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Monoclonal Antibodies

Atezolizumab + Bevacizumab for Liver Cancer (AB7 Trial)

Phase 2

Waitlist Available

Led By Kristen Spencer, DO, MPH

Research Sponsored by Kristen Spencer

Eligibility Criteria Checklist

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

Must have

At least 1 untreated measurable lesion according to RECIST 1.1

Locally advanced, metastatic, or unresectable hepatocellular carcinoma that has not received prior systemic therapy

Must not have

Patients with clinically meaningful ascites

Uncontrolled pleural effusion or pericardial effusion requiring frequent drainage procedures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the safety of combining atezolizumab and bevacizumab in patients with advanced liver cancer who have not received prior systemic therapy.

Who is the study for?

This trial is for adults with advanced liver cancer (Hepatocellular Carcinoma) who haven't had systemic therapy before. They should have a specific level of liver dysfunction (Child-Pugh B7 or B8), be able to perform daily activities with little help, and agree to use contraception. People can't join if they're on high-dose steroids, have certain heart or lung conditions, uncontrolled other diseases, or are expected to need treatment for another cancer within two years.

What is being tested?

The study tests the safety of combining Atezolizumab and Bevacizumab in patients with advanced liver cancer. It's a single group trial where all participants receive both drugs without being compared to another treatment or placebo.

What are the potential side effects?

Possible side effects include immune-related reactions that may affect organs, infusion-related reactions from the drug entering the body, increased risk of infections due to immune system suppression, bleeding issues because Bevacizumab affects blood vessels, and potential hypertension.

Eligibility Criteria

Inclusion Criteria

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

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I have at least one cancer spot that hasn't been treated yet.

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My liver cancer is advanced or inoperable and I haven't had systemic therapy.

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My cancer's genetic test was done on stored or newly taken tissue.

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I am fully active or can carry out light work.

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My liver is not working well but it's not the worst case.

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I am 18 years old or older.

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I agree to use contraception or remain abstinent.

Exclusion Criteria

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

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I have significant fluid buildup in my abdomen.

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I frequently need procedures to remove fluid from around my lungs or heart.

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I have active tuberculosis.

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My liver cancer is of a specific rare type.

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I have high calcium levels in my blood that are causing symptoms.

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I have previously received immunotherapy.

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I have significant confusion or memory problems.

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I have pain from my cancer that isn't relieved by medication.

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I have had lung conditions like pulmonary fibrosis or pneumonitis.

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I have had a solid organ or bone marrow transplant in the past.

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I am taking high doses of steroids or other drugs for an autoimmune disease.

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I have untreated brain or spinal cord disease.

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I have not had a serious infection in the last 2 weeks.

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I have had kidney disorders involving protein in the urine or inflammation.

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My high blood pressure is not controlled, even with maximum treatment.

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I am currently taking medication that weakens my immune system.

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I have previously been treated with specific immune therapies.

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I have had treatment for liver cancer before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Frequency and severity of toxicities

Secondary study objectives

Disease control rate (DCR)

Duration of response (DOR)

Median overall survival (OS)

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Study TreatmentExperimental Treatment2 Interventions

Atezolizumab 1,200 mg IV and bevacizumab 15 mg/kg IV every 3 weeks (on day 1 of each 21-day cycle). Treatment will continue until disease progression or development of unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2016

Completed Phase 3

~5860

Bevacizumab

2013

Completed Phase 4

~5540