A Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab

Titre officiel

A Phase III, Open-Label, Randomized Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab

Sommaire:

This is a Phase III, open label, randomized, two-arm, multicentre study designed to evaluate the safety and efficacy of atezolizumab plus lenvatinib or sorafenib versus lenvatinib or sorafenib alone in locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) participants who have progressed following prior HCC treatment with atezolizumab and bevacizumab combination.

Description de l'essai

Primary Outcome:

• Overall Survival (OS)

• Progression Free Survival (PFS)
• Confirmed Objective Response Rate (ORR)
• Time to Progression (TTP)
• Duration of Response (DOR)
• Time to deterioration (TTD)
• Percentage of Participants With Adverse Events
• Percentage of Participants With Adverse Events for Combination Treatment, Adverse Events Related to Atezolizumab, and TKI-Related Adverse Events
• Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
• Serum Concentration of Atezolizumab

Voir cet essai sur ClinicalTrials.gov