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Atezolizumab + Bevacizumab for Liver Cancer (IMbrave050 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
Child-Pugh Class A status
For patients with resected HCC, availability of a representative baseline tumor tissue sample
Must not have
History of GI fistula, GI perforation, or intra-abdominal abscess
Significant vascular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 24 and 36 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will test a new treatment for liver cancer that has been removed or destroyed. The new treatment is a combination of two drugs, and will be compared to active surveillance.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Atezolizumab may cause immune-related reactions like rash or inflammation in organs; Bevacizumab might increase bleeding risk, cause high blood pressure, and slow wound healing. Both drugs could potentially lead to fatigue and affect how your body fights infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver function is mildly affected.
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I can provide a sample of my tumor that was removed.
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My cancer has not spread beyond my liver, confirmed by scans.
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I agree to either not have sex or use a condom, and not donate sperm.
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I am fully active or can carry out light work.
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My cancer has not spread beyond my liver or into major blood vessels.
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My liver cancer was fully removed or treated with RFA/MVA.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a GI fistula, perforation, or an abscess inside my abdomen.
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I have a serious blood vessel condition.
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My liver cancer is of a specific type (fibrolamellar, sarcomatoid, or mixed).
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I have both hepatitis B and D.
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I had a core biopsy within 3 days before starting my treatment cycle.
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I have a serious wound that is not healing.
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I've had more than one round of TACE after surgery.
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I am currently taking or have recently taken drugs that affect my immune system.
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I have a significant buildup of fluid in my abdomen.
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I haven't had major heart problems or unstable heart conditions in the last 3 months.
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I am currently taking aspirin or blood thinners.
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I have had a severe hypertension crisis or brain issues due to high blood pressure.
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I have not had major surgery in the last four weeks.
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I have received treatments for liver cancer before surgery or ablation.
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I am not pregnant or breastfeeding and do not plan to become pregnant soon.
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I have a history of certain lung conditions or signs of lung inflammation on a recent scan.
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I have had episodes of brain confusion due to liver problems.
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I have or had an autoimmune disease or immune deficiency.
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My cancer has come back or spread from its original site.
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I have active tuberculosis.
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My high blood pressure is not well controlled.
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I take NSAIDs every day for a chronic condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 24 and 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 and 36 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
Recurrence-Free Survival (RFS), as Determined by IRF
Secondary study objectives
Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
OS Rate at 24 and 36 Months
Overall Survival (OS)
+5 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
9%
Neutrophil count decreased
9%
Rash
8%
Dysgeusia
8%
Headache
8%
Paraesthesia
7%
Pain in extremity
7%
Mucosal inflammation
7%
Back pain
7%
Peripheral sensory neuropathy
7%
Insomnia
6%
Febrile neutropenia
6%
Pneumonia
6%
Lacrimation increased
6%
Abdominal pain
6%
Dry skin
6%
Dizziness
5%
Malaise
5%
Urinary tract infection
5%
Weight decreased
5%
Haemoptysis
5%
Nail disorder
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
4%
Productive cough
3%
Upper respiratory tract infection
3%
Pruritus
2%
Influenza like illness
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
1%
Syncope
1%
Dehydration
1%
Atrial fibrillation
1%
Lower respiratory tract infection
1%
Lung infection
1%
Respiratory tract infection
1%
Acute kidney injury
1%
Chronic obstructive pulmonary disease
1%
Pleural effusion
1%
Depression
1%
Musculoskeletal chest pain
100%
80%
60%
40%
20%
0%
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: 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5540
Atezolizumab
2016
Completed Phase 3
~5860

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,459 Previous Clinical Trials
1,096,376 Total Patients Enrolled
7 Trials studying Hepatocellular Carcinoma
5,338 Patients Enrolled for Hepatocellular Carcinoma
Clinical TrialsStudy DirectorHoffmann-La Roche
2,228 Previous Clinical Trials
895,322 Total Patients Enrolled
4 Trials studying Hepatocellular Carcinoma
5,260 Patients Enrolled for Hepatocellular Carcinoma

Media Library

Atezolizumab Clinical Trial Eligibility Overview. Trial Name: NCT04102098 — Phase 3
Hepatocellular Carcinoma Research Study Groups: Arm B (active surveillance), Arm A (atezolizumab plus bevacizumab)
Hepatocellular Carcinoma Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT04102098 — Phase 3
Atezolizumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT04102098 — Phase 3
~113 spots leftby Dec 2025
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