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Clinical Trial 19483

Cancer Type: Gastrointestinal Tumor
Interventions:Atezolizumab (Tecentriq); Avastin (Bevacizumab); BAY 43-9006 (Sorafenib); Bevacizumab; Sorafenib

Study Type: Treatment
Phase of Study: Phase III
Investigators:

  • Richard Kim

Call 813-745-6100
or 1-800-679-0775
Overview

Study 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

Summary

Objective

To evaluate the efficacy of atezolizumab + bevacizumab compared with sorafenib. OS, defined as the time from randomization to death from any cause. Objective response, defined as a complete or partial response, as determined by the investigator according to RECIST v1.1. To evaluate the efficacy of atezolizumab + bevacizumab compared with sorafenib. To evaluate the association of prespecified biomarkers with efficacy of atezolizumab + bevacizumab compared with sorafenib. To evaluate PROs of disease/treatment-related symptoms, HRQoL/GHS, and function experienced by patients on atezolizumab + bevacizumab versus sorafenib. To evaluate the efficacy of atezolizumab + bevacizumab compared with sorafenib. To evaluate PROs of disease/treatment-related symptoms, HRQoL/GHS, body image, and function, experienced by patients on atezolizumab + bevacizumab versus sorafenib. To evaluate the safety of atezolizumab + bevacizumab compared with sorafenib To characterize the PK profile of atezolizumab when given in combination with bevacizumab.

Inclusion Criteria

  • Locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC)
  • No prior systemic therapy for HCC
  • At least one measurable untreated lesion
  • Eastern Cooperative Oncology Group (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
  • Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture
  • Metastatic disease that involves major airways or blood vessels, or centrally located mediastinal tumor masses
  • Chronic daily treatment with a non-steroidal anti-inflammatory drug (NSAID)