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NCT02596035 · ClinicalTrials.gov registry record · Phase 4
An Investigational Immuno-therapy Safety Trial of Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma
A Phase 4 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 4
- Development phase
- 197
- Enrollment target
NCT02596035: Completed Phase 4 study, sponsored by Bristol-Myers Squibb.
NCT02596035 is a Phase 4 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 197 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02596035, a Phase 4 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 197 participants
- Enrollment target
Study Summary
This study will generate safety data on Nivolumab given by itself in treatment of advanced Renal Cell Carcinoma (RCC). The primary objective of this study is to assess immune related side effects, also known as immune-mediated adverse events (IMAEs), in patients treated with Nivolumab.
Primary Outcome
IMAEs were tabulated using worst grade per Common Terminology Criteria for Adverse Events, National Cancer Institute (NCI CTCAE) Version 4.0 criteria by system organ class and MedDRA version 20.1 preferred term.
Interventions
- DRUG Nivolumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 197 participants |
| Start Date | 2016-01-08 |
| Est. Completion | 2021-05-24 |
| Phase | Phase 4 |
What the finished NCT02596035 record still lists
NCT02596035 is an interventional study that assigns participants to a tested intervention. The registered 197 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which Nivolumab is the first listed.
NCT02596035 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02596035 about?
NCT02596035 is a clinical study titled "An Investigational Immuno-therapy Safety Trial of Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma". This study will generate safety data on Nivolumab given by itself in treatment of advanced Renal Cell Carcinoma (RCC). The primary objective of this study is to assess immune related side effects, also known as immune-mediated adverse events (IMAEs), in patients treated with Nivolumab.
What is the current status of trial NCT02596035?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 197 participants. The study started on 2016-01-08. Estimated completion is 2021-05-24.
What interventions are being tested in trial NCT02596035?
The interventions under investigation include: Nivolumab (DRUG).
Who is sponsoring clinical trial NCT02596035?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02596035's enrollment target sits among peer trials
197 448th of 2000 higher than 1,552 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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