MO42541: IMbrave251 - Atezolizumab + lenvatinib/sorafenib in 2L HCC

• Research type

  Research Study

• Full title

  A PHASE III, OPEN-LABEL, RANDOMISED STUDY OF ATEZOLIZUMAB WITH LENVATINIB OR SORAFENIB VERSUS LENVATINIB OR SORAFENIB ALONE IN HEPATOCELLULAR CARCINOMA PREVIOUSLY TREATED WITH ATEZOLIZUMAB AND BEVACIZUMAB

• IRAS ID

  1003609

• Contact name

  Head, EU / RoW / Regulatory Affairs Pharmaceuticals Division, PDR

• Sponsor organisation

  F. Hoffmann-La Roche Ltd

• Eudract number

  2020-005231-78

• Clinicaltrials.gov Identifier

  NCT04770896

• Research summary

  Hepatocellular carcinoma (HCC), a particular type of liver cancer is the sixth most common cancer globally and liver cancer is the third most deadly cancer after lung and stomach cancer (Bray et al 2018) with 5-year survival rates ranging between 3-17% (Siegel 2019). There are over 840,000 new cases diagnosed each year worldwide. HCC is difficult to treat and often diagnosed at a late stage due to the late appearance of symptoms.
  Standard of care for first line treatment has been a therapy called “a tyrosine kinase inhibitor”, sorafenib or lenvatinib and more recently the combination of atezolizumab plus bevacizumab, which is becoming the SOC for first-line treatment in patients with advanced HCC.
  Atezolizumab is an antibody (a protein similar to the ones produced by the body's immune system) that blocks the programmed death-ligand 1 (PD-L1) pathway. The PD-L1 pathway is involved in regulating the body's natural immune response, but tumours can take advantage of this regulation to partially resist or evade the immune system. By blocking the PD-L1 pathway, atezolizumab may help your immune system stop or reverse the growth of tumours.
  This Global Phase 3 study is testing if continuing treatment with atezolizumab (which had been used in the first line treatment for HCC) and combining it with either lenvatinib or sorafenib, works better than treating it with a tyrosine kinase inhibitor alone in people with HCC, who progressed after first-line therapy with atezolizumab plus bevacizumab.
  Approximately 554 Patients will be enrolled globally and continue to receive the study treatment for as long as they receive benefit. They will continue to be followed up every 3 months thereafter for as long as they agree to it. The study length is expected to be around 42 months.
  8 UK sites will participate in this study sponsored by F. Hoffmann-La Roche.

• REC name

  HSC REC A

• REC reference

  21/NI/0032

• Date of REC Opinion

  8 Apr 2021

• REC opinion

  Further Information Favourable Opinion