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Monoclonal Antibodies

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

Phase 3

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

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

Must have

At least one measurable (per RECIST v1.1) target lesion that has not been previously treated with local therapy or, if the target lesion is within the field of previous local therapy, has subsequently progressed in accordance with RECIST v1.1

Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 within 7 days prior to randomization

Must not have

Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC

History of leptomeningeal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up randomization to first deterioration maintained for two consecutive assessments, or one assessment followed by death from any cause wthin 3 weeks or 6 weeks (approximately 42 months)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing if adding atezolizumab to lenvatinib or sorafenib improves treatment of liver cancer that has progressed despite treatment with atezolizumab and bevacizumab.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Atezolizumab can cause immune-related side effects like rash, hepatitis, colitis (inflammation of the colon), hormone gland problems, and infusion reactions. Lenvatinib and Sorafenib may cause high blood pressure, fatigue, diarrhea, appetite loss, weight loss, bleeding complications among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Select...

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

Select...

My liver cancer is advanced, can't be removed by surgery, and is confirmed by tests or clinical criteria.

Select...

My liver cancer progressed after treatment with atezolizumab and bevacizumab.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have brain metastases that are untreated or getting worse.

Select...

I've had liver-related brain issues in the last 6 months that didn't improve with treatment within 3 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ randomization to first deterioration maintained for two consecutive assessments, or one assessment followed by death from any cause wthin 3 weeks or 6 weeks (approximately 42 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~randomization to first deterioration maintained for two consecutive assessments, or one assessment followed by death from any cause wthin 3 weeks or 6 weeks (approximately 42 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization to first deterioration maintained for two consecutive assessments, or one assessment followed by death from any cause wthin 3 weeks or 6 weeks (approximately 42 months) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall Survival (OS)

Secondary study objectives

Confirmed Objective Response Rate (ORR)

Duration of Response (DOR)

Progression Free Survival (PFS)

+2 more

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227

36%

Fatigue

35%

Alopecia

24%

Diarrhoea

23%

Nausea

23%

Decreased appetite

22%

Anaemia

20%

Asthenia

19%

Cough

19%

Dyspnoea

16%

Myalgia

15%

Neutropenia

14%

Constipation

14%

Oedema peripheral

12%

Pyrexia

11%

Stomatitis

11%

Vomiting

11%

Neuropathy peripheral

10%

Arthralgia

Neutrophil count decreased

Rash

Headache

Dysgeusia

Paraesthesia

Pain in extremity

Mucosal inflammation

Back pain

Peripheral sensory neuropathy

Insomnia

Pneumonia

Febrile neutropenia

Lacrimation increased

Abdominal pain

Dry skin

Dizziness

Malaise

Urinary tract infection

Weight decreased

Haemoptysis

Nail disorder

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Productive cough

Upper respiratory tract infection

Pruritus

Influenza like illness

Alanine aminotransferase increased

Aspartate aminotransferase increased

Syncope

Dehydration

Atrial fibrillation

Lower respiratory tract infection

Lung infection

Respiratory tract infection

Acute kidney injury

Chronic obstructive pulmonary disease

Pleural effusion

Depression

Musculoskeletal chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2016

Completed Phase 3

~5860

Lenvatinib

2017

Completed Phase 4

~2040