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

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

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.

Sponsors & Collaborators

• Adagene Inc

  collaborator INDUSTRY

• Tempest Therapeutics

  collaborator INDUSTRY

• NiKang Therapeutics, Inc.

  collaborator INDUSTRY

• Immune-Onc Therapeutics

  collaborator INDUSTRY

• Hoffmann-La Roche

  lead INDUSTRY

Principal Investigators

• Clinical Trials · Hoffmann-La Roche

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-01

Primary Completion

2027-07-30

Completion

2027-09-30

FDA Drug

Yes

Countries

• United States
• China
• France
• Israel
• New Zealand
• South Korea
• Taiwan

Study Locations