Phase
Condition
Liver Disease
Liver Cancer
Liver Disorders
Treatment
Bevacizumab
Atezolizumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
General Inclusion Criteria:
Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed byhistology/cytology or clinically by American Association for the Study of LiverDiseases (AASLD) criteria in cirrhotic participants
Disease that is not amenable to curative surgical and/or locoregional therapies
No prior systemic treatment (including systemic investigational agents) for locallyadvanced or metastatic and/or unresectable HCC
Measurable disease (at least one untreated target lesion) according to RECIST v1.1
ECOG Performance Status of 0-2 within 7 days prior to initiation of study treatment
Child-Pugh B7 or B8 cirrhosis at screening and within 7 days prior to studytreatment
Adequate hematologic and end-organ function
Life expectancy of at least 12 weeks
Female participants of childbearing potential must be willing to avoid pregnancy andegg donation
Absolute neutrophil count ≥1.0 x 109/L (≥1000/μL) without granulocytecolony-stimulating factor support
Platelet count ≥ 50 × 109/L (50,000/μL) without transfusion
Hemoglobin ≥ 80 g/L (8 g/dL) AST and ALT ≤ 5 × upper limit of normal (ULN)
Serum bilirubin ≤ 3 × ULN
Creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula)
Serum albumin ≥ 20 g/L (2.0 g/dL) without transfusion in the prior 3 months
INR ≤2.3
Exclusion
General Exclusion Criteria:
Pregnancy or breastfeeding
Prior treatment with CD137 agonists or immune checkpoint blockade therapies
Treatment with investigational therapy within 28 days prior to initiation of studytreatment
Treatment with locoregional therapy to liver within 28 days prior to initiation ofstudy treatment, or non-recovery from side effects of any such procedure
Treatment with systemic immunostimulatory agents
Treatment with systemic immunosuppressive medication
Treatment with a live, attenuated vaccine within 4 weeks prior to initiation ofstudy treatment
Inadequately controlled hypertension
Active or history of autoimmune disease or immune deficiency
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-inducedpneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis onscreening chest computed tomography (CT) scan
Participants who have a known concurrent malignancy that is progressing or requiresactive treatment, who have not completely recovered from treatment, or who have asignificant malignancy history that, in the opinion of the investigator, shouldpreclude participation.
Participants on preventative hormonal therapies (i.e., tamoxifen and other hormonalinhibitors) are not excluded.
Known fibrolamellar HCC, sarcomatoid HCC, other rare HCC variant, or mixedcholangiocarcinoma and HCC
Symptomatic, untreated, or actively progressing central nervous system (CNS)metastases
Prior allogeneic stem cell or solid organ transplantation
Actively listed for liver transplantation
Co-infection with hepatitis B virus (HBV) and hepatitis C virus (HCV)
Untreated or incompletely treated esophageal and/or gastric varices with bleeding orthat are at high risk for bleeding
A prior bleeding event due to esophageal and/or gastric varices within 6 monthsprior to initiation of study treatment
Grade ≥3 hemorrhage or bleeding event within 6 months prior to initiation of studytreatment
Hepatic encephalopathy is allowed if no active symptoms or stable within 3 months ofstudy treatment
History, planned, or recommended placement of transjugular intrahepaticportosystemic shunt (TIPS) is excluded from Cohort A only. TIPS is acceptable inCohort B.
Diagnostic Paracentesis is allowed. Therapeutic Paracentesis within 3 months is anexclusion criteria
Participants with ascites controlled on diuretics are allowed.
History of spontaneous bacterial peritonitis within last 12 months
Study Design
Study Description
Connect with a study center
Pan American Center for Oncology Trials, LLC
Rio Piedras, 00935
Puerto RicoSite Not Available
Pan American Center for Oncology Trials, LLC
Rio Piedras 4829037, 00935
Puerto RicoActive - Recruiting
University of Arizona Cancer Center
Tucson, Arizona 85724
United StatesSite Not Available
University of Arizona Cancer Center
Tucson 5318313, Arizona 5551752 85724
United StatesActive - Recruiting
UC San Diego Moores Cancer Center
La Jolla, California 92093
United StatesSite Not Available
University of Southern California-Keck School of Medicine -1975 Zonal Ave
Los Angeles, California 90089-5601
United StatesSite Not Available
University of Southern California
Newport Beach, California 92663
United StatesSite Not Available
University of Southern California; Oncology/Hematology
Newport Beach, California 92663
United StatesActive - Recruiting
University of California Irvine Medical Center
Orange, California 92868
United StatesSite Not Available
California Liver Research Institute
Pasadena, California 91105-2561
United StatesSite Not Available
University of California Davis Medical Center
Sacramento, California 95817
United StatesSite Not Available
Stanford Health Care
Stanford, California 94305
United StatesSite Not Available
Harbor UCLA Medical Center
Torrance, California 90502-2006
United StatesSite Not Available
Cedars Sinai Comprehensive Transplant Center
West Hollywood, California 90048-2422
United StatesSite Not Available
UC San Diego Moores Cancer Center
La Jolla 5363943, California 5332921 92093
United StatesActive - Recruiting
University of Southern California-Keck School of Medicine -1975 Zonal Ave
Los Angeles 5368361, California 5332921 90089-5601
United StatesActive - Recruiting
University of Southern California
Newport Beach 5376890, California 5332921 92663
United StatesActive - Recruiting
University of California Irvine Medical Center
Orange 5379513, California 5332921 92868
United StatesCompleted
California Liver Research Institute
Pasadena 5381396, California 5332921 91105-2561
United StatesActive - Recruiting
University of California Davis Medical Center
Sacramento 5389489, California 5332921 95817
United StatesActive - Recruiting
Stanford Health Care
Stanford 5398563, California 5332921 94305
United StatesActive - Recruiting
Harbor UCLA Medical Center
Torrance 5403022, California 5332921 90502-2006
United StatesActive - Recruiting
Cedars Sinai Comprehensive Transplant Center
West Hollywood 5408076, California 5332921 90048-2422
United StatesActive - Recruiting
Rocky Mountain Cancer Centers (Williams) - USOR
Denver, Colorado 80218-1237
United StatesSite Not Available
Rocky Mountain Cancer Centers (Williams) - USOR
Denver 5419384, Colorado 5417618 80218-1237
United StatesActive - Recruiting
Hartford Healthcare Cancer Institute at Hartford Hospital
Hartford, Connecticut 06106
United StatesSite Not Available
Hartford Healthcare Cancer Institute at Hartford Hospital
Hartford 4835797, Connecticut 4831725 06106
United StatesActive - Recruiting
Washington DC VA Medical Center
Washington, District of Columbia 20422-0001
United StatesSite Not Available
Washington DC VA Medical Center
Washington D.C. 4140963, District of Columbia 4138106 20422-0001
United StatesActive - Recruiting
Orlando Health Inc.
Orlando, Florida 32806
United StatesSite Not Available
Orlando Health Inc.
Orlando 4167147, Florida 4155751 32806
United StatesActive - Recruiting
Northwestern University
Chicago, Illinois 60611-2908
United StatesActive - Recruiting
The Duchossois Center for Advanced Medicine
Chicago, Illinois 60637-1426
United StatesSite Not Available
University of Illinois Health Outpatient Care Center
Chicago, Illinois 60612-4795
United StatesActive - Recruiting
Northwestern University
Chicago 4887398, Illinois 4896861 60611-2908
United StatesActive - Recruiting
The Duchossois Center for Advanced Medicine
Chicago 4887398, Illinois 4896861 60637-1426
United StatesActive - Recruiting
University of Illinois Health Outpatient Care Center
Chicago 4887398, Illinois 4896861 60612-4795
United StatesActive - Recruiting
University of Kentucky - Markey Cancer Center
Lexington, Kentucky 40536-7001
United StatesSite Not Available
University of Kentucky - Markey Cancer Center
Lexington 4297983, Kentucky 6254925 40536-7001
