A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating Multiple Immunotherapy Combinations in Advanced Liver Cancers (Morpheus-Liver)

What this Trial Is About

Researchers are evaluating the safety and effectiveness of multiple immunotherapy-based drug combinations in patients with advanced liver cancers, specifically targeting those with locally advanced or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy. This Phase Ib/II, open-label, multicenter, randomized umbrella study is designed to adapt by adding or closing treatment arms based on clinical activity or toxicity, and to include new participant groups as needed. Participants are randomly assigned to different treatment groups in Stage 1, including combinations of drugs such as atezolizumab, bevacizumab, tiragolumab, tocilizumab, TPST-1120, tobemstomig, ADG126, IO-108, and NKT2152. These drugs are administered through intravenous infusion or oral intake on specific schedules, mostly every 21 or 28 days. If participants lose clinical benefit or experience unacceptable side effects during Stage 1, they may be eligible for Stage 2 treatment with different drug combinations introduced through protocol amendments. During the study, participants will be closely monitored using radiographic and biochemical assessments, local biopsies when available, and clinical evaluations to determine toxicity and treatment effectiveness. Researchers will measure outcomes such as objective response rate, progression-free survival, overall survival, duration of response, disease control, and the occurrence of adverse events over a period of up to approximately 7 to 9 years. The study includes ongoing safety monitoring and long-term follow-up to assess the treatments' impact on liver cancer.

A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver)