Phase III study in Adjuvant Therapy in Renal Cell Carcinoma patients (Genentech WO39210)
Technical Title: A Phase III, Multicenter, Randomized, Placebo-Controlled, Double Blind Study of Atezolizumab (Anti−Pd-L1 Antibody) as Adjuvant Therapy in Patients with Renal Cell Carcinoma at High Risk of Developing Metastasis Following Nephrectomy
Disease Type: Renal cell carcinoma (RCC)
The purpose of this study is to compare the effects, good or bad, of atezolizumab versus placebo on RCC to find out which is better. Atezolizumab is the experimental drug in this study. Placebo is an inactive substance that looks like atezolizumab.
This study is for patients who are at high risk of their disease recurring after their nephrectomy (surgical procedure to remove all or part of a kidney) or metastasectomy (removal of cancerous growth that has spread away from your kidney).
Participants in this study will be randomized to receive either atezolizumab or placebo. The study drug will be given intravenously (IV, by vein) in the clinic every 3 weeks.
Research Procedures (not a complete list):
To participate in this study, you must be able to start study treatment within 12 weeks of your nephrectomy. You will come to the clinic every 3 weeks to receive Atezolizumab or placebo and complete study procedures such as physical exam, safety blood and urine tests, electrocardiogram, and research blood tests. You will undergo imaging tests (such as MRI and CT) every 3 months in the first 3 years and every 6 months thereafter to see if your RCC has recurred. When the imaging tests show that you may have recurred, you will undergo another biopsy to collect tissue for research.
Eligibility Criteria (Not a complete list):
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