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
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 | |
---|---|---|---|---|
Yale Cancer Center - New Haven, Connecticut | 18.1 miles | None | None | None |
Stony Brook University Hospital - Stony Brook, New York | 22.8 miles | None | None | None |
Laura and ISAAC Perlmutter Cancer Center at NYU Langone - New York, New York | 50.2 miles | None | None | None |
Thomas Jefferson University - Philadelphia, Pennsylvania | 133.3 miles | None | None | None |
Massachusetts General Hospital - Boston, Massachusetts | 137.9 miles | None | None | None |
Georgetown University - Washington, District of Columbia | 258.0 miles | None | None | None |
Henry Ford Health System - Detroit, Michigan | 513.4 miles | None | None | None |
University of Chicago - Chicago, Illinois | 744.7 miles | None | None | None |
SCRI - Nashville, Tennessee | 810.5 miles | None | None | None |
Washington University - Saint Louis, Missouri | 919.8 miles | None | None | None |
Fairview Clinical Trials Services - Minneapolis, Minnesota | 1,040.5 miles | None | None | None |
Moffitt Cancer Center - Tampa, Florida | 1,044.1 miles | None | None | None |
MD Anderson Cancer Center Uni of Texas At Houston - Houston, Texas | 1,475.7 miles | None | None | None |
University of Arizona Cancer Center - Tucson, Arizona | 2,164.4 miles | None | None | None |
The University of Arizona Cancer Center at Dignity Health St Josephs Hospital and Medical Center - Phoenix, Arizona | 2,171.4 miles | None | None | None |
Banner MD Anderson Cancer Center - Gilbert, Arizona | 2,171.5 miles | None | None | None |
Swedish Cancer Inst - Seattle, Washington | 2,426.6 miles | None | None | None |
Uni of California San Diego Cancer Center Dept of Medicine - La Jolla, California | 2,471.8 miles | None | None | None |
City of Hope - Duarte, California | 2,472.0 miles | None | None | None |
University of California Irvine Medical Center - Orange, California | 2,477.9 miles | None | None | None |
University of California Los Angeles - Santa Monica, California | 2,501.9 miles | None | None | None |
Kaiser Permanente Northern California - Novato, California | 2,585.9 miles | None | None | None |
California Pacific Medical Center - San Francisco, California | 2,604.7 miles | None | None | None |