Phase IbII Study of Multiple Immunotherapy Combinations for Advanced Liver Cancer Morpheus-Liver

What this Trial Is About

Researchers are conducting a Phase IbII, open-label, multicenter, randomized umbrella study to evaluate multiple immunotherapy-based treatment combinations in participants with advanced liver cancers. This study is designed to be flexible, allowing new treatment arms to open as new therapies become available and to close those with minimal activity or unacceptable toxicity. The initial focus is on participants with locally advanced or metastatic hepatocellular carcinoma HCC who have not received prior systemic therapy for their disease. Participants are randomly assigned to one of several treatment arms, receiving combinations such as atezolizumab plus bevacizumab, with additional drugs like tiragolumab, tocilizumab, TPST-1120, Tobemstomig, ADG126, IO-108, or NKT2152, depending on the arm. Treatments involve intravenous infusions or oral medications administered in cycles of 21 or 28 days, continuing until unacceptable toxicity or loss of clinical benefit occurs. Participants experiencing loss of benefit or toxicity during the initial stage may become eligible for a second stage involving different treatment combinations introduced via protocol amendments. Throughout the study, participants undergo regular assessments including radiographic and biochemical evaluations, biopsy when possible, and clinical status monitoring. The primary outcome is the objective response rate from randomization until disease progression or loss of clinical benefit, observed for up to 7 to 9 years. Secondary outcomes include progression-free survival, overall survival, duration of response, disease control, and the frequency of adverse events over the study period. The trial is sponsored by Hoffmann-La Roche and involves long-term monitoring until study completion in 2027.

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