Trial Title:
A Study Evaluating Atezolizumab, With or Without Bevacizumab, in Patients With Unresectable Hepatocellular Carcinoma and Child-Pugh B7 and B8 Cirrhosis
NCT ID:
NCT06096779
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Fibrosis
Bevacizumab
Atezolizumab
Conditions: Keywords:
Cirrhosis
liver cancer
liver tumor
Child-Pugh B
hepatocellular carcinoma
atezolizumab
bevacizumab
Immune Checkpoint Inhibitor
Digestive System Neoplasms
Kirros
ML44719
liver disease
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Atezolizumab
Description:
Atezolizumab will be administered at a dose of 1200 mg by IV infusion on Day 1 of each
21-day cycle.
Arm group label:
Cohort A: Atezolizumab+Bevacizumab
Arm group label:
Cohort B: Atezolizumab
Other name:
Tecentriq
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
Bevacizumab will be administered at a dose of 15 mg/kg by IV infusion on Day 1 of each
21-day cycle.
Arm group label:
Cohort A: Atezolizumab+Bevacizumab
Other name:
Avastin
Summary:
The purpose of this study is to assess the safety and efficacy 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 hepatocellular carcinoma (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 and
efficacy of atezolizumab plus bevacizumab (Cohort A) or atezolizumab monotherapy (Cohort
B) in this population.
Criteria for eligibility:
Criteria:
General Inclusion Criteria:
- Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by
histology/cytology or clinically by American Association for the Study of Liver
Diseases (AASLD) criteria in cirrhotic patients
- Disease that is not amenable to curative surgical and/or locoregional therapies
- No prior systemic treatment (including systemic investigational agents) for locally
advanced 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 study
treatment
- Adequate hematologic and end-organ function
- Life expectancy of at least 12 weeks
- Female participants of childbearing potential must be willing to avoid pregnancy and
egg donation
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 study
treatment
- Treatment with locoregional therapy to liver within 28 days prior to initiation of
study 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 of
study treatment
- Inadequately controlled hypertension
- 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 (CT) scan
- Patients who have a known concurrent malignancy that is progressing or requires
active treatment, who have not completely recovered from treatment, or who have a
significant malignancy history that, in the opinion of the investigator, should
preclude participation.
- Known fibrolamellar HCC, sarcomatoid HCC, other rare HCC variant, or mixed
cholangiocarcinoma and HCC
- Symptomatic, untreated, or actively progressing central nervous system (CNS)
metastases
- Prior allogeneic stem cell or solid organ transplantation
- 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 or
that are at high risk for bleeding
- A prior bleeding event due to esophageal and/or gastric varices within 6 months
prior to initiation of study treatment
- Grade ≥3 hemorrhage or bleeding event within 6 months prior to initiation of study
treatment
- History of hepatic encephalopathy requiring hospitalization or treatment escalation
within 6 months prior to study treatment, or any continued symptoms of
encephalopathy despite medical management
- History, planned, or recommended placement of transjugular intrahepatic
portosystemic shunt (TIPS)
- History of ascites requiring therapeutic paracentesis over the last 3 months
- History of spontaneous bacterial peritonitis within last 12 months
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Southern California-Keck School of Medicine -1975 Zonal Ave
Address:
City:
Los Angeles
Zip:
90089-5601
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Southern California; Oncology/Hematology
Address:
City:
Newport Beach
Zip:
92663
Country:
United States
Status:
Recruiting
Facility:
Name:
University of California Irvine Medical Center
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Recruiting
Facility:
Name:
California Liver Research Institute
Address:
City:
Pasadena
Zip:
91105-2561
Country:
United States
Status:
Recruiting
Facility:
Name:
University of California Davis Medical Center
Address:
City:
Sacramento
Zip:
95817
Country:
United States
Status:
Recruiting
Facility:
Name:
Stanford Health Care
Address:
City:
Stanford
Zip:
94305
Country:
United States
Status:
Recruiting
Facility:
Name:
Harbor UCLA Medical Center
Address:
City:
Torrance
Zip:
90502-2006
Country:
United States
Status:
Recruiting
Facility:
Name:
Rocky Mountain Cancer Centers (Williams) - USOR
Address:
City:
Denver
Zip:
80218-1237
Country:
United States
Status:
Recruiting
Facility:
Name:
Hartford Healthcare Cancer Institute at Hartford Hospital
Address:
City:
Hartford
Zip:
06106
Country:
United States
Status:
Recruiting
Facility:
Name:
Orlando Health Inc.
