A clinical trial is a study conducted with actual patients, usually to evaluate a new treatment. Each study is designed to answer scientific questions and to find new and better ways to help patients.
Technical Title: PROSPER RCC: EA8143: A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy
Disease Type: Patients with renal cell carcinoma (a type of kidney cancer) who are planned to have a nephrectomy (surgical removal of the kidney)
Basic information: The purpose of this study is to compare the effects of a drug called nivolumab (also known as OPDIVO®), before and after the kidney cancer surgery to using the usual approach of surgically removing the kidney cancer followed by standard post-operative follow-up and monitoring. Nivolumab is a drug that may help stimulate your immune system to attack any cancer cells that may remain after surgery. The addition of nivolumab to the usual surgery could prevent your cancer from returning but it could also cause side effects.
For More Detailed Information, Contact:
• Brian Shuch, MD, Principal Investigator
• Rosleen Mala, Study Coordinator, (310) 794-3879
Official Study 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.
Objective of the study (lay terms): 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.
Investigator: Allan Pantuck, MD
Sponsor: Genentech (WO39210)
Read more about this study on ClinicalTrials.gov
For information on inclusion and exclusion criteria please call our Clinical Trials Office - 310-206-5930