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Hepatocellular CarcinomaPhase 2KirrosNCT06096779

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

A Phase 2 study testing Atezolizumab and Bevacizumab in people with Hepatocellular Carcinoma, run by Genentech, Inc. at 54 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Atezolizumab and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
54 sitesin 2 countries
Study dates
15 Jul 2024to 30 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

54 sites in 2 countries.

54 sites in 2 countries

United States53 sites
  • LSU Health Baton Rouge

    Baton Rouge, Louisiana, 70805

  • Our Lady of the Lake Cancer Institute

    Baton Rouge, Louisiana, 70808-4300

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • Northwestern University

    Chicago, Illinois, 60611-2908

  • University of Illinois Health Outpatient Care Center

    Chicago, Illinois, 60612-4795

  • The Duchossois Center for Advanced Medicine

    Chicago, Illinois, 60637-1426

  • Liver Institute at Methodist Dallas

    Dallas, Texas, 75203-1260

  • Moody Outpatient Center ? Parkland Health

    Dallas, Texas, 75235

  • Texas Oncology (Worth) - USOR

    Dallas, Texas, 75246-2008

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390-0001

  • Dayton VA Medical Center - NAVREF - PPDS

    Dayton, Ohio, 45428-9000

  • Texas Oncology - Denison Cancer Center

    Denison, Texas, 75020-0084

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Inova Schar Cancer Institute

    Falls Church, Virginia, 22042

  • The West Clinic (East Campus)

    Germantown, Tennessee, 38138-1762

  • Hartford Healthcare Cancer Institute at Hartford Hospital

    Hartford, Connecticut, 06106

  • Kaiser Permanente Westside Medical Center

    Hillsboro, Oregon, 97124-5806

  • Kelsey Research Foundation

    Houston, Texas, 77025-1669

  • Michael E Debakey VA Medical Center - NAVREF - PPDS

    Houston, Texas, 77030-4211

  • Saint Luke?s Hospital of Kansas City

    Kansas City, Missouri, 64111

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • University of Kentucky - Markey Cancer Center

    Lexington, Kentucky, 40536-7001

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

    Los Angeles, California, 90089-5601

  • NYU Langone Hospital - Long Island

    Mineola, New York, 11501-4064

  • Intermountain Healthcare

    Murray, Utah, 84107-5741

  • Nashville General Hospital at Meharry

    Nashville, Tennessee, 37208-2918

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Rutgers Cancer Institute of New Jersey at University Hospital

    Newark, New Jersey, 07103

  • University of Southern California

    Newport Beach, California, 92663

  • The University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104-5020

  • University of California Irvine Medical Center

    Orange, California, 92868

  • Orlando Health Inc.

    Orlando, Florida, 32806

  • California Liver Research Institute

    Pasadena, California, 91105-2561

  • Jefferson Health Honickman Center

    Philadelphia, Pennsylvania, 19107

  • Veterans Affairs Pittsburgh Healthcare System - NAVREF - PPDS

    Pittsburgh, Pennsylvania, 15240

  • OHSU Knight Cancer Institute Hematology Oncology

    Portland, Oregon, 97239-3011

  • Bon Secours St. Mary's Hospital

    Richmond, Virginia, 23226-1925

  • VCU Medical Center North Hospital

    Richmond, Virginia, 23298-5028

  • University of California Davis Medical Center

    Sacramento, California, 95817

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Intermountain Cancer Center

    St. George, Utah, 84790

  • Stanford Health Care

    Stanford, California, 94305

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • James J Peters Veterans Administration Medical Center - NAVREF

    The Bronx, New York, 10468-3904

  • Harbor UCLA Medical Center

    Torrance, California, 90502-2006

  • University of Arizona Cancer Center

    Tucson, Arizona, 85724

  • George Washington University- Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

  • Washington DC VA Medical Center

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

  • Cedars Sinai Comprehensive Transplant Center

    West Hollywood, California, 90048-2422

Other trials in United States

Puerto Rico1 site
  • Pan American Center for Oncology Trials, LLC

    Rio Piedras, 00935

Other trials in Puerto Rico

About this study

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

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.

Read the detailed description

This is a Phase II, open-label, multicohort, multicenter study in participants with unresectable, locally advanced, or metastatic 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 of atezolizumab plus bevacizumab (Cohort A) or atezolizumab monotherapy (Cohort B) in this population.

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
Medical subject headings
Carcinoma, Hepatocellular, Fibrosis, Liver Neoplasms, Digestive System Neoplasms, Liver Diseases, Fatty Liver

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

    Also called Tecentriq; RO5541267

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

  • BevacizumabDrug

    Also called Avastin; RO4876646

    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.

Study groups in NCT06096779
Study groupRoleWhat they receive
Cohort A: Atezolizumab+BevacizumabExperimentalParticipants will receive atezolizumab plus bevacizumab until unacceptable toxicity or loss of clinical benefit, as determined by the investigator.
Receives: Drug: Atezolizumab; Drug: Bevacizumab
Cohort B: AtezolizumabExperimentalParticipants will receive atezolizumab until unacceptable toxicity or loss of clinical benefit, as determined by the investigator.
Receives: Drug: Atezolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2023
  2. Study start15 Jul 2024
  3. Primary completion30 Jul 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06096779
Sponsor's protocol ID
ML44719
Acronym
Kirros
Status last verified
Oct 2026
First submitted
18 Oct 2023
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atezolizumab and Bevacizumab in people with Hepatocellular Carcinoma, run by Genentech, Inc. at 54 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Adverse Events (AEs) (time frame: Baseline through the end of the study (up to approximately 36 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.

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