Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

This study will evaluate the efficacy and safety of atezolizumab in combination with bevacizumab compared with sorafenib in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have received no prior systemic treatment.

Official Title

A Phase III, Open-Label, Randomized Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma

Keywords

Carcinoma, Hepatocellular Carcinoma Bevacizumab Sorafenib Atezolizumab Niacinamide Antibodies, Monoclonal Atezolizumab + Bevacizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • Locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC)
  • No prior systemic therapy for HCC
  • At least one measurable untreated lesion
  • ECOG Performance Status of 0 or 1
  • Adequate hematologic and end-organ function
  • For women of childbearing potential: agreement to remain abstinent
  • For men: agreement to remain abstinent
  • Child-Pugh class A

You CAN'T join if...

  • History of leptomeningeal disease
  • Active or history of autoimmune disease or immune deficiency
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan
  • Active tuberculosis
  • History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
  • Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within at least 5 months after the last dose of atezolizumab, 6 months after the last dose of bevacizumab, or 1 month after the last dose of sorafenib
  • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
  • Patients with untreated or incompletely treated varices with bleeding or high-risk for bleeding
  • Moderate or severe ascites
  • History of hepatic encephalopathy
  • Co-infection of HBV and HCV
  • Symptomatic, untreated, or actively progressing central nervous system (CNS)metastases
  • Uncontrolled tumor-related pain
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
  • Uncontrolled or symptomatic hypercalcemia
  • Treatment with systemic immunostimulatory agents
  • Inadequately controlled arterial hypertension
  • Prior history of hypertensive crisis or hypertensive encephalopathy
  • Evidence of bleeding diathesis or significant coagulopathy
  • History of intestinal obstruction and/or clinical signs or symptoms of GI obstruction including sub-occlusive disease related to the underlying disease or requirement for routine parenteral hydration
  • Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture
  • Metastatic disease that involves major airways or blood vessels, or centrally located mediastinal tumor masses
  • Chronic daily treatment with a non-steroidal anti-inflammatory drug (NSAID)

Locations

  • Uni of California - San Diego; Cancer Center & Dept of Medicine accepting new patients
    La Jolla California 92093 United States
  • University of California Irvine Medical Center in progress, not accepting new patients
    Orange California 92868 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT03434379
Phase
Phase 3
Study Type
Interventional
Last Updated
October 1, 2018