NCT04563338

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)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatocellular Carcinoma
• Non-small Cell Lung Cancer Metastatic
• Liver Metastases

Interventions

Type	Name	Description
DRUG	Atezolizumab	Atezolizumab is a type of drug called a monoclonal antibody. Antibodies are proteins that are naturally found in the blood stream that fight infections. Monoclonal antibodies are a special kind of antibody that is created in a laboratory. These drugs bind (attaches) to specific proteins in the body that may be involved in cancers. Atezolizumab binds to PD-L1 which is a protein involved preventing the body's immune system (defense system against infection and disease) from fighting cancer cells. Blocking PD-L1 is expected to help the immune cells to destroy the cancer cells.
DRUG	Bevacizumab	Bevacizumab is a type of drug called a monoclonal antibody. Antibodies are proteins that are naturally found in the blood stream that fight infections. Monoclonal antibodies are a special kind of antibody that is created in a laboratory. These drugs bind (attaches) to specific proteins in the body that may be involved in cancers. Bevacizumab binds to vascular endothelial growth factor (VEGF) which is a protein involved with the growth of new blood vessels. Blocking VEGF will prevent blood vessels from forming and therefore stopping oxygen and nutrients to be supplied to cancer cells. Without oxygen and nutrients, the cancer cells will die.

Timeline

• Start date: 2021-06-04
• Primary completion: 2024-06-25
• Completion: 2026-08-31
• First posted: 2020-09-24
• Last updated: 2026-03-05

Locations

1 site across 1 country: Canada