YO40245 (IMBrave150) - Atezolizumab & Bevacizumab Vs. Sorafenib in HCC
Research type
Research Study
Full 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.
IRAS ID
239811
Contact name
Tim Meyer
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2017-003691-31
Duration of Study in the UK
4 years, 6 months, 22 days
Research summary
Research Summary
Hepatocellular carcinoma (HCC) is the sixth most common cancer worldwide and is the second most cause of death. There are over 700,000 new cases diagnosed each year worldwide.
The purpose of this phase III, randomised, open label study is to find out the safety and efficacy of experimental arm A, atezolizumab in combination with bevacizumab when compared with standard of care arm B, sorafenib in participants with advanced or inoperable HCC.
Atezolizumab is an antibody (a protein similar to the ones produced by your 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 the immune system stop or reverse the growth of tumours. Atezolizumab is approved by the U.S. Food and Drug Administration (FDA) for the treatment of bladder cancer and lung cancer. Atezolizumab will be given in combination with bevacizumab. Bevacizumab is an antibody that slows the growth of new blood vessels and may help the body stop the growth of tumours. In this study, atezolizumab and bevacizumab are experimental drugs, health authorities have not approved either drug for the treatment of HCC.Sorafenib (also known as Nexavar) is a drug that is approved for the standard of care treatment of participants with inoperable HCC and the prognosis of these patients remains poor and associated with significant side effects (toxicities).
The study includes procedures and assessments including: physical examination, medical history, participant questionnaires, vital signs, pregnancy tests (if applicable), tumour assessments, retrieval of tumour sample if available, optional tumour biopsy collection, ECG, recording side effects and medication, survival follow-up, weight, height, performance status, oesophagogastroduodenoscopy (EGD if applicable), blood and urine collection for study-related analysis and optional blood collection for future research analysis.
Preliminary data from a recent small study using atezolizumab with bevacizumab compared with sorafenib in HCC has indicated that the combination of the two drugs was well tolerated with no unexpected adverse events and that the overall response rate to the treatment was improved. Overall the combination of atezolizumab and bevacizumab may be a promising treatment option for patients with HCC, therefore in this study we aim to evaluate the two drugs against sorafenib to help address the ongoing high unmet medical need for patients with HCC.A total of 480 patients with HCC will be enrolled worldwide with 20 anticipated in the UK across 5 sites.
The study is sponsored by F. Hoffmann-La Roche Ltd.
Summary of Results
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Have you enabled sharing of study data with others?: Yes
If yes, describe or provide URLs to how it has been shared: Roche Global Policy on Sharing of Clinical Study Information - https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbaU-2F3svbc0NYS88mnPHAL-2BZhEqeJ01MYRUWqDUX-2FQc39iWYVHfLkznKpn8OPLEQcRb0xiy-2F50361VwI0luXCBBmij51Jlrwtm1yw-2BmvlmSk0JcvmT9MskCnrfxQ8CqgcYGLu1xSOftEy2hIE-2BCYvAAvLKFBdN9hkPx-2Bd6fXimM271I3b_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YJKysOpSE21xYwzeoSby-2FDVSwkIfEyATPq-2BzfQMnKDsJpS-2BReWfiki-2Fd6dE3BhhnwLZ0nFLkuzZviSUn30izdprmKBl-2BkHjNuI9FZyLb2WEaOJ8WwmiroIDYGILjSwuYuOY-2Bepd09lbd4vLnSN4NA8kIiSAx-2Fl3xYcf82nfZY0f9Q-3D-3D&data=05%7C01%7Csurreyborders.rec%40hra.nhs.uk%7Cd021b9092493436ee81208dbda1b0feb%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638343581984511888%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=yx8Yb1hiJjxLKzTAA66nP7uO2Y9IMFHdm94E4zLHyXg%3D&reserved=0
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If no, explain why: Roche does not share samples with third parties; samples are collected in Roche sponsored clinical trials to support research conducted by Roche only. Roche may collaborate with 3rd parties though and samples would be made available to 3rd parties within the context of collaborations covered by collaboration contractual agreements, but samples are not shared with other parties for them to conduct their own research.REC name
London - Surrey Borders Research Ethics Committee
REC reference
18/LO/0683
Date of REC Opinion
14 Jun 2018
REC opinion
Further Information Favourable Opinion