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Immunotherapy for Liver Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up randomization up to approximately 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies new treatments for people with resectable liver cancer. It is open-label, multicenter & flexible to add or remove treatments as needed.

Who is the study for?

This trial is for adults with Hepatocellular Carcinoma (HCC) that can be surgically removed. They must have a confirmed diagnosis, measurable disease, good performance status, and proper liver function. No prior treatments for HCC are allowed, and they should not have any serious co-infections or conditions that could complicate surgery or treatment.

What is being tested?

The study tests combinations of immunotherapy drugs (Tobemstomig, Tiragolumab, Atezolizumab, Bevacizumab) given before surgery to remove the cancer. It's flexible to adapt by adding new treatments or stopping ones based on results and safety.

What are the potential side effects?

Potential side effects may include immune-related reactions affecting organs, infusion reactions from the drugs being administered into the bloodstream, increased risk of infections due to immune system suppression, bleeding issues related to blood vessel growth inhibition by Bevacizumab.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ randomization up to approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~randomization up to approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization up to approximately 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Major Pathologic Response (MPR) Rate

Secondary study objectives

Event-Free Survival (EFS)

OS Rate at 24 Months

OS Rate at 36 Months

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Tobe + BevExperimental Treatment2 Interventions

Participants in the Tobemstomig + Bev arm will receive up to three cycles of treatment until surgery or unacceptable toxicity, whichever occurs first.

Group II: Atezo + Bev +TiraExperimental Treatment3 Interventions

Participants in the atezolizumab plus bevacizumab plus tiragolumab (Atezo + Bev +Tira) arm will receive up to three cycles of treatment until surgery or unacceptable toxicity, whichever occurs first.

Group III: Atezo + BevExperimental Treatment2 Interventions

Participants in the atezolizumab plus bevacizumab (Atezo + Bev) arm will receive up to three cycles of treatment until surgery or unacceptable toxicity, whichever occurs first.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2016

Completed Phase 3

~5860

Bevacizumab

2013

Completed Phase 4

~5540