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NCT03055013 · ClinicalTrials.gov registry record · Phase 3
Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing Nephrectomy
A Phase 3 study of Metastatic Renal Cell Carcinoma and Stage III Renal Cell Cancer AJCC v7, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 3
- Development phase
- 819
- Enrollment target
- 20
- Study locations
NCT03055013: Active Phase 3 study of Metastatic Renal Cell Carcinoma and Stage III Renal Cell Cancer AJCC v7, sponsored by National Cancer Institute (NCI).
NCT03055013 is a Phase 3 study of Metastatic Renal Cell Carcinoma and Stage III Renal Cell Cancer AJCC v7 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 819 participants, above the 121-participant average among 37 other Metastatic Renal Cell Carcinoma trials with a reported enrollment target (577% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03055013, a Phase 3 study of Metastatic Renal Cell Carcinoma and Stage III Renal Cell Cancer AJCC v7, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 819 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
RFS is defined as time from randomization to disease recurrence or death from any cause. Patients who did not undergo nephrectomy or were not disease-free following nephrectomy were considered as having an event at day 1. Patients that are alive without an event were censored at the date of last disease evaluation. RFS rate at 5 years was the proportion of patients who are recurrence-free and alive at 5 years based on Kaplan-Meier estimates.
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 |
What the registry record for NCT03055013 still lists
NCT03055013 is an interventional study that assigns participants to a tested intervention. The registered 819 participants enrollment target is mid-sized for trials with a published cap, above the 121-participant average among 37 other Metastatic Renal Cell Carcinoma trials with a reported enrollment target (577% higher).
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.
NCT03055013 names 20 study sites across 3 states, led by California, Arizona, Alabama.
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.
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).
Who is sponsoring clinical trial NCT03055013?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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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Where NCT03055013's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Renal Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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