ARTEMIDE-HCC01: A phase 3, randomized, open-label, sponsor-blinded, multicentre, global study of rilvegostomig in combination with bevacizumab with or without tremelimumab as first-line (1L) treatment for unresectable hepatocellular carcinoma (uHCC).

Abstract

TPS612 Background: HCC is the most common liver cancer, accounting for 80–90% globally and often diagnosed late. 1L treatment comprises immunotherapy combinations but outcomes remain poor due to diverse tumor immune-evasive mechanisms. New immunotherapy approaches are needed; combining checkpoint inhibitors (cytotoxic T lymphocyte associated protein 4, programmed cell death-1 [PD-1], and T cell immunoreceptor with Ig and ITIM domains [TIGIT]) with anti-vascular endothelial growth factor is one such approach. Rilvegostomig is a novel bispecific anti-PD-1/anti-TIGIT antibody designed to enhance antitumor activity by overcoming immune-inhibitory signaling. The phase 3 ARTEMIDE-HCC01 study (NCT06921785) will assess efficacy and safety of rilvegostomig plus bevacizumab with/without tremelimumab as 1L treatment for uHCC. Methods: Eligible patients will have confirmed uHCC, no prior systemic therapy, BCLC stage B (not eligible for locoregional therapy)/C, ECOG performance status 0/1, and Child-Pugh class A. This study comprises a safety lead-in and a randomization period. The single-arm safety lead-in period (N=20) will evaluate safety/tolerability of rilvegostomig plus bevacizumab and tremelimumab. In the randomization period, ~1200 patients will be randomized 1:1:1 to receive tremelimumab, rilvegostomig and bevacizumab (arm A), rilvegostomig and bevacizumab (arm B), or atezolizumab and bevacizumab (arm C) until progression/unacceptable toxicity. Randomization will be stratified by macrovascular invasion/extrahepatic spread, liver disease etiology, alpha-fetoprotein level, and programmed death-ligand 1 expression. Primary and secondary endpoints of the safety lead-in period are safety/tolerability and efficacy (objective response rate [ORR]), respectively. The primary endpoint of the randomized period will be overall survival (OS) (arm A vs arm C). Other endpoints include OS (arm B vs arm C), ORR, duration of response, progression-free survival, safety, and quality of life. Enrollment began in May 2025 and is ongoing. Clinical trial information: NCT06921785 .