Address:
City:
Orlando
Zip:
32806
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Kentucky - Markey Cancer Center
Address:
City:
Lexington
Zip:
40536-7001
Country:
United States
Status:
Recruiting
Facility:
Name:
LSU Health Baton Rouge; North Clinic
Address:
City:
Baton Rouge
Zip:
70805
Country:
United States
Status:
Recruiting
Facility:
Name:
Our Lady of the Lake Physician Group
Address:
City:
Baton Rouge
Zip:
70808-4375
Country:
United States
Status:
Recruiting
Facility:
Name:
Barbara Ann Karmanos Cancer Institute
Address:
City:
Detroit
Zip:
48201-2013
Country:
United States
Status:
Recruiting
Facility:
Name:
Henry Ford Health System
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Recruiting
Facility:
Name:
Saint Luke?s Hospital of Kansas City
Address:
City:
Kansas City
Zip:
64111
Country:
United States
Status:
Recruiting
Facility:
Name:
Rutgers Cancer Institute of New Jersey
Address:
City:
New Brunswick
Zip:
08901
Country:
United States
Status:
Recruiting
Facility:
Name:
Rutgers Cancer Institute of New Jersey at University Hospital
Address:
City:
Newark
Zip:
07103
Country:
United States
Status:
Recruiting
Facility:
Name:
Montefiore Medical Center
Address:
City:
Bronx
Zip:
10467
Country:
United States
Status:
Recruiting
Facility:
Name:
Long Island Heart Associates
Address:
City:
Mineola
Zip:
11501-4298
Country:
United States
Status:
Recruiting
Facility:
Name:
NYU Langone Medical Center
Address:
City:
New York
Zip:
10016-9451
Country:
United States
Status:
Recruiting
Facility:
Name:
Levine Cancer Institute
Address:
City:
Charlotte
Zip:
28204
Country:
United States
Status:
Recruiting
Facility:
Name:
University Hospitals Cleveland Medical Center
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Recruiting
Facility:
Name:
Dayton VA Medical Center - NAVREF - PPDS
Address:
City:
Dayton
Zip:
45428-9000
Country:
United States
Status:
Recruiting
Facility:
Name:
The University of Oklahoma Health Sciences Center
Address:
City:
Oklahoma City
Zip:
73104-5020
Country:
United States
Status:
Recruiting
Facility:
Name:
Kaiser Permanente Westside Medical Center
Address:
City:
Hillsboro
Zip:
97124-5806
Country:
United States
Status:
Recruiting
Facility:
Name:
Thomas Jefferson University
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Status:
Recruiting
Facility:
Name:
Veterans Affairs Pittsburgh Healthcare System - NAVREF - PPDS
Address:
City:
Pittsburgh
Zip:
15240
Country:
United States
Status:
Recruiting
Facility:
Name:
The West Clinic (East Campus)
Address:
City:
Germantown
Zip:
38138-1762
Country:
United States
Status:
Recruiting
Facility:
Name:
Nashville General Hospital at Meharry
Address:
City:
Nashville
Zip:
37208-2918
Country:
United States
Status:
Recruiting
Facility:
Name:
Liver Institute at Methodist Dallas
Address:
City:
Dallas
Zip:
75203-1260
Country:
United States
Status:
Recruiting
Facility:
Name:
Texas Oncology (Worth) - USOR
Address:
City:
Dallas
Zip:
75246-2008
Country:
United States
Status:
Recruiting
Facility:
Name:
Texas Oncology - Denison Cancer Center
Address:
City:
Denison
Zip:
75020-0084
Country:
United States
Status:
Recruiting
Facility:
Name:
Kelsey Research Foundation
Address:
City:
Houston
Zip:
77025-1669
Country:
United States
Status:
Recruiting
Facility:
Name:
Houston Methodist Hospital
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Intermountain Healthcare
Address:
City:
Murray
Zip:
84107
Country:
United States
Status:
Recruiting
Facility:
Name:
Intermountain Cancer Center
Address:
City:
Saint George
Zip:
84790
Country:
United States
Status:
Recruiting
Facility:
Name:
Inova Schar Cancer Institute
Address:
City:
Falls Church
Zip:
22042
Country:
United States
Status:
Recruiting
Facility:
Name:
Maryview Hospital, Inc.
Address:
City:
Newport News
Zip:
23602
Country:
United States
Status:
Recruiting
Facility:
Name:
Bon Secours St. Mary's Hospital
Address:
City:
Richmond
Zip:
23226-1925
Country:
United States
Status:
Recruiting
Facility:
Name:
VCU Medical Center North Hospital
Address:
City:
Richmond
Zip:
23298-5028
Country:
United States
Status:
Recruiting
Facility:
Name:
Benaroya Research Institute at Virginia Mason
Address:
City:
Seattle
Zip:
98101-2756
Country:
United States
Status:
Recruiting
Facility:
Name:
Pan American Center for Oncology Trials, LLC
Address:
City:
Rio Piedras
Zip:
00935
Country:
Puerto Rico
Status:
Recruiting
Start date:
July 15, 2024
Completion date:
November 16, 2026
Lead sponsor:
Agency:
Genentech, Inc.
Agency class:
Industry
Source:
Genentech, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06096779
