OncRef

Clinical Trial: NCT03055013

Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing Nephrectomy

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:National Cancer Institute (NCI)
Information Provided By:National Cancer Institute (NCI)
Last Update Posted:2026-08-28

Study Overview

Brief Summary

This phase III trial compares nephrectomy (surgery to remove a kidney or part of a kidney) with nivolumab to the usual approach of nephrectomy followed by standard post-operative follow-up and monitoring, in treating patients with kidney cancer that is limited to a certain part of the body (localized). Nivolumab is a drug that may help stimulate the immune system to attack any cancer cells that may remain after surgery. The addition of nivolumab to the usual surgery could prevent the cancer from returning. It is not yet known whether nivolumab and nephrectomy is more effective than nephrectomy alone in treating patients with kidney cancer.

Official Title

A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients With Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)

Conditions

Metastatic Renal Cell Carcinoma, Sarcomatoid Renal Cell Carcinoma, Stage II Renal Cell Cancer AJCC v7, Stage III Renal Cell Cancer AJCC v7, Unclassified Renal Cell Carcinoma

Intervention / Treatment

  • Procedure: Nephrectomy
  • Biological: Nivolumab
  • Other: Patient Observation
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration

Other Study ID Numbers

  • NCI-2016-00326
  • NCI-2016-00326
  • EA8143
  • EA8143
  • EA8143
  • U10CA180820

Start Date (Actual)

2017-04-28

Primary Completion Date (Actual)

2023-05-24

Study Completion Date (Estimated)

2031-06-09

Enrollment (Actual)

819

Study Type

Interventional

Phase

Phase 3