Atezolizumab + Lenvatinib/Sorafenib for Liver Cancer
(IMbrave251 Trial)

Recruiting in Palo Alto (17 mi)

+219 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Hoffmann-La Roche

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is a Phase III, open-label, multicenter, randomized, two-arm study designed to evaluate the efficacy and safety of atezolizumab plus either lenvatinib or sorafenib versus lenvatinib or sorafenib alone in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have progressed on prior systemic treatment with atezolizumab plus bevacizumab combination.

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

This trial is for adults with advanced liver cancer who've seen their disease progress after treatment with Atezolizumab and Bevacizumab. They should have a good performance status, meaning they're able to carry out daily activities with minimal assistance. Patients must not have certain other cancers or brain metastases that are causing symptoms or require treatment.

Inclusion Criteria

My liver function is classified as Child-Pugh A.

I have a cancer lesion that can be measured and has either not been treated or has grown after treatment.

I am fully active or restricted in physically strenuous activity but can do light work.

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Exclusion Criteria

My liver cancer is a specific type: fibrolamellar, sarcomatoid, or mixed with bile duct cancer.

I have had cancer spread to the lining of my brain and spinal cord.

I have brain metastases that are untreated or getting worse.

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Treatment Details

Interventions

Atezolizumab (Monoclonal Antibodies)
Lenvatinib (Tyrosine Kinase Inhibitor)
Sorafenib (Tyrosine Kinase Inhibitor)

Trial OverviewThe study compares the effectiveness of adding Atezolizumab to Lenvatinib or Sorafenib versus using Lenvatinib or Sorafenib alone in patients whose liver cancer has worsened despite previous treatments. It's a Phase III trial, which means it's testing a treatment already shown to be safe and effective in earlier phases.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Atezolizumab + Lenvatinib or SorafenibExperimental Treatment3 Interventions

Participants will receive atezolizumab plus lenvatinib or sorafenib. Treatment will continue until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Group II: Lenvatinib or SorafenibActive Control2 Interventions

Participants will receive lenvatinib or sorafenib. Treatment will continue until unacceptable toxicity or loss of clinical benefit as determined by the investigator.