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…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: 1. Histologically confirmed adenocarcinoma of the prostate. a. Subjects with small cell or neuroendocrine PC are not eligible. 2. Eligible for radical prostatectomy as determined by urologic oncology surgeon, and subject consents to proceeding with radical prostatectomy. a. Deemed by urologic oncology surgeon to be appropriate for a "window-of-opportunity"study. 3. Only patients with high-risk disease are eligible for the safety lead-in for each cohort. Patients with intermediate-risk disease will be included after interim analyses is complete for the corresponding…
Interventions
- DrugAtezolizumab
Given IV
- DrugTocilizumab
Given IV
- DrugEtrumadenant
Given Orally
Locations (2)
- University of California, San FranciscoSan Francisco, California
- Alvin J. Siteman Cancer Center at Washington UniversitySt Louis, Missouri