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Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing Nephrectomy
NCT03055013 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- BIOLOGICAL Nivolumab
- OTHER Patient Observation
- PROCEDURE Nephrectomy
Study Locations (20)
California
- Kaiser Permanente-Anaheim — Anaheim
- Sutter Auburn Faith Hospital — Auburn
- AIS Cancer Center at San Joaquin Community Hospital — Bakersfield
- Kaiser Permanente-Baldwin Park — Baldwin Park
- Kaiser Permanente-Bellflower — Bellflower
- Alta Bates Summit Medical Center-Herrick Campus — Berkeley
- Mills-Peninsula Medical Center — Burlingame
- Community Cancer Institute — Clovis
- City of Hope Comprehensive Cancer Center — Duarte
- Kaiser Permanente-Fontana — Fontana
- Kaiser Permanente South Bay — Harbor City
- Kaiser Permanente-Irvine — Irvine
- UC San Diego Moores Cancer Center — La Jolla
- Kaiser Permanente Los Angeles Medical Center — Los Angeles
Arizona
- Banner MD Anderson Cancer Center — Gilbert
- Cancer Center at Saint Joseph's — Phoenix
- Banner University Medical Center - Tucson — Tucson
- University of Arizona Cancer Center-North Campus — Tucson
Alabama
- University of Alabama at Birmingham Cancer Center — Birmingham
- Veterans Administration Medical Center - Birmingham — Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 819 participants |
| Start Date | 2017-04-28 |
| Est. Completion | 2031-06-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03055013
The ClinicalTrials.gov registry entry for NCT03055013 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 819 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Metastatic Renal Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions — of which Quality-of-Life Assessment is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03055013 reports 20 study locations spanning 3 distinct geographic areas — top geographies include California, Arizona, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03055013 about?
NCT03055013 is a clinical study titled "Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing Nephrectomy". 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 (localize...
What is the current status of trial NCT03055013?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 819 participants. The study started on 2017-04-28. Estimated completion is 2031-06-09.
What conditions does trial NCT03055013 study?
This clinical trial studies the following conditions: Metastatic Renal Cell Carcinoma, Stage III Renal Cell Cancer AJCC v7, Unclassified Renal Cell Carcinoma, Sarcomatoid Renal Cell Carcinoma, Stage II Renal Cell Cancer AJCC v7. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03055013?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Nivolumab (BIOLOGICAL), Patient Observation (OTHER), Nephrectomy (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03055013?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03055013 being conducted?
This trial has 20 study locations across Alabama, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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