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Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing Nephrectomy

NCT03055013 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 819

Last updated 2026-05-04

Study results available
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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.

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

Interventions

PROCEDURE

Nephrectomy

Undergo nephrectomy

BIOLOGICAL

Nivolumab

Given IV

OTHER

Patient Observation

Undergo observation

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

  • Canadian Cancer Trials Group

    collaborator NETWORK

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Lauren Harshman · ECOG-ACRIN Cancer Research Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-28
Primary Completion
2023-05-24
Completion
2031-06-09
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Israel

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03055013 on ClinicalTrials.gov