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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 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.

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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

Hepatocellular Carcinoma Liver Cancer

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

FieldValue
Enrollment Target 545 participants
Start Date 2018-04-18
Est. Completion 2031-02-27
Phase Phase 3

Sponsor

Bristol-Myers Squibb

1,025 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03383458

The ClinicalTrials.gov registry entry for NCT03383458 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 545 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 254-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (115% higher). The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.