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

ACTIVE_NOT_RECRUITINGPHASE2

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

An Exploratory Evaluation of the Evolution of the Tumor Immune Microenvironment in Hepatocellular Carcinoma and Non-Small Cell Lung Cancer With Liver Metastases Treated With Atezolizumab and Bevacizumab (INTEGRATE)

NCT04563338•University Health Network, Toronto

View on ClinicalTrials.gov

Summary

This study is being done to look at how effective the drug, atezolizumab, with or without the drug bevacizumab, is for people with inoperable liver cancer or non-small lung cancer that has spread to the liver. This will be done by looking at the duration of time from starting the study drug(s) until the cancer worsens in study participants. This study will collect blood and tumor tissue samples from participants to look at changes to their tumor(s) before and after receiving atezolizumab and/or bevacizumab.

Detailed Description

Participants with liver cancer will be assigned to Arm A and receive atezolizumab and bevacizumab. Participants with non-small cell lung cancer will be randomized into one of the following arms: * Arm B: Atezolizumab and bevacizumab * Arm C: Atezolizumab alone Participants randomized to Arm C whose disease worsens may be able to cross over to Arm B and receive atezolizumab and bevacizumab together.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Be willing and able to provide written informed consent.
•Be ≥ 18 years of age on day of signing informed consent.
•Have histologically or cytologically confirmed diagnosis of inoperable hepatocellular carcinoma (HCC) or non-squamous non-small cell lung cancer (NSCLC) with liver metastases with at least one measurable lesion.
•NSCLC patients who were previously treated with chemotherapy or treatment naïve patients with a programmed death ligand-1 (PD-L1) tumor proportion score ≥50% or tumor cell score 3/immune cell score 3 are included.
•NSCLC patients must be epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild type.
•HCC patients may be treatment naïve or treated with prior tyrosine kinase inhibitor(s).
•Have a current liver function meeting Child Pugh Class A (5-6 points) in patients with HCC, with no encephalopathy or ascites.
•Be willing to provide tumor tissue from a core biopsy of a tumor lesion (archival not acceptable). The subject must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy. In addition, the subject must be willing to give blood for correlative studies, and have no contraindications to this.
•Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
•Have recovered (to ≤ grade 1) from prior toxicities related to previous treatments at the time of study enrollment, with the exception of alopecia or skin depigmentation.
+27 more criteria

Exclusion Criteria

•Has received stereotactic radiotherapy within 4 weeks of trial commencement. For chemotherapy, tyrosine kinase inhibitors and palliative-dose radiotherapy, a 2 week washout is required.
•Is currently participating and receiving experimental treatment as part of a clinical trial, or has participated in a study of an immune checkpoint inhibitor and received study therapy, or used an investigational device within 4 weeks of the first dose of treatment.
•Inadequately controlled hypertension (defined as systolic blood pressure \[BP\] \> 150 mmHg and/or diastolic blood pressure \> 100 mmHg), based on an average of ≥ 3 BP readings on ≥ 2 sessions. Anti-hypertensive therapy to achieve these parameters is allowed.
•History of hypertensive crises or hypertensive encephalopathy
•Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident within 3 months prior to initiation of study treatment), unstable arrhythmia, or unstable angina
•Significant vascular disease (eg. aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to randomization
•History of Grade ≥ 4 venous thromboembolism.
•History of Grade ≥ 2 hemoptysis (defined as ≥ 2.5 mL of bright red blood per episode) within 1 month prior to screening for HCC and within 3 months for NSCLC.
•History or evidence of bleeding diathesis or significant coagulopathy at risk of bleeding (ie. In the absence of therapeutic anticoagulation)
•Surgical procedure (including open biopsy, surgical resection, wound revision, or any other major surgery involving entry into a body cavity) or significant traumatic injury within 28 days prior to initiation of study treatment and wounds are fully healed, or anticipation of need for major surgical procedure during the course of the study.
+6 more criteria

Locations (1)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Key Dates

Start Date

June 4, 2021

Primary Completion Date

June 25, 2024

Completion Date

August 31, 2026

Last Updated

March 5, 2026

Enrollment

ESTIMATED participants

Conditions

Hepatocellular CarcinomaNon-small Cell Lung Cancer MetastaticLiver Metastases

Interventions

Atezolizumab

DRUG

Bevacizumab

DRUG

Early Detection of Liver Cancer by QUS

NCT06345508

Hepatocellular CarcinomaLiver Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Early Detection of Liver Cancer by QUS

Testing the Addition of an Anti-cancer Drug, Sapanisertib, to the Usual Chemotherapy Treatment (Cabozantinib) in Metastatic Liver Cell Cancer With a Change in Genes for the Protein β-Catenin, The SAPHIRE Trial

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Nivolumab, Fluorouracil, and Interferon Alpha 2B for the Treatment of Unresectable Fibrolamellar Cancer

Ultra-high Dose Radiation for Liver Metastasis Using MR-guided TReatment With Stereotactic Ablative Single-fraction