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

NCT06096779 | Recruiting Phase 2 FDA Drug

• 1 other identifier: ML44719
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 61

Brief 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.

Conditions

Hepatocellular Carcinoma

Keywords

Cirrhosis; Liver Cancer; Liver Tumor; Child-pugh B; Hepatocellular Carcinoma; Atezolizumab; Bevacizumab; Immune Checkpoint Inhibitor; Digestive System Neoplasms; Kirros; ML44719; Liver Disease; Genentech; Immunotherapy; CPB; CPB 7; CPB 8; Tecentriq; Avastin; HCC; Cirrhotic Liver; Fatty Liver

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline through the end of the study (up to approximately 36 months)

Study Arms (2)

Cohort A: Atezolizumab+Bevacizumab

EXPERIMENTAL

Participants will receive atezolizumab plus bevacizumab until unacceptable toxicity or loss of clinical benefit, as determined by the investigator.

Drug: Atezolizumab; Drug: Bevacizumab

Cohort B: Atezolizumab

EXPERIMENTAL

Participants will receive atezolizumab until unacceptable toxicity or loss of clinical benefit, as determined by the investigator.

Drug: Atezolizumab

Interventions

Atezolizumab DRUG

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

Also known as: Tecentriq; RO5541267

Cohort A: Atezolizumab+Bevacizumab; Cohort B: Atezolizumab

Bevacizumab DRUG

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.

Also known as: Avastin; RO4876646

Cohort A: Atezolizumab+Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (61)

University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

RECRUITING

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

RECRUITING

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

Los Angeles, California, 90089-5601, United States

RECRUITING

University of Southern California

Newport Beach, California, 92663, United States

RECRUITING

University of California Irvine Medical Center

Orange, California, 92868, United States

COMPLETED

California Liver Research Institute

Pasadena, California, 91105-2561, United States

RECRUITING

University of California Davis Medical Center

Sacramento, California, 95817, United States

COMPLETED

Stanford Health Care

Stanford, California, 94305, United States

RECRUITING

Harbor UCLA Medical Center

Torrance, California, 90502-2006, United States

RECRUITING

Cedars Sinai Comprehensive Transplant Center

West Hollywood, California, 90048-2422, United States

RECRUITING

Rocky Mountain Cancer Centers (Williams) - USOR

Denver, Colorado, 80218-1237, United States

RECRUITING

Hartford Healthcare Cancer Institute at Hartford Hospital

Hartford, Connecticut, 06106, United States

RECRUITING

Washington DC VA Medical Center

Washington D.C., District of Columbia, 20422-0001, United States

RECRUITING

Orlando Health Inc.

Orlando, Florida, 32806, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611-2908, United States

RECRUITING

University of Illinois Health Outpatient Care Center

Chicago, Illinois, 60612-4795, United States

RECRUITING

The Duchossois Center for Advanced Medicine

Chicago, Illinois, 60637-1426, United States

RECRUITING

University of Kentucky - Markey Cancer Center

Lexington, Kentucky, 40536-7001, United States

RECRUITING

LSU Health Baton Rouge

Baton Rouge, Louisiana, 70805, United States

RECRUITING

Our Lady of the Lake Cancer Institute

Baton Rouge, Louisiana, 70808-4300, United States

RECRUITING

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Veterans Affairs Ann Arbor Healthcare System

Ann Arbor, Michigan, 48105, United States

RECRUITING

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

Henry Ford Health System

Detroit, Michigan, 48202, United States

RECRUITING

Saint Luke?s Hospital of Kansas City

Kansas City, Missouri, 64111, United States

RECRUITING

MorristownMedicalCenter

Morristown, New Jersey, 07962, United States

RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

RECRUITING

Rutgers Cancer Institute of New Jersey at University Hospital

Newark, New Jersey, 07103, United States

RECRUITING

Long Island Heart Associates

Mineola, New York, 11501-4298, United States

RECRUITING

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

New Hyde Park, New York, 11042-1118, United States

WITHDRAWN

NYU Langone Medical Center

New York, New York, 10016-9451, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

James J Peters Veterans Administration Medical Center - NAVREF

The Bronx, New York, 10468-3904, United States

RECRUITING

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

WITHDRAWN

Dayton VA Medical Center - NAVREF - PPDS

Dayton, Ohio, 45428-9000, United States

RECRUITING

The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104-5020, United States

RECRUITING

Kaiser Permanente Westside Medical Center

Hillsboro, Oregon, 97124-5806, United States

RECRUITING

OHSU Knight Cancer Institute Hematology Oncology

Portland, Oregon, 97239-3011, United States

RECRUITING

Jefferson Health Honickman Center

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Veterans Affairs Pittsburgh Healthcare System - NAVREF - PPDS

Pittsburgh, Pennsylvania, 15240, United States

COMPLETED

The West Clinic (East Campus)

Germantown, Tennessee, 38138-1762, United States

ACTIVE NOT RECRUITING

Nashville General Hospital at Meharry

Nashville, Tennessee, 37208-2918, United States

RECRUITING

Liver Institute at Methodist Dallas

Dallas, Texas, 75203-1260, United States

RECRUITING

Moody Outpatient Center ? Parkland Health

Dallas, Texas, 75235, United States

RECRUITING

Texas Oncology (Worth) - USOR

Dallas, Texas, 75246-2008, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-0001, United States

RECRUITING

Texas Oncology - Denison Cancer Center

Denison, Texas, 75020-0084, United States

RECRUITING

Kelsey Research Foundation

Houston, Texas, 77025-1669, United States

RECRUITING

Michael E Debakey VA Medical Center - NAVREF - PPDS

Houston, Texas, 77030-4211, United States

RECRUITING

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

Intermountain Healthcare

Murray, Utah, 84107-5741, United States

RECRUITING

Intermountain Cancer Center

St. George, Utah, 84790, United States

RECRUITING

Inova Schar Cancer Institute

Falls Church, Virginia, 22042, United States

COMPLETED

Maryview Hospital, Inc.

Newport News, Virginia, 23602, United States

WITHDRAWN

Bon Secours St. Mary's Hospital

Richmond, Virginia, 23226-1925, United States

RECRUITING

VCU Medical Center North Hospital

Richmond, Virginia, 23298-5028, United States

RECRUITING

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

RECRUITING

Pan American Center for Oncology Trials, LLC

Rio Piedras, 00935, Puerto Rico

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Fibrosis; Liver Neoplasms; Digestive System Neoplasms; Liver Diseases; Fatty Liver

Interventions

atezolizumab; Bevacizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: ML44719 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. and Canada); global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 24, 2023
• Study Start: July 15, 2024
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

PR (1); US (60)