A Phase II, Open-label, Multi-cohort, Multicenter Study in Patients With Unresectable Hepatocellular Carcinoma and Child-pugh B7 and B8 Cirrhosis
Summary
The purpose of this study is to assess the safety of atezolizumab and bevacizumab, or atezolizumab alone, as first-line treatment in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC) with Child-pugh B7 or B8 cirrhosis.
Detailed description
This is a Phase II, open-label, multicohort, multicenter study in participants with unresectable, locally advanced, or metastatic HCC who have Child-pugh B7 or B8 liver cirrhosis and have received no prior systemic therapy in this treatment setting. The study is designed to non-comparatively evaluate the safety of atezolizumab plus bevacizumab (Cohort A) or atezolizumab monotherapy (Cohort B) in this population.
Arms & interventions
- DrugAtezolizumab
Atezolizumab will be administered at a dose of 1200 milligrams (mg) by intravenous (IV) infusion on Day 1 of each 21-day cycle.
- DrugBevacizumab
Bevacizumab will be administered at a dose of 15 milligrams per kilogram (mg/kg) by IV infusion on Day 1 of each 21-day cycle.
Outcome measures
Primary
Percentage of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant or clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Severity is determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) in Cohorts A and B.
Time frame: Baseline through the end of the study (up to approximately 36 months)
Eligibility criteria
Study locations (60)
University of Arizona Cancer Center
Tucson, Arizona, 85724
UC San Diego Moores Cancer Center
La Jolla, California, 92093
University of Southern California-Keck School of Medicine -1975 Zonal Ave
Los Angeles, California, 90089-5601
University of Southern California
Newport Beach, California, 92663
University of California Irvine Medical Center
Orange, California, 92868
California Liver Research Institute
Pasadena, California, 91105-2561
University of California Davis Medical Center
Sacramento, California, 95817
Stanford Health Care
Stanford, California, 94305
Harbor UCLA Medical Center
Torrance, California, 90502-2006
Cedars Sinai Comprehensive Transplant Center
West Hollywood, California, 90048-2422
Rocky Mountain Cancer Centers (Williams) - USOR
Denver, Colorado, 80218-1237
Hartford Healthcare Cancer Institute at Hartford Hospital
Hartford, Connecticut, 06106
Washington DC VA Medical Center
Washington D.C., District of Columbia, 20422-0001
Orlando Health Inc.
Orlando, Florida, 32806
Northwestern University
Chicago, Illinois, 60611-2908
University of Illinois Health Outpatient Care Center
Chicago, Illinois, 60612-4795
The Duchossois Center for Advanced Medicine
Chicago, Illinois, 60637-1426
University of Kentucky - Markey Cancer Center
Lexington, Kentucky, 40536-7001
LSU Health Baton Rouge
Baton Rouge, Louisiana, 70805
Our Lady of the Lake Cancer Institute
Baton Rouge, Louisiana, 70808-4300
Tufts Medical Center
Boston, Massachusetts, 02111
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Veterans Affairs Ann Arbor Healthcare System
Ann Arbor, Michigan, 48105
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Henry Ford Health System
Detroit, Michigan, 48202
Saint Luke?s Hospital of Kansas City
Kansas City, Missouri, 64111
MorristownMedicalCenter
Morristown, New Jersey, 07962
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Rutgers Cancer Institute of New Jersey at University Hospital
Newark, New Jersey, 07103
NYU Langone Hospital - Long Island
Mineola, New York, 11501-4064
R.J. Zuckerberg Cancer Hospital/Northwell Health - BRANY - PPDS
New Hyde Park, New York, 11042-1118
NYU Langone Medical Center
New York, New York, 10016-9451
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Montefiore Medical Center
The Bronx, New York, 10467
James J Peters Veterans Administration Medical Center - NAVREF
The Bronx, New York, 10468-3904
Levine Cancer Institute
Charlotte, North Carolina, 28204
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Dayton VA Medical Center - NAVREF - PPDS
Dayton, Ohio, 45428-9000
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104-5020
Kaiser Permanente Westside Medical Center
Hillsboro, Oregon, 97124-5806
OHSU Knight Cancer Institute Hematology Oncology
Portland, Oregon, 97239-3011
Jefferson Health Honickman Center
Philadelphia, Pennsylvania, 19107
Veterans Affairs Pittsburgh Healthcare System - NAVREF - PPDS
Pittsburgh, Pennsylvania, 15240
The West Clinic (East Campus)
Germantown, Tennessee, 38138-1762
Nashville General Hospital at Meharry
Nashville, Tennessee, 37208-2918
Liver Institute at Methodist Dallas
Dallas, Texas, 75203-1260
Moody Outpatient Center ? Parkland Health
Dallas, Texas, 75235
Texas Oncology (Worth) - USOR
Dallas, Texas, 75246-2008
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-0001
Texas Oncology - Denison Cancer Center
Denison, Texas, 75020-0084
Kelsey Research Foundation
Houston, Texas, 77025-1669
Michael E Debakey VA Medical Center - NAVREF - PPDS
Houston, Texas, 77030-4211
Houston Methodist Hospital
Houston, Texas, 77030
Intermountain Healthcare
Murray, Utah, 84107-5741
Intermountain Cancer Center
St. George, Utah, 84790
Inova Schar Cancer Institute
Falls Church, Virginia, 22042
Maryview Hospital, Inc.
Newport News, Virginia, 23602
Bon Secours St. Mary's Hospital
Richmond, Virginia, 23226-1925
VCU Medical Center North Hospital
Richmond, Virginia, 23298-5028
Virginia Mason Medical Center
Seattle, Washington, 98101