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)
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.
• 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.
• Be tested for Hepatitis B-virus surface antigen (HBsAg) status. Patients may be included in the study if they have adequately controlled hepatitis B
• Patients must be tested for hepatitis C virus (HCV) status. Subjects with chronic infection by HCV who are untreated are allowed on study. In addition, subjects with successful HCV treatment are allowed as long as 4 weeks have passed between completion of HCV therapy and start of study treatment.
• Demonstrate adequate organ function.
• Agrees to use use highly effective contraceptive methods, not donate egg or sperm, during study participation, and for at least 6 months after the last dose of study medications.
• Life expectancy expected to be 3 months or greater.