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



Status:Recruiting
Conditions:Liver Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/29/2019
Start Date:March 15, 2018
End Date:June 29, 2022
Contact:Reference Study ID Number: YO40245 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

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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

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.

The participants will be randomized in a 2:1 ratio to one of the two treatment arms: Arm A
(experimental arm): Atezolizumab +bevacizumab; Arm B (control arm): Sorafenib

Inclusion Criteria:

- Locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC)

- No prior systemic therapy for HCC. Previous use of herbal therapies/traditional
Chinese medicines with anti-cancer activity included in the label is allowed, provided
that these medications are discontinued prior to randomization.

- 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

- Known 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

- Untreated or incompletely treated esophageal and/or gastric varices with bleeding or
high-risk for bleeding

- A prior bleeding event due to esophageal and/or gastric varices within 6 months prior
to initiation of study treatment.

- 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

- Local therapy to liver within 28 days prior to initiation of study treatment or
non-recovery from side effects of any such procedure

- Chronic daily treatment with a non-steroidal anti-inflammatory drug (NSAID)
We found this trial at
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101 The City Drive South
Orange, California 92868
714-456-7890
University of California, Irvine Medical Center We are UC Irvine Health. We are a devoted...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Bankstown, New South Wales 2200
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Detroit, Michigan 48202
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Duarte, California 91010
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Gilbert, Arizona 85234
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1515 Holcombe Boulevard
Houston, Texas 77030
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9500 Gilman Drive
La Jolla, California 92093
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Minneapolis, Minnesota 55414
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Nashville, Tennessee 37203
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333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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New York, New York 10016
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1761 Broadway Street
Novato, California 94589
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Oakland, California 94611
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Roseville, California 95678
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Sacramento, California 95825
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660 South Euclid Avenue
Saint Louis, Missouri 63110
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45 Castro Street
San Francisco, California 94114
(415) 600-6000
California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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San Francisco, California 94115
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405 Hilgard Avenue
Santa Monica, California 90404
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Seattle, Washington 98104
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3700 O St NW
Washington, District of Columbia 20057
(202) 687-0100
Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
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