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Checkpoint Inhibitor

Atezolizumab + Multi-Kinase Inhibitor for Liver Cancer

Phase 2

Recruiting

Led By Wen Wee Ma

Research Sponsored by Academic and Community Cancer Research United

Eligibility Criteria Checklist

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

Must have

Serum creatinine =< 2 x ULN or creatinine clearance >= 30 mL/min (calculated using the Cockcroft-Gault formula)

Hepatocellular carcinoma (HCC) confirmed by histological/cytological diagnosis or clinically per the American Association for the Study of Liver Diseases (AASLD) or WASL 2018 criteria

Must not have

Other uncontrolled, significant intercurrent or recent illness including cardiovascular disorders, uncontrolled hypertensions, stroke, myocardial infarction, or other ischemic event =< 3 months prior to randomization, uncontrolled arrythmia, thromboembolic event =< 3 months prior to randomization, active bacterial infection requiring systemic treatment, known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS) related illness, prior allogenic stem cell or solid organ transplantation, uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures, uncontrolled or symptomatic hypercalcemia, uncontrolled tumor-related pain, other malignancy(ies) =< 5 years prior to randomization, pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within at least 5 months after the last dose of study medication, uncontrolled hepatic encephalopathy occurring =< 6 weeks prior to randomization

Known diagnosis of fibrolamellar carcinoma, sarcomatoid carcinoma or mixed hepatocellular cholangiocarcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to first documentation of disease progression (per response evaluation criteria in solid tumors [recist] 1.1) or death, assessed up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether atezolizumab, when given with either cabozantinib or lenvatinib, is more effective in treating liver cancer than either of those drugs given alone.

Who is the study for?

This trial is for adults with advanced liver cancer that's inoperable, locally advanced, or metastatic and have previously been treated. Participants must be able to take oral meds, have a specific performance status (ECOG 0 or 1), and their liver function needs to meet certain criteria. Women of childbearing age must test negative for pregnancy and agree to use contraception.

What is being tested?

The study tests atezolizumab combined with cabozantinib or lenvatinib against just the multi-kinase inhibitors alone. Atezolizumab is an immunotherapy drug while cabozantinib and lenvatinib block enzymes that help tumor cells grow. The goal is to see if combining these treatments works better for treating liver cancer.

What are the potential side effects?

Potential side effects include immune-related reactions like inflammation in various organs, fatigue, digestive issues such as nausea or diarrhea, abnormal blood counts leading to increased infection risk or bleeding problems, possible skin reactions, and potential impact on liver function.

Eligibility Criteria

Inclusion Criteria

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

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My kidney function, measured by creatinine levels, is within the required range.

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My liver cancer diagnosis follows specific medical guidelines.

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My condition cannot be cured with surgery or other treatments.

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I am 18 years old or older.

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My white blood cell count is healthy without needing medication to boost it.

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My liver function is mildly affected.

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I am fully active or have some restrictions but can still care for myself.

Exclusion Criteria

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

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I have been diagnosed with a specific type of liver cancer.

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I have a history of specific lung conditions not caused by known factors.

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I am currently receiving treatment that boosts my immune system.

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I have active tuberculosis.

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I have or had an autoimmune disease or immune deficiency.

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I have previously been treated with immune therapy.

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I have untreated or partially treated varices in my esophagus or stomach that are at high risk of bleeding.

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I am currently taking medication that suppresses my immune system.

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I have received multi-kinase inhibitor treatment for advanced disease.

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My cancer has spread to my brain or its coverings.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to first documentation of disease progression (per response evaluation criteria in solid tumors [recist] 1.1) or death, assessed up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to first documentation of disease progression (per response evaluation criteria in solid tumors [recist] 1.1) or death, assessed up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to first documentation of disease progression (per response evaluation criteria in solid tumors [recist] 1.1) or death, assessed up to 2 years 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)

Progression-free survival (PFS)

Secondary study objectives

Duration of response

Incidence of adverse events (AEs)

Objective response rate (ORR)

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

Febrile neutropenia

Pneumonia

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.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A (atezolizumab, cabozantinib or lenvatinib)Experimental Treatment3 Interventions

Patients receive atezolizumab IV over 30-60 minutes on day 1 and cabozantinib PO QD or lenvatinib PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm B (cabozantinib or lenvatinib)Active Control2 Interventions

Patients receive cabozantinib PO QD or lenvatinib PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2016

Completed Phase 3

~5860

Cabozantinib

2020

Completed Phase 2

~2360