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Monoclonal Antibodies

Atezolizumab + Bevacizumab for Liver and Lung Cancers

Phase 2

Recruiting

Led By Adrian Sacher, MD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

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

Must have

NSCLC patients must be epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild type

Be willing to provide tumor tissue from a core biopsy of a tumor lesion (archival not acceptable)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

Study Summary

This trial is testing how well atezolizumab works with or without bevacizumab in people with liver or lung cancer that has spread to the liver.

Who is the study for?

Adults with inoperable liver cancer or non-small cell lung cancer that has spread to the liver, who have adequate organ function and are not pregnant. NSCLC patients must be EGFR/ALK wild type and HCC patients may have had prior treatments. Participants need a measurable lesion, controlled hepatitis B or C, an ECOG performance status of 0 or 1, and agree to use effective contraception.Check my eligibility

What is being tested?

The trial is testing the effectiveness of Atezolizumab alone or combined with Bevacizumab for treating liver cancer or lung cancer with liver metastases by monitoring how long it takes for participants' cancers to worsen after starting treatment. It also involves analyzing blood and tumor tissue samples before and after administration.See study design

What are the potential side effects?

Potential side effects include immune-related reactions affecting organs, high blood pressure due to Bevacizumab's effect on blood vessels, infusion reactions from both drugs, increased risk of infections, bleeding complications, fatigue, and possible interference with wound healing.

Eligibility Criteria

Inclusion Criteria

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

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My NSCLC does not have mutations in EGFR or ALK genes.

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I agree to provide a fresh sample of my tumor for the study.

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My liver is functioning well despite my liver cancer.

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I am 18 years old or older.

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

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My NSCLC has a high PD-L1 score or I haven't had chemotherapy.

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I have liver cancer or lung cancer with liver spread that can't be removed by surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free survival

Secondary outcome measures

Average duration of response

Overall response rate

Overall survival rate

+1 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%

Neuropathy peripheral

11%

Vomiting

11%

Stomatitis

10%

Arthralgia

Rash

Neutrophil count decreased

Dysgeusia

Paraesthesia

Headache

Peripheral sensory neuropathy

Pain in extremity

Insomnia

Mucosal inflammation

Back pain

Pneumonia

Febrile neutropenia

Abdominal pain

Dry skin

Lacrimation increased

Dizziness

Haemoptysis

Weight decreased

Malaise

Urinary tract infection

Nail disorder

Productive cough

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Pruritus

Upper respiratory tract infection

Alanine aminotransferase increased

Aspartate aminotransferase increased

Influenza like illness

Respiratory tract infection

Musculoskeletal chest pain

Lower respiratory tract infection

Acute kidney injury

Depression

Lung infection

Dehydration

Chronic obstructive pulmonary disease

Atrial fibrillation

Syncope

Pleural effusion

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm C (Lung Cancer)Experimental Treatment1 Intervention

Atezolizumab: 1200 mg, intravenously (IV), every 3 weeks

Group II: Arm B (Lung Cancer)Experimental Treatment2 Interventions

Atezolizumab: 1200 mg, intravenously (IV), every 3 weeks Bevacizumab: 15 mg/kg, intravenously (IV), every 3 weeks

Group III: Arm A (Liver Cancer)Experimental Treatment2 Interventions

Atezolizumab: 1200 mg, intravenously (IV), every 3 weeks Bevacizumab: 15 mg/kg, intravenously (IV), every 3 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

2013

Completed Phase 4

~5280

Atezolizumab

2017

Completed Phase 3

~5860

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,474 Previous Clinical Trials

485,006 Total Patients Enrolled

Hoffmann-La RocheIndustry Sponsor

2,431 Previous Clinical Trials

1,090,032 Total Patients Enrolled

Adrian Sacher, MDPrincipal InvestigatorPrincess Margaret Cancer Centre

Media Library

Liver Metastases Research Study Groups: Arm A (Liver Cancer), Arm B (Lung Cancer), Arm C (Lung Cancer)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Atezolizumab been granted clearance by the FDA?

"The safety of Atezolizumab scored a 2 on our evaluation scale, as Phase 2 trials have yielded evidence that it is safe with no proof yet existing for its efficacy."

Answered by AI

Has Atezolizumab been used in other experiments of a similar nature?

"A current total of 621 clinical trials are actively studying Atezolizumab, 142 in the advanced Stage 3. Across31793 medical sites globally, most notably Taibei Taiwan, these studies are being conducted."

Answered by AI

What conditions are often remedied with Atezolizumab?

"Atezolizumab may be a viable treatment option for those suffering from postoperative or recurrent non-squamous non-small cell lung cancer, as well as the more common form of this malignancy - Non-Small Cell Lung Carcinoma."

Answered by AI

Are there any current opportunities to join this scientific investigation?

"The medical trial is currently enrolling participants, according to information posted on the clinicaltrials.gov website. It was initially published on June 4th 2021 and last updated November 26th 2021."

Answered by AI

What is the upper limit of participants accepted into this trial?

"Affirmative. The data on clinicaltrials.gov establishes that this medical trial is currently recruiting participants, having been initially posted June 4th 2021 and most recently revised November 26th 2021. 36 patients are being sought from one particular facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Exploratory Study of Atezolizumab and Bevacizumab in Hepatocellular Carcinoma and Non-Small Cell Lung Cancer With Liver Metastases (INTEGRATE)

2021. "An Exploratory Study of Atezolizumab and Bevacizumab in Hepatocellular Carcinoma and Non-Small Cell Lung Cancer With Liver Metastases (INTEGRATE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04563338.

All > Liver Cancer > Hepatocellular Carcinoma