A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma [IMbrave150]

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

Summary:

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.

Trial Description

Primary Outcome:

  • Overall Survival (OS)
  • Progression Free Survival (PFS) as Determined by an Independent Review Facility (IRF) According to Response Evalutaion Criteria in Solid Tumours (RECIST) v1.1
Secondary Outcome:
  • Objective Response (OR) defined as complete response or partial response as determined by the Investigator according to RECIST V1.1
  • Progression Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1
  • Time to Progression (TTP) as Determined by an Investigator According to RECIST v1.1
  • Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1
  • OR defined as complete or partial response as Determined by an IRF According to RECIST v1.1
  • TTP as Determined by an IRF According to RECIST v1.1
  • DOR as Determined by an IRF According to RECIST v1.1
  • OR defined as complete or partial response, as Determined by an IRF According to Hepatocellular Carcinoma Modified RECIST (HCC mRECIST)
  • PFS as Determined by an IRF According to HCC mRECIST
  • TTP as Determined by an IRF According to HCC mRECIST
  • DOR as Determined by an IRF According to HCC mRECIST
  • Time to Deterioration (TTD) in Patient-Reported GHS/QoL, physical functioning, and role functioning, as determined by European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Score
  • PFS as determined by the investigator according to RECIST v1.1
  • Serum Concentration of Atezolizumab
  • Change from Baseline in Anti-Drug Antibodies (ADAs) to Atezolizumab
  • Percentage of Participants with Adverse Events
  • PFS as Determined by an IRF According to RECIST v1.1
  • OS
The participants will be randomized in a 2:1 ratio to one of the two treatment arms: Arm A (experimental arm): Atezolizumab +bevacizumab; Arm B (control arm): Sorafenib

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society