A Phase II Randomized Study of Atezolizumab Plus Multi-Kinase Inhibitor Versus Multi-Kinase Inhibitor Alone in Subjects With Unresectable, Advanced Hepatocellular Carcinoma Who Previously Received Atezolizumab Plus Bevacizumab
Academic and Community Cancer Research United
Summary
This phase II trial tests whether atezolizumab in combination with a multi-kinase inhibitor (cabozantinib or lenvatinib) compared to multi-kinase inhibitor alone in treating patients with liver cancer that cannot be removed by surgery (unresectable), has spread to has spread to nearby tissue or lymph nodes (locally advanced), or has spread to other places in the body (metastatic), for which the patient has received treatment in the past (previously treated). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib and lenvatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving atezolizumab with cabozantinib or lenvatinib may kill more tumor cells in patients with liver cancer.
Description
PRIMARY OBJECTIVE: I. To determine the progression-free and overall survival in subjects with advanced hepatocellular carcinoma who previously progressed on atezolizumab/bevacizumab who are treated using atezolizumab plus a multi-kinase inhibitor compared to multi-kinase inhibitor alone. SECONDARY OBJECTIVES: I. To determine the overall response rate per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 response in subjects who are treated using atezolizumab plus a multi-kinase inhibitor compared to multi-kinase inhibitor alone. II. To determine the duration of response…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Provide written informed consent =\< 28 days prior to randomization * Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study) * NOTE: During the Active Monitoring Phase of a study (i.e., active treatment and clinical follow-up), participants must be willing to return to the consenting institution for follow-up * Age \>= 18 years * Hepatocellular carcinoma (HCC) confirmed by histological/cytological diagnosis or clinically per the American Association for the Study of Liver Diseases (AASLD) or WASL 2018 criteria * Loca…
Interventions
- BiologicalAtezolizumab
Given IV
- DrugCabozantinib
Given PO
- DrugLenvatinib
Given PO
Locations (16)
- Mayo Clinic in ArizonaScottsdale, Arizona
- Mayo Clinic in FloridaJacksonville, Florida
- Cleveland Clinic Weston FloridaWeston, Florida
- University of Chicago Comprehensive Cancer CenterChicago, Illinois
- Carle Cancer Center NCI Community Oncology Research ProgramUrbana, Illinois
- University Medical Center New OrleansNew Orleans, Louisiana