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

Sponsor
University Health Network, Toronto
Study ID
NCT04563338
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    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.
  • Bevacizumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 4, 2021
Status verified
Mar 2026
Primary completion
Jun 25, 2024
Completion
Aug 31, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (Liver Cancer)
    Atezolizumab: 1200 mg, intravenously (IV), every 3 weeks Bevacizumab: 15 mg/kg, intravenously (IV), every 3 weeks
  • Experimental: Arm B (Lung Cancer)
    Atezolizumab: 1200 mg, intravenously (IV), every 3 weeks Bevacizumab: 15 mg/kg, intravenously (IV), every 3 weeks
  • Experimental: Arm C (Lung Cancer)
    Atezolizumab: 1200 mg, intravenously (IV), every 3 weeks

Primary Outcome Measure

Progression-free survival [ Time Frame: 4 years ]

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