A Phase II, open-label, multi-cohort, multicenter study in patients with unresectable HEPATOCELLULAR CARCINOMA and CHILDPUGH B7 and B8 Cirrhosis
Primary objective:
To evaluate the safety of the study treatments in Cohorts A and B
Secondary Objectives:
To evaluate the efficacy of the study treatments in Cohorts A and B
To evaluate patient-reported tolerability of the study treatments in Cohorts A and B from the participant s perspective
Exploratory Objective:
To identify biomarkers as follows:
Those associated with response to atezolizumab + bevacizumab or atezolizumab monotherapy
Those that are early surrogates of efficacy, are associated with progression to a more severe disease state (i.e., prognostic biomarkers)
OR
Those that can increase the knowledge of disease biology and drug safety in Cohorts A and B
BEVACIZUMAB
Chemotherapy single agent systemic
- Rutgers Cancer Institute of New Jersey
- Rutgers Cancer Institute of New Jersey-University Hospital
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
- History of malignancy other than HCC within 3 years prior to screening, with the
exception of malignancies with a negligible risk of metastasis or death
- 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
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.