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ECOG-ACRIN EA8143- Kidney Cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to see if the study drug Nivolumab taken before and after surgery for kidney cancer is better, the same, or worse than the standard follow-up after having had surgery for kidney cancer.

What is the Condition Being Studied?

Kidney Cancer (Renal Cell Carcinoma)

Who Can Participate in the Study?

Adults with kidney cancer who:
- Have no prior therapy for the kidney cancer
- Have no autoimmune or liver disease
- Are not pregnant or nursing

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Be randomized (like a flip of a coin) get either:
-- Group 1: The study drug nivolumab by an IV through your vein before and after surgery once a month for a total of 10 doses
-- Group 2: Surgery followed by observation
- Have CT or MRI scans to monitor your status for up to 6 years
- Have clinic visits every 6 months for 2-3 years and then yearly for 4-5 years

Study Details

Full Title
ECOG-ACRIN EA8143: A Phase 3 Randomized Study Comparing Perioperative Nivolumab versus Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00082493
NCT:NCT03055013
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698