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A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma [IMbrave150]
Overall Recruitment Status: Active, currently enrolling
 
Official Title
A Phase III, Open-Label, Randomized Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
 
Region Sponsors
California - Northern
Hoffmann-La Roche
 
Acronym KP IRB No.
CN-18-3188
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Individuals with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC)
 
Purpose
This study will evaluate the efficacy and safety of atezolizumab in combination with bevacizumab compared with sorafenib in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have received no prior systemic treatment.
 
Detailed Description
This is a Phase III, randomized, multicenter, open-label, two-arm study designed to evaluate the efficacy and safety of atezolizumab ? bevacizumab versus sorafenib in patients with locally advanced or metastatic HCC who have received no prior systemic treatment. This study will enroll approximately 480 patients randomized in a 2:1 ratio to one of two treatment arms: Arm A (experimental arm): Atezolizumab 1200 mg IV infusions Q3W (dosed in 3-week cycles) + bevacizumab 15 mg/kg Q3W (dosed in 3-week cycles), and Arm B (control arm): Sorafenib 400 mg by mouth (PO), twice per day (BID), continuously. Patients will receive atezolizumab and/or bevacizumab or sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, and clinical status (e.g., symptomatic deterioration such as pain secondary to disease). In the absence of unacceptable toxicity, patients who meet criteria for disease progression per RECIST v1.1 while receiving atezolizumab and/or bevacizumab or sorafenib will be permitted to continue the study treatment if they meet all criteria. Tumor assessments will be performed at baseline and at regular intervals during study treatment. Additional scans will be performed as clinically indicated. Tumor assessments will continue until disease progression, regardless of whether treatment has been discontinued (e.g., for toxicity). Patients who meet RECIST v1.1 criteria for progression will undergo tumor assessments until disease progression (per immune-modified RECIST [imRECIST]) or loss of clinical benefit, whichever occurs later. In the absence of disease progression, tumor assessments should continue regardless of whether patients start new anti-cancer therapy, until consent is withdrawn, death, or the study is terminated by the Sponsor, whichever occurs first. Following disease progression, patients will be followed for survival and subsequent anti-cancer therapies until death, loss to follow-up, withdrawal of consent, or study termination by Sponsor, whichever occurs first.
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • Locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC)
  • No prior systemic therapy for HCC
  • At least one measurable untreated lesion
  • ECOG Performance Status of 0 or 1
  • Adequate hematologic and end-organ function
  • For women of childbearing potential: agreement to remain abstinent
  • For men: agreement to remain abstinent
  • Child-Pugh class A
 
Exclusion Criteria
  • History of leptomeningeal disease
  • 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 scan
  • Active tuberculosis
  • History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
  • Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within at least 5 months after the last dose of atezolizumab, 6 months after the last dose of bevacizumab, or 1 month after the last dose of sorafenib
  • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
  • Patients with untreated or incompletely treated varices with bleeding or high-risk for bleeding
  • Moderate or severe ascites
  • History of hepatic encephalopathy
  • Co-infection of HBV and HCV
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
  • Uncontrolled tumor-related pain
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
  • Uncontrolled or symptomatic hypercalcemia
  • Treatment with systemic immunostimulatory agents
  • Inadequately controlled arterial hypertension
  • Prior history of hypertensive crisis or hypertensive encephalopathy
  • Evidence of bleeding diathesis or significant coagulopathy
  • History of intestinal obstruction and/or clinical signs or symptoms of GI obstruction including sub-occlusive disease related to the underlying disease or requirement for routine parenteral hydration
  • Please contact study team for more eligibility criteria

 
Keywords and/or Specific Medical Conditions
  • Oncology (Adult)
  • Liver Diseases
  • Adenocarcinoma
  • Liver Neoplasms
  • Angiogenesis Inhibitors
  • Micronutrients
  • Angiogenesis Modulating Agents
  • Molecular Mechanisms of Pharmacological Action
  • Antibodies, Monoclonal
  • Neoplasms
  • Antineoplastic Agents
  • Neoplasms by Histologic Type
  • Atezolizumab
  • Neoplasms by Site
  • Bevacizumab
  • Neoplasms, Glandular and Epithelial
  • Carcinoma, Hepatocellular
  • Niacinamide
  • Digestive System Diseases
  • Physiological Effects of Drugs
  • Digestive System Neoplasms
  • Protein Kinase Inhibitors
  • Enzyme Inhibitors
  • Sorafenib
  • Growth Inhibitors
  • Vitamin B Complex
  • Growth Substances
  • Vitamins
  • Immunologic Factors
  • Carcinoma
 
KP Clinical Facility
  • Diablo Medical Center-Walnut Creek
  • Hayward Medical Center
  • Oakland Medical Center
  • Roseville Medical Center
  • Sacramento Medical Center
  • San Francisco Medical Center
  • Santa Clara Medical Center-Homestead
  • Santa Teresa Medical Center-San Jose
  • South San Francisco Medical Center
  • Vallejo Medical Center
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Jennifer Suga, MD
Contact Information:
- Desiree Goldstein
-Desiree.Goldstein@kp.org
-Vallejo Medical Center


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