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

Study acronym: MORPHEUS-LIVER
StatusActive, Not Recruiting
PhasePhase 1/2
Started2020-11-01
View on ClinicalTrials.gov ↗
This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with advanced liver cancers. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, modify the participant population, or introduce additional cohorts of participants with other types of advanced primary liver cancer. Cohort 1 will enroll participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy for their disease. Eligible participants will initially be randomly assigned to one of several treatment arms (Stage 1). Participants who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to receive treatment with a different treatment combination (Stage 2). When a Stage 2 treatment combination is available, this will be introduced by amending the protocol.

Amendment history 3 changes detected by DataLookout

2026-09-04
notable
Enrollment closed, study ongoing
2026-04-24
minor
Primary completion moved earlier: 2027-12-31 → 2027-07-30
2026-04-24
minor
Completion moved earlier: 2027-12-31 → 2027-09-30
Trial Details
NCT Number NCT04524871
Lead Sponsor Hoffmann-La Roche
Collaborators: Adagene Inc, Tempest Therapeutics, NiKang Therapeutics, Inc., Immune-Onc Therapeutics
Conditions Advanced Liver Cancers
Enrollment 518 participants
Start Date 2020-11-01
Primary Completion 2027-07-30 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-03