Artemide-HCC01
Research type
Research Study
Full title
A Phase III, Randomised, Open-label, Sponsor-blinded, Multicentre Study of Rilvegostomig in Combination with Bevacizumab with or without Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma (ARTEMIDE-HCC01)
IRAS ID
1013298
Contact name
Juliet Wou
Contact email
Sponsor organisation
AstraZeneca AB
Clinicaltrials.gov Identifier
Research summary
Globally, liver cancer is the sixth most diagnosed cancer and third most common cause of cancer-related deaths. HCC is the most common type of liver cancer, accounting for >80% of cases (Rumgay et al 2022), and usually diagnosed at an advanced stage. Despite the advances in treatment options, a significant proportion of patients with advanced HCC continues to have poor life expectancy and a substantial number of patients show inadequate response to existing SoCs (Montironi et al 2023). This underscores the critical reality that advanced HCC remains an incurable disease with significant unmet medical needs.
Historical studies have indicated the importance of combination of anti-PD-1 and anti-VEGF, the importance of anti-CTLA-4 and the potential value of anti-TIGIT. The proposed Ph III ARTEMIDE HCC01 study is designed to evaluate a CPI based combination with 4 MoAs to provide
improved clinical efficacy with a manageable safety profile.
This is a Phase III randomised, open label, sponsor blinded, 3 arm, multicentre, global study assessing the efficacy and safety of rilvegostomig in combination with bevacizumab with or without tremelimumab compared to atezolizumab in combination with bevacizumab. This study will be conducted in participants with locally advanced or metastatic and/or unresectable HCC who are not amenable to curative therapy or locoregional therapy and have not received prior systemic therapy for intermediate, advanced, or metastatic HCC. Experienced on combination use of Immunotherapy, highvolume hepatology/oncology sites with untreated 1L HCC patients, who can provide tumor sample for PD-L1 will be preferred to involve in this study.
Participants enrolled in the study may continue to receive the study interventions, at the Investigator’s discretion, until disease progression defined by RECIST 1.1, unacceptable toxicity or any other intervention discontinuation criterion are met. Close safety monitoring and imaging scans will be conducted accordingREC name
London - Fulham Research Ethics Committee
REC reference
26/LO/0167
Date of REC Opinion
17 Mar 2026
REC opinion
Further Information Favourable Opinion