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NCT03383458 · ClinicalTrials.gov registry record · Phase 3
A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation
A Phase 3 study of Hepatocellular Carcinoma and Liver Cancer, sponsored by Bristol-Myers Squibb.
- Active
- Registry status
- Phase 3
- Development phase
- 545
- Enrollment target
- 20
- Study locations
NCT03383458: Active Phase 3 study of Hepatocellular Carcinoma and Liver Cancer, sponsored by Bristol-Myers Squibb.
NCT03383458 is a Phase 3 study of Hepatocellular Carcinoma and Liver Cancer that is active but no longer recruiting, run by Bristol-Myers Squibb. The registered enrollment target is 545 participants, above the 254-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (115% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03383458, a Phase 3 study of Hepatocellular Carcinoma and Liver Cancer, is active but no longer recruiting, sponsored by Bristol-Myers Squibb.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 545 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Nivolumab
Study Locations (20)
New York
- Local Institution - 0075 - New York
- Local Institution - 0208 - New York
- Local Institution - 0045 - New York
- Local Institution - 0219 - White Plains
California
- Local Institution - 0135 - Los Angeles
- Local Institution - 0088 - Palo Alto
- Local Institution - 0085 - San Francisco
Florida
- Local Institution - 0267 - Miami
- Sylvester Comprehensive Cancer Center/ UMHC - Miami
- Local Institution - 0163 - Tampa
Arizona
- Mayo Clinic in Arizona - Phoenix - Phoenix
- Arizona Oncology Associates, PC - HOPE - Tucson
Alabama
- Local Institution - 0081 - Anniston
Colorado
- Local Institution - 0235 - Aurora
Georgia
- Local Institution - 0009 - Atlanta
Kansas
- Local Institution - 0025 - Westwood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 545 participants |
| Start Date | 2018-04-18 |
| Est. Completion | 2031-02-27 |
| Phase | Phase 3 |
What the registry record for NCT03383458 still lists
NCT03383458 is an interventional study that assigns participants to a tested intervention. The registered 545 participants enrollment target is mid-sized for trials with a published cap, above the 254-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (115% higher).
The record links to 2 conditions, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03383458 names 20 study sites across 12 states, led by New York, California, Florida.
Frequently Asked Questions
What is clinical trial NCT03383458 about?
NCT03383458 is a clinical study titled "A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation". This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence
What is the current status of trial NCT03383458?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 545 participants. The study started on 2018-04-18. Estimated completion is 2031-02-27.
What conditions does trial NCT03383458 study?
This clinical trial studies the following conditions: Hepatocellular Carcinoma, Liver Cancer.
What interventions are being tested in trial NCT03383458?
The interventions under investigation include: Placebo (OTHER), Nivolumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03383458?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03383458 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatocellular Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03383458's enrollment target sits among peer trials
545 24th of 145 higher than 122 of 145 other Hepatocellular Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatocellular 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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