RECRUITING

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

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Conditions

Hepatocellular CarcinomaCirrhosisLiver CancerLiver TumorChild-pugh BAtezolizumabBevacizumabImmune Checkpoint InhibitorDigestive System NeoplasmsKirrosML44719Liver DiseaseGenentechImmunotherapyCPBCPB 7CPB 8TecentriqAvastinHCCCirrhotic LiverFatty Liver

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-07-15
Study Completion:2027-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06096779

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Disease that is not amenable to curative surgical and/or locoregional therapies
  3. * No prior systemic treatment (including systemic investigational agents) for locally advanced or metastatic and/or unresectable HCC
  4. * Measurable disease (at least one untreated target lesion) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
  5. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 7 days prior to initiation of study treatment
  6. * Child-pugh B7 or B8 cirrhosis at screening and within 7 days prior to study treatment
  7. * Adequate hematologic and end-organ function
  8. * Life expectancy of at least 12 weeks
  9. * Female participants of childbearing potential must be willing to avoid pregnancy and egg donation
  10. * Absolute neutrophil count ≥1.0 x 10\^9 per liter (/L) (≥1000 per microliter \[/μL\]) without granulocyte colony-stimulating factor support
  11. * Platelet count ≥ 50 × 109/L (50,000/μL) without transfusion
  12. * 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)
  13. * Serum bilirubin ≤ 3 × ULN
  14. * Creatinine clearance ≥ 50 milliliters per minute (mL/min) (calculated using the Cockcroft-gault formula)
  15. * Serum albumin ≥ 20 g/L (2.0 g/dL) without transfusion in the prior 3 months
  16. * International normalized ratio (INR) ≤2.3
  1. * Pregnancy or breastfeeding
  2. * Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies
  3. * Treatment with investigational therapy within 28 days prior to initiation of study treatment
  4. * 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
  5. * Treatment with systemic immunostimulatory agents
  6. * Treatment with systemic immunosuppressive medication
  7. * Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment
  8. * Inadequately controlled hypertension
  9. * Active or history of autoimmune disease or immune deficiency
  10. * 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
  11. * 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
  12. * Participants on preventative hormonal therapies (i.e., tamoxifen and other hormonal inhibitors) are not excluded
  13. * Known fibrolamellar HCC, sarcomatoid HCC, other rare HCC variant, or mixed cholangiocarcinoma and HCC
  14. * Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
  15. * Prior allogeneic stem cell or solid organ transplantation
  16. * Actively listed for liver transplantation
  17. * Co-infection with hepatitis B virus (HBV) and hepatitis C virus (HCV)
  18. * Untreated or incompletely treated esophageal and/or gastric varices with bleeding or that are at high risk for bleeding
  19. * A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment
  20. * Grade ≥3 hemorrhage or bleeding event within 6 months prior to initiation of study treatment
  21. * Hepatic encephalopathy is allowed if no active symptoms or stable within 3 months of study treatment
  22. * History, planned, or recommended placement of transjugular intrahepatic portosystemic shunt (TIPS) is excluded from Cohort A only. TIPS is acceptable in Cohort B
  23. * Diagnostic paracentesis is allowed. Therapeutic paracentesis: one large volume paracentesis prior to enrollment with diuretic controlled ascites is allowed.
  24. * Participants with ascites controlled on diuretics are allowed
  25. * History of spontaneous bacterial peritonitis within last 12 months

Contacts and Locations

Study Contact

Reference Study ID Number: ML44719 https://forpatients.roche.com/
CONTACT
888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com

Principal Investigator

Clinical Trials
STUDY_DIRECTOR
Hoffmann-La Roche

Study Locations (Sites)

