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RECRUITING

NCT06096779

PHASE2

A Study Evaluating Atezolizumab, With or Without Bevacizumab, in Participants With Unresectable Hepatocellular Carcinoma and Child-pugh B7 and B8 Cirrhosis

Sponsor: Genentech, Inc.

View on ClinicalTrials.gov

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.

Official title: A Phase II, Open-label, Multi-cohort, Multicenter Study in Patients With Unresectable Hepatocellular Carcinoma and Child-pugh B7 and B8 Cirrhosis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-07-15

Completion Date

2027-12-30

Last Updated

2026-04-03

Healthy Volunteers

Conditions

Hepatocellular Carcinoma

Interventions

DRUG

Atezolizumab

Atezolizumab will be administered at a dose of 1200 milligrams (mg) by intravenous (IV) infusion on Day 1 of each 21-day cycle.

DRUG

Bevacizumab

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.

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 participants * 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 Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) * Eastern Cooperative Oncology Group (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 * Absolute neutrophil count ≥1.0 x 10\^9 per liter (/L) (≥1000 per microliter \[/μL\]) without granulocyte colony-stimulating factor support * Platelet count ≥ 50 × 109/L (50,000/μL) without transfusion * Hemoglobin ≥ 80 grams per liter (g/L) (8 grams per deciliter \[g/dL\]) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 × upper limit of normal (ULN) * Serum bilirubin ≤ 3 × ULN * Creatinine clearance ≥ 50 milliliters per minute (mL/min) (calculated using the Cockcroft-gault formula) * Serum albumin ≥ 20 g/L (2.0 g/dL) without transfusion in the prior 3 months * International normalized ratio (INR) ≤2.3 General Exclusion Criteria: * Pregnancy or breastfeeding * Prior treatment with cluster of differentiation 137 (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 * Participants 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 * Participants on preventative hormonal therapies (i.e., tamoxifen and other hormonal inhibitors) are not excluded * 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 * 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 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 * Hepatic encephalopathy is allowed if no active symptoms or stable within 3 months of study treatment * History, planned, or recommended placement of transjugular intrahepatic portosystemic shunt (TIPS) is excluded from Cohort A only. TIPS is acceptable in Cohort B * Diagnostic paracentesis is allowed. Therapeutic paracentesis: one large volume paracentesis prior to enrollment with diuretic controlled ascites is allowed. * Participants with ascites controlled on diuretics are allowed * History of spontaneous bacterial peritonitis within last 12 months

Locations (61)

University of Arizona Cancer Center

Tucson, Arizona, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

University of Southern California-Keck School of Medicine -1975 Zonal Ave

Los Angeles, California, United States

University of Southern California

Newport Beach, California, United States

University of California Irvine Medical Center

Orange, California, United States

California Liver Research Institute

Pasadena, California, United States

University of California Davis Medical Center

Sacramento, California, United States

Stanford Health Care

Stanford, California, United States

Harbor UCLA Medical Center

Torrance, California, United States

Cedars Sinai Comprehensive Transplant Center

West Hollywood, California, United States

Rocky Mountain Cancer Centers (Williams) - USOR

Denver, Colorado, United States

Hartford Healthcare Cancer Institute at Hartford Hospital

Hartford, Connecticut, United States

Washington DC VA Medical Center

Washington D.C., District of Columbia, United States

Orlando Health Inc.

Orlando, Florida, United States

Northwestern University

Chicago, Illinois, United States

University of Illinois Health Outpatient Care Center

Chicago, Illinois, United States

The Duchossois Center for Advanced Medicine

Chicago, Illinois, United States

University of Kentucky - Markey Cancer Center

Lexington, Kentucky, United States

LSU Health Baton Rouge

Baton Rouge, Louisiana, United States

Our Lady of the Lake Cancer Institute

Baton Rouge, Louisiana, United States

Tufts Medical Center

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Veterans Affairs Ann Arbor Healthcare System

Ann Arbor, Michigan, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Henry Ford Health System

Detroit, Michigan, United States

Saint Luke?s Hospital of Kansas City

Kansas City, Missouri, United States

MorristownMedicalCenter

Morristown, New Jersey, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Rutgers Cancer Institute of New Jersey at University Hospital

Newark, New Jersey, United States

Long Island Heart Associates

Mineola, New York, United States

R.J. Zuckerberg Cancer Hospital/Northwell Health - BRANY - PPDS

New Hyde Park, New York, United States

NYU Langone Medical Center

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

James J Peters Veterans Administration Medical Center - NAVREF

The Bronx, New York, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Dayton VA Medical Center - NAVREF - PPDS

Dayton, Ohio, United States

The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Kaiser Permanente Westside Medical Center

Hillsboro, Oregon, United States

OHSU Knight Cancer Institute Hematology Oncology

Portland, Oregon, United States

Jefferson Health Honickman Center

Philadelphia, Pennsylvania, United States

Veterans Affairs Pittsburgh Healthcare System - NAVREF - PPDS

Pittsburgh, Pennsylvania, United States

The West Clinic (East Campus)

Germantown, Tennessee, United States

Nashville General Hospital at Meharry

Nashville, Tennessee, United States

Liver Institute at Methodist Dallas

Dallas, Texas, United States

Moody Outpatient Center ? Parkland Health

Dallas, Texas, United States

Texas Oncology (Worth) - USOR

Dallas, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Texas Oncology - Denison Cancer Center

Denison, Texas, United States

Kelsey Research Foundation

Houston, Texas, United States

Michael E Debakey VA Medical Center - NAVREF - PPDS

Houston, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

Intermountain Healthcare

Murray, Utah, United States

Intermountain Cancer Center

St. George, Utah, United States

Inova Schar Cancer Institute

Falls Church, Virginia, United States

Maryview Hospital, Inc.

Newport News, Virginia, United States

Bon Secours St. Mary's Hospital

Richmond, Virginia, United States

VCU Medical Center North Hospital

Richmond, Virginia, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Pan American Center for Oncology Trials, LLC

Rio Piedras, Puerto Rico

Clinical Research Directory

A Study Evaluating Atezolizumab, With or Without Bevacizumab, in Participants With Unresectable Hepatocellular Carcinoma and Child-pugh B7 and B8 Cirrhosis

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (61)