United StatesActive - Recruiting
LSU Health Baton Rouge
Baton Rouge, Louisiana 70805
United StatesSite Not Available
LSU Health Baton Rouge; North Clinic
Baton Rouge, Louisiana 70805
United StatesActive - Recruiting
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana 70808-4375
United StatesActive - Recruiting
LSU Health Baton Rouge
Baton Rouge 4315588, Louisiana 4331987 70805
United StatesActive - Recruiting
Our Lady of the Lake Physician Group
Baton Rouge 4315588, Louisiana 4331987 70808-4375
United StatesActive - Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesSite Not Available
Tufts Medical Center
Boston, Massachusetts 02111
United StatesActive - Recruiting
Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926 02215
United StatesActive - Recruiting
Tufts Medical Center
Boston 4930956, Massachusetts 6254926 02111
United StatesActive - Recruiting
Veterans Affairs Ann Arbor Healthcare System
Ann Arbor, Michigan 48105
United StatesSite Not Available
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesSite Not Available
Henry Ford Health System
Detroit, Michigan 48202
United StatesActive - Recruiting
Veterans Affairs Ann Arbor Healthcare System
Ann Arbor 4984247, Michigan 5001836 48105
United StatesActive - Recruiting
Barbara Ann Karmanos Cancer Institute
Detroit 4990729, Michigan 5001836 48201
United StatesActive - Recruiting
Henry Ford Health System
Detroit 4990729, Michigan 5001836 48202
United StatesActive - Recruiting
Saint Luke?s Hospital of Kansas City
Kansas City, Missouri 64111
United StatesSite Not Available
Saint Luke?s Hospital of Kansas City
Kansas City 4393217, Missouri 4398678 64111
United StatesActive - Recruiting
MorristownMedicalCenter
Morristown, New Jersey 07962
United StatesSite Not Available
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901
United StatesSite Not Available
Rutgers Cancer Institute of New Jersey at University Hospital
Newark, New Jersey 07103
United StatesSite Not Available
MorristownMedicalCenter
Morristown 5101427, New Jersey 5101760 07962
United StatesActive - Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick 5101717, New Jersey 5101760 08901
United StatesActive - Recruiting
Rutgers Cancer Institute of New Jersey at University Hospital
Newark 5101798, New Jersey 5101760 07103
United StatesActive - Recruiting
James J Peters Veterans Administration Medical Center - NAVREF
Bronx, New York 10468-3904
United StatesSite Not Available
Montefiore Medical Center
Bronx, New York 10467
United StatesActive - Recruiting
Long Island Heart Associates
Mineola, New York 11501-4298
United StatesSite Not Available
R.J. Zuckerberg Cancer Hospital/Northwell Health - BRANY - PPDS
New Hyde Park, New York 11042-1118
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesSite Not Available
NYU Langone Medical Center
New York, New York 10016-9451
United StatesActive - Recruiting
Long Island Heart Associates
Mineola 5127134, New York 5128638 11501-4298
United StatesActive - Recruiting
R.J. Zuckerberg Cancer Hospital/Northwell Health - BRANY - PPDS
New Hyde Park 5128514, New York 5128638 11042-1118
United StatesActive - Recruiting
Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029
United StatesActive - Recruiting
NYU Langone Medical Center
New York 5128581, New York 5128638 10016-9451
United StatesActive - Recruiting
James J Peters Veterans Administration Medical Center - NAVREF
The Bronx 5110266, New York 5128638 10468-3904
United StatesActive - Recruiting
Montefiore Medical Center
The Bronx 5110266, New York 5128638 10467
United StatesActive - Recruiting
Levine Cancer Institute
Charlotte, North Carolina 28204
United StatesSite Not Available
Levine Cancer Institute
Charlotte 4460243, North Carolina 4482348 28204
United StatesActive - Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
Dayton VA Medical Center - NAVREF - PPDS
Dayton, Ohio 45428-9000
United StatesSite Not Available
University Hospitals Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 44106
United StatesActive - Recruiting
Dayton VA Medical Center - NAVREF - PPDS
Dayton 4509884, Ohio 5165418 45428-9000
United StatesActive - Recruiting
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104-5020
United StatesSite Not Available
The University of Oklahoma Health Sciences Center
Oklahoma City 4544349, Oklahoma 4544379 73104-5020
United StatesActive - Recruiting
Kaiser Permanente Westside Medical Center
