A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma [IMbrave150]

Description

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.

Study Start Date

March, 31 2018

Estimated Completion Date

June 2022

Interventions

  • Drug: Atezolizumab
  • Drug: Bevacizumab
  • Drug: Sorafenib

Study ID

Hoffmann-La Roche -- YO40245

Status

Recruiting

Trial ID

NCT03434379

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

480

Sponsor

Hoffmann-La Roche

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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)

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (23)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
Yale Cancer Center - New Haven, Connecticut 119.2 miles None None None
Stony Brook University Hospital - Stony Brook, New York 145.7 miles None None None
Laura and ISAAC Perlmutter Cancer Center at NYU Langone - New York, New York 186.5 miles None None None
Thomas Jefferson University - Philadelphia, Pennsylvania 269.5 miles None None None
Georgetown University - Washington, District of Columbia 394.4 miles None None None
Henry Ford Health System - Detroit, Michigan 612.3 miles None None None
University of Chicago - Chicago, Illinois 848.0 miles None None None
SCRI - Nashville, Tennessee 942.8 miles None None None
Washington University - Saint Louis, Missouri 1,039.5 miles None None None
Fairview Clinical Trials Services - Minneapolis, Minnesota 1,119.5 miles None None None
Moffitt Cancer Center - Tampa, Florida 1,172.3 miles None None None
MD Anderson Cancer Center Uni of Texas At Houston - Houston, Texas 1,609.9 miles None None None
University of Arizona Cancer Center - Tucson, Arizona 2,281.2 miles None None None
The University of Arizona Cancer Center at Dignity Health St Josephs Hospital and Medical Center - Phoenix, Arizona 2,284.4 miles None None None
Banner MD Anderson Cancer Center - Gilbert, Arizona 2,285.1 miles None None None
Swedish Cancer Inst - Seattle, Washington 2,489.6 miles None None None
City of Hope - Duarte, California 2,578.2 miles None None None
Uni of California San Diego Cancer Center Dept of Medicine - La Jolla, California 2,581.5 miles None None None
University of California Irvine Medical Center - Orange, California 2,585.0 miles None None None
University of California Los Angeles - Santa Monica, California 2,607.9 miles None None None
Kaiser Permanente Northern California - Novato, California 2,678.4 miles None None None
California Pacific Medical Center - San Francisco, California 2,698.0 miles None None None

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