An Open-Label Multi-Center Phase II Study of Neoadjuvant Atezolizumab-Based Combination Therapy in Men With Localized Prostate Cancer Prior to Radical Prostatectomy
David Oh
Summary
This phase II trial studies how well atezolizumab works alone or in combination with etrumadenant or tocilizumab in treating men with localized prostate cancer before radical prostatectomy. 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. Androgens can cause the growth of prostate cancer cells. IL-6 is expressed by prostate cancer and within the tumor microenvironment and shown to enhance prostate cancer and disease progression. Treatment with an anti-IL-6 antibody such as tocilizumab may inhibit cancer progression. Giving atezolizumab in combination with etrumadenant or tocilizumab may work better in treating prostate cancer.
Description
PRIMARY OBJECTIVES: I. To determine the impact of atezolizumab-based combination therapy on the composition and function of tumor-infiltrating immune cells (TIICS). SECONDARY OBJECTIVES: I. To determine the safety and tolerability of atezolizumab-based combination therapy in localized prostate cancer (PC). II. To determine the clinical efficacy of atezolizumab-based combination therapy in localized PC. EXPLORATORY OBJECTIVES: I. To characterize changes in the frequency and number of circulating immune cells following atezolizumab-based combination therapy in localized PC. II. To determi…