EA8143 A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)
Johns Hopkins Kimmel Cancer Center in Baltimore
Sibley Memorial Hospital
This research is being done to compare any good and bad effects of using nivolumab (also known as OPDIVO®), before and after kidney cancer surgery to using the usual approach of surgically removing the kidney cancer followed by standard post-operative follow-up and monitoring.
Patients with cancer in the kidney with plans to have it removed by a surgeon may be eligible.
This research study has two study groups.•If you are assigned to Group 1, you will get the study drug, nivolumab, before and after surgery for a total of 14 doses. Nivolumab is administered by an intravenous (IV) infusion over 30 minutes once every two weeks for two doses before surgery. After recovering from surgery, you will receive it every 2 weeks for 3 months then monthly for 6 more months for a total of 9 months of dosing after surgery. Dosing will continue for a maximum of 9 months after surgery (12 doses of nivolumab) or until you have side effects, your cancer returns, or you decide to stop.Group 1: A cycle is a term used to describe the schedule your course of study drug will follow. While you are on this study you will receive nivolumab on the first day of each cycle. There will be two 2 week cycles prior to your surgery. After your surgery there will be six 2 week cycles, followed by six 4 week cycles. There will be a total of 14 cycles.Group 2: If you are assigned to Group 2, you will undergo surgery to remove the kidney cancer, followed by standard post-operative follow-up monitoring for return of the cancer with radiology scans, doctor’s visits, bloodwork and physical exams. You will not receive nivolumab.You will be in this study for up to 10 years.If you are in Group 1, you will receive 2 doses of the nivolumab prior to surgery. One dose will be given every two weeks. Then starting at least 4 weeks after surgery you will receive 12 doses for 9 months. For the first 6 doses given after surgery, they will be given every 2 weeks. The last 6 doses will be given every 4 weeks. Participants in Group 1 will receive no more than 14 doses of nivolumab total. If you are in Group 2, you will be monitored after surgery, which is the usual approach for this disease. After you finish taking nivolumab, or if you are assigned to the observation group, your doctor will continue to monitor you for side effects if in Group 1 and follow your condition for both Group 1 and Group 2 for up to 10 years. This follow-up in both groups will include CT or MRI scans of your chest, abdomen, and pelvis; blood work, and physical exams to monitor your status.
12/11/2019 05:03 AM