Atezolizumab + Bevacizumab for Liver Cancer
(IMbrave050 Trial)

Recruiting in Palo Alto (17 mi)

+228 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Hoffmann-La Roche

Stay on Your Current Meds

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This study will evaluate the efficacy and safety of adjuvant therapy with atezolizumab plus bevacizumab compared with active surveillance in participants with completely resected or ablated hepatocellular carcinoma (HCC) who are at high risk for disease recurrence.

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

This trial is for adults who've had a specific liver cancer (HCC) surgically removed or treated with ablation, and are at high risk of the cancer coming back. They should be fully recovered from treatment, have no major liver vessel invasion or cancer spread outside the liver, and have good liver function (Child-Pugh Class A). Participants need to be in decent health overall (ECOG 0-1), able to use birth control if necessary, and not pregnant.

Inclusion Criteria

I fully recovered from a liver cancer treatment procedure within the last 4 weeks.

My liver function is mildly affected.

I have fully recovered from surgery or ablation within the last 4 weeks.

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Exclusion Criteria

I have had a GI fistula, perforation, or an abscess inside my abdomen.

I have a serious blood vessel condition.

My liver cancer is of a specific type (fibrolamellar, sarcomatoid, or mixed).

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Treatment Details

Interventions

Atezolizumab (Monoclonal Antibodies)
Bevacizumab (Monoclonal Antibodies)

Trial OverviewThe study tests whether adding Atezolizumab plus Bevacizumab after surgery or ablation can prevent HCC from returning compared to just watching patients closely without additional drug treatment. Patients will either receive the drug combo or enter active surveillance where their condition is monitored regularly.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A (atezolizumab plus bevacizumab)Experimental Treatment2 Interventions

Participants will receive Atezolizumab + Bevacizumab until disease recurrence or unacceptable toxicity.

Group II: Arm B (active surveillance)Active Control1 Intervention

Active surveillance of participants.