NCT04524871

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

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)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 518 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Liver Cancers

Interventions

Type	Name	Description
DRUG	Atezolizumab	Atezolizumab will be administered at a dose of 1200 mg by IV on Day 1 of each 21 day cycle.
DRUG	Bevacizumab 15 mg/kg	Bevacizumab will be administered at a dose of 15 mg/kg by IV infusion on Day 1 of each 21 day cycle.
DRUG	Tiragolumab	Tiragolumab will be administered at a dose of 600 mg by IV infusion on Day 1 of each 21 day cycle.
DRUG	Tocilizumab	Tocilizumab will be administered at a dose of 8 mg/kg by IV infusion on Day 1 of each 21 day cycle.
DRUG	TPST-1120	TPST-1120 will be administered at a dose of 1200 mg by mouth on Days 1-21 of each 21 day cycle.
DRUG	Tobemstomig 2100 mg	Tobemstomig will be administered at a dose of 2100 mg by IV infusion on Days 1 and 15 of each 28 day cycle.
DRUG	Bevacizumab 10 mg/kg	Bevacizumab will be administered at a dose of 10 mg/kg by IV infusion on Days 1 and 15 of each 28 day cycle.
DRUG	Tobemstomig 600 mg	Tobemstomig will be administered at a dose of 600 mg by IV infusion on Day 1 of each 21 day cycle.
DRUG	Tobemstomig 1200 mg	Tobemstomig will be administered at a dose of 1200 mg every 3 weeks.
DRUG	ADG126	ADG126 will be administered at a dose of 6 mg/kg by IV infusion on Day 1 of every other cycle (cycle length = 21 days).
DRUG	IO-108 1800 mg	IO-108 will be administered at a dose 1800 mg by IV infusion on Day 1 of each 21 day cycle.
DRUG	NKT2152	NKT2152 will be administered by mouth.
DRUG	IO-108 1200 mg	IO-108 will be administered at a dose 1200 mg by IV infusion on Day 1 of each 21 day cycle.

Timeline

• Start date: 2020-11-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2020-08-24
• Last updated: 2026-03-27

Locations

33 sites across 7 countries: United States, China, France, Israel, New Zealand, South Korea, Taiwan

Regulatory

• FDA-regulated drug study