg, paracentesis) to maintain symptomatic 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 FranciscoCalifornia94158United States
  • Research Site accepting new patients
    ScottsdaleArizona85054United States

Lead Scientist

Details

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