Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Costa Mesa, California and other locations
Dates
study started
completion around

Description

Summary

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.

Official Title

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver)

Keywords

Advanced Liver Cancers, Liver Neoplasms, Bevacizumab, Atezolizumab, Bevacizumab 15 mg/kg, Tiragolumab, Tocilizumab, TPST-1120, Tobemstomig 2100 mg, Bevacizumab 10 mg/kg, Tobemstomig 600 mg, Tobemstomig 1200 mg, ADG126, NKT2152

Eligibility

Locations

  • UC Irvine Medical Center accepting new patients
    Costa Mesa California 92627 United States
  • UC Irvine Medical Center in progress, not accepting new patients
    Orange California 92868 United States
  • City of Hope accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT04524871
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 518 study participants
Last Updated