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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 24 and 36 months
Awards & highlights
IMbrave050 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.Check my eligibility
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.See study design
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.
IMbrave050 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver function is mildly affected.
Select...
I can provide a sample of my tumor that was removed.
Select...
My cancer has not spread beyond my liver, confirmed by scans.
Select...
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.
Select...
My cancer has not spread beyond my liver or into major blood vessels.
Select...
My liver cancer was fully removed or treated with RFA/MVA.
IMbrave050 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 24 and 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 24 and 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recurrence-Free Survival (RFS), as Determined by IRF
Secondary outcome measures
Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
OS Rate at 24 and 36 Months
Overall Survival (OS)
+8 moreSide effects data
From 2019 Phase 3 trial • 1225 Patients • NCT0200822736%
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%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Pain in extremity
7%
Peripheral sensory neuropathy
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
IMbrave050 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
Atezolizumab
2017
Completed Phase 3
~5860
Bevacizumab
2013
Completed Phase 4
~5280
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,386 Total Patients Enrolled
7 Trials studying Hepatocellular Carcinoma
5,338 Patients Enrolled for Hepatocellular Carcinoma
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
887,834 Total Patients Enrolled
4 Trials studying Hepatocellular Carcinoma
5,260 Patients Enrolled for Hepatocellular Carcinoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I fully recovered from a liver cancer treatment procedure within the last 4 weeks.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).My liver function is mildly affected.I have both hepatitis B and D.I had a core biopsy within 3 days before starting my treatment cycle.I've had more than one round of TACE after surgery.I have fully recovered from surgery or ablation within the last 4 weeks.I am currently taking or have recently taken drugs that affect my immune system.I am at high risk of my liver cancer coming back after surgery or ablation.I have a significant buildup of fluid in my abdomen.I haven't had major heart problems or unstable heart conditions in the last 3 months.I am currently taking aspirin or blood thinners.I can provide a sample of my tumor that was removed.I have had a severe hypertension crisis or brain issues due to high blood pressure.My cancer has not spread beyond my liver, confirmed by scans.I have a serious wound that is not healing.I have not had major surgery in the last four weeks.I agree to either not have sex or use a condom, and not donate sperm.I am fully active or can carry out light work.I have received treatments for liver cancer before surgery or ablation.I am not pregnant or breastfeeding and do not plan to become pregnant soon.I had bleeding from untreated or partially treated varices in my esophagus or stomach in the last 6 months.I have a history of certain lung conditions or signs of lung inflammation on a recent scan.I haven't had cancer other than liver cancer in the last 5 years, except for very low-risk types.I had surgery or ablation for liver cancer within the last 3 months.I have had episodes of brain confusion due to liver problems.My cancer has not spread beyond my liver or into major blood vessels.I have or had an autoimmune disease or immune deficiency.My blood and organs are functioning well.My cancer has come back or spread from its original site.I have active tuberculosis.My high blood pressure is not well controlled.I take NSAIDs every day for a chronic condition.My liver cancer was fully removed or treated with RFA/MVA.I don't have any health issues that would make it unsafe for me to take a new drug.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (active surveillance)
- Group 2: Arm A (atezolizumab plus bevacizumab)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How is Atezolizumab most often utilized by doctors?
"Atezolizumab, while most commonly used to treat non-small cell lung carcinoma, can also be an effective form of treatment for postoperative and recurrent non-squamous non-small cell lung cancer as well as recurrent platinum-sensitive epithelial ovarian cancer."
Answered by AI
What other scientific work has been done on Atezolizumab?
"There are 647 ongoing studies and 153 trials in Phase 3 testing the efficacy of Atezolizumab. Most of these medical trials are being conducted in Taibei, Taiwan; however, there are a total 34170 locations running Atezolizumab studies."
Answered by AI
How many test subjects are included in the data set of this experiment?
"Presently, this study is not looking for new participants. The clinical trial was first posted on December 31st, 2019 and the most recent update to the posting was on August 22nd, 2022. However, there are presently 3508 studies actively recruiting participants with carcinoma hepatocellular and 647 studies for Atezolizumab that are actively recruiting."
Answered by AI
What is the fatality rate of Atezolizumab?
"Atezolizumab has received a score of 3 from our team at Power. This is because Atezolizumab is in Phase 3 clinical trials, meaning that not only does it have some data supporting efficacy, but multiple rounds of data also support safety."
Answered by AI
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