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NCT03055013 · ClinicalTrials.gov record · last posted 2026-07-31

Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing Nephrectomy

StatusActive, Not Recruiting
PhasePhase 3
Started2017-04-28
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from the ClinicalTrials.gov record
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.

Amendment record 636 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 636 times since 2017-02-15; most recent amendment 2026-07-01. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2021-06-11
Status change Recruiting→Active, Not Recruitingv554
Trial Details
NCT Number NCT03055013
Lead Sponsor National Cancer Institute (NCI)
Collaborators: Canadian Cancer Trials Group
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
Enrollment 819 participants
Start Date 2017-04-28
Primary Completion 2023-05-24 (estimated)
Study Completion 2031-06-09 (estimated)
Updated on ClinicalTrials.gov 2026-07-31