Hillsboro, Oregon 97124-5806
United StatesSite Not Available
OHSU Knight Cancer Institute Hematology Oncology
Portland, Oregon 97239-3011
United StatesSite Not Available
Kaiser Permanente Westside Medical Center
Hillsboro 5731371, Oregon 5744337 97124-5806
United StatesActive - Recruiting
OHSU Knight Cancer Institute Hematology Oncology
Portland 5746545, Oregon 5744337 97239-3011
United StatesActive - Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Veterans Affairs Pittsburgh Healthcare System - NAVREF - PPDS
Pittsburgh, Pennsylvania 15240
United StatesSite Not Available
Thomas Jefferson University
Philadelphia 4560349, Pennsylvania 6254927 19107
United StatesActive - Recruiting
Veterans Affairs Pittsburgh Healthcare System - NAVREF - PPDS
Pittsburgh 5206379, Pennsylvania 6254927 15240
United StatesActive - Recruiting
The West Clinic (East Campus)
Germantown, Tennessee 38138-1762
United StatesSite Not Available
Nashville General Hospital at Meharry
Nashville, Tennessee 37208-2918
United StatesSite Not Available
The West Clinic (East Campus)
Germantown 4624601, Tennessee 4662168 38138-1762
United StatesActive - Recruiting
Nashville General Hospital at Meharry
Nashville 4644585, Tennessee 4662168 37208-2918
United StatesActive - Recruiting
Liver Institute at Methodist Dallas
Dallas, Texas 75203-1260
United StatesActive - Recruiting
Moody Outpatient Center ? Parkland Health
Dallas, Texas 75235
United StatesSite Not Available
Texas Oncology (Worth) - USOR
Dallas, Texas 75246-2008
United StatesActive - Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas 75390-0001
United StatesActive - Recruiting
Texas Oncology - Denison Cancer Center
Denison, Texas 75020-0084
United StatesSite Not Available
Houston Methodist Hospital
Houston, Texas 77030
United StatesActive - Recruiting
Kelsey Research Foundation
Houston, Texas 77025-1669
United StatesActive - Recruiting
Michael E Debakey VA Medical Center - NAVREF - PPDS
Houston, Texas 77030-4211
United StatesSite Not Available
Liver Institute at Methodist Dallas
Dallas 4684888, Texas 4736286 75203-1260
United StatesActive - Recruiting
Moody Outpatient Center ? Parkland Health
Dallas 4684888, Texas 4736286 75235
United StatesActive - Recruiting
Texas Oncology (Worth) - USOR
Dallas 4684888, Texas 4736286 75246-2008
United StatesActive - Recruiting
University of Texas Southwestern Medical Center
Dallas 4684888, Texas 4736286 75390-0001
United StatesActive - Recruiting
Texas Oncology - Denison Cancer Center
Denison 4685892, Texas 4736286 75020-0084
United StatesActive - Recruiting
Houston Methodist Hospital
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting
Kelsey Research Foundation
Houston 4699066, Texas 4736286 77025-1669
United StatesActive - Recruiting
Michael E Debakey VA Medical Center - NAVREF - PPDS
Houston 4699066, Texas 4736286 77030-4211
United StatesActive - Recruiting
Intermountain Healthcare
Murray, Utah 84107-5741
United StatesSite Not Available
Intermountain Cancer Center
Saint George, Utah 84790
United StatesSite Not Available
Intermountain Healthcare
Murray 5778755, Utah 5549030 84107-5741
United StatesActive - Recruiting
Intermountain Cancer Center
St. George 5546220, Utah 5549030 84790
United StatesActive - Recruiting
Inova Schar Cancer Institute
Falls Church, Virginia 22042
United StatesSite Not Available
Maryview Hospital, Inc.
Newport News, Virginia 23602
United StatesSite Not Available
Bon Secours St. Mary's Hospital
Richmond, Virginia 23226-1925
United StatesActive - Recruiting
VCU Medical Center North Hospital
Richmond, Virginia 23298-5028
United StatesSite Not Available
Inova Schar Cancer Institute
Falls Church 4758390, Virginia 6254928 22042
United StatesActive - Recruiting
Maryview Hospital, Inc.
Newport News 4776024, Virginia 6254928 23602
United StatesActive - Recruiting
Bon Secours St. Mary's Hospital
Richmond 4781708, Virginia 6254928 23226-1925
United StatesActive - Recruiting
VCU Medical Center North Hospital
Richmond 4781708, Virginia 6254928 23298-5028
United StatesActive - Recruiting
Benaroya Research Institute at Virginia Mason
Seattle, Washington 98101-2756
United StatesActive - Recruiting
Virginia Mason Medical Center
Seattle, Washington 98101
United StatesSite Not Available
Virginia Mason Medical Center
Seattle 5809844, Washington 5815135 98101
United StatesActive - Recruiting
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