University of Arizona Cancer Center
Tucson, Arizona, 85724
United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093
United States
University of Southern California-Keck School of Medicine -1975 Zonal Ave
Los Angeles, California, 90089-5601
United States
University of Southern California
Newport Beach, California, 92663
United States
University of California Irvine Medical Center
Orange, California, 92868
United States
California Liver Research Institute
Pasadena, California, 91105-2561
United States
University of California Davis Medical Center
Sacramento, California, 95817
United States
Stanford Health Care
Stanford, California, 94305
United States
Harbor UCLA Medical Center
Torrance, California, 90502-2006
United States
Cedars Sinai Comprehensive Transplant Center
West Hollywood, California, 90048-2422
United States
Rocky Mountain Cancer Centers (Williams) - USOR
Denver, Colorado, 80218-1237
United States
Hartford Healthcare Cancer Institute at Hartford Hospital
Hartford, Connecticut, 06106
United States
Washington DC VA Medical Center
Washington D.C., District of Columbia, 20422-0001
United States
Orlando Health Inc.
Orlando, Florida, 32806
United States
Northwestern University
Chicago, Illinois, 60611-2908
United States
University of Illinois Health Outpatient Care Center
Chicago, Illinois, 60612-4795
United States
The Duchossois Center for Advanced Medicine
Chicago, Illinois, 60637-1426
United States
University of Kentucky - Markey Cancer Center
Lexington, Kentucky, 40536-7001
United States
LSU Health Baton Rouge
Baton Rouge, Louisiana, 70805
United States
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, 70808-4375
United States
Tufts Medical Center
Boston, Massachusetts, 02111
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Veterans Affairs Ann Arbor Healthcare System
Ann Arbor, Michigan, 48105
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Henry Ford Health System
Detroit, Michigan, 48202
United States
Saint Luke?s Hospital of Kansas City
Kansas City, Missouri, 64111
United States
MorristownMedicalCenter
Morristown, New Jersey, 07962
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
Rutgers Cancer Institute of New Jersey at University Hospital
Newark, New Jersey, 07103
United States
Long Island Heart Associates
Mineola, New York, 11501-4298
United States
R.J. Zuckerberg Cancer Hospital/Northwell Health - BRANY - PPDS
New Hyde Park, New York, 11042-1118
United States
NYU Langone Medical Center
New York, New York, 10016-9451
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
Montefiore Medical Center
The Bronx, New York, 10467
United States
James J Peters Veterans Administration Medical Center - NAVREF
The Bronx, New York, 10468-3904
United States
Levine Cancer Institute
Charlotte, North Carolina, 28204
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Dayton VA Medical Center - NAVREF - PPDS
Dayton, Ohio, 45428-9000
United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104-5020
United States
Kaiser Permanente Westside Medical Center
Hillsboro, Oregon, 97124-5806
United States
OHSU Knight Cancer Institute Hematology Oncology
Portland, Oregon, 97239-3011
United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107-5109
United States
Veterans Affairs Pittsburgh Healthcare System - NAVREF - PPDS
Pittsburgh, Pennsylvania, 15240
United States
The West Clinic (East Campus)
Germantown, Tennessee, 38138-1762
United States
Nashville General Hospital at Meharry
Nashville, Tennessee, 37208-2918
United States
Liver Institute at Methodist Dallas
Dallas, Texas, 75203-1260
United States
Moody Outpatient Center ? Parkland Health
Dallas, Texas, 75235
United States
Texas Oncology (Worth) - USOR
Dallas, Texas, 75246-2008
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-0001
United States
Texas Oncology - Denison Cancer Center
Denison, Texas, 75020-0084
United States
Kelsey Research Foundation
Houston, Texas, 77025-1669
United States
Michael E Debakey VA Medical Center - NAVREF - PPDS
Houston, Texas, 77030-4211
United States
Houston Methodist Hospital
Houston, Texas, 77030
United States
Intermountain Healthcare
Murray, Utah, 84107-5741
United States
Intermountain Cancer Center
St. George, Utah, 84790
United States
Inova Schar Cancer Institute
Falls Church, Virginia, 22042
United States
Maryview Hospital, Inc.
Newport News, Virginia, 23602
United States
Bon Secours St. Mary's Hospital
Richmond, Virginia, 23226-1925
United States
VCU Medical Center North Hospital
Richmond, Virginia, 23298-5028
United States
Virginia Mason Medical Center
Seattle, Washington, 98101
United States

Collaborators and Investigators

Sponsor: Genentech, Inc.

  • Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-15
Study Completion Date2027-12-30

Study Record Updates

Study Start Date2024-07-15
Study Completion Date2027-12-30

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • Hepatocellular Carcinoma