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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHoffmann-La Roche

About this trial

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.

Eligibility criteria

Qualifiers

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 7 days prior to randomization

Locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC) with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of

Liver Diseases criteria in cirrhotic patients

Child-Pugh class A within 7 days prior to randomization

Disqualifiers

Prior treatment with CD137 agonists or immune checkpoint blockade therapies or inhibitors targeting HIF2a

Treatment with investigational therapy within 28 days prior to initiation of study

Treatment with locoregional therapy to liver within 28 days prior to initiation of study, or non-recovery from side effects of any such procedure

Untreated or incompletely treated esophageal and/or gastric varices with bleeding or at high risk for bleeding

Trial design

Treatments tested in this trial

  • Atezolizumab
  • Bevacizumab 15 mg/kg
  • Tiragolumab
  • Tocilizumab
  • TPST-1120
  • Tobemstomig 2100 mg
  • Bevacizumab 10 mg/kg
  • Tobemstomig 600 mg
  • Tobemstomig 1200 mg
  • ADG126
  • IO-108 1800 mg
  • NKT2152
  • IO-108 1200 mg

Treatment groups

518 Participants
are divided into 11 treatment groups

11

Treatment groups

See each treatment group below.

Sponsors and collaborators

Hoffmann-La Roche

Lead sponsor

Adagene Inc

Collaborator

Tempest Therapeutics

Collaborator

NiKang Therapeutics, Inc.

Collaborator

Immune-Onc Therapeutics

Collaborator