NCT05908786

A Study Evaluating The Efficacy and Safety of Neoadjuvant Immunotherapy Combinations in Patients With Surgically Resectable Hepatocellular Carcinoma

A Phase Ib/II, Open-Label, Multicenter, Randomized Platform Study Evaluating The Efficacy and Safety of Neoadjuvant Immunotherapy Combinations in Patients With Surgically Resectable Hepatocellular Carcinoma (MORPHEUS-NEO HCC)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• 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 platform study to evaluate neoadjuvant immunotherapy combinations in participants with resectable HCC. The study is designed with the flexibility to open new treatment arms as new agents become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the participant population.

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
DRUG	Atezolizumab	Atezolizumab will be administered at a dose of 1200 mg by IV infusion on Day 1.
DRUG	Bevacizumab	Bevacizumab will be administered at a dose of 15 mg/kg by IV infusion on Day 1.
DRUG	Tiragolumab	Tiragolumab will be administered at a dose of 600 mg by IV infusion on Day 1.
DRUG	Tobemstomig	Tobemstomig will be administered at a dose of 600 mg by IV infusion on Day 1

Timeline

• Start date: 2023-12-05
• Primary completion: 2025-08-27
• Completion: 2025-11-13
• First posted: 2023-06-18
• Last updated: 2025-12-11

Locations

30 sites across 9 countries: United States, Austria, France, Germany, New Zealand, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study