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NCT04039607 · ClinicalTrials.gov registry record · Phase 3

A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma

A Phase 3 study of Hepatocellular Carcinoma, sponsored by Bristol-Myers Squibb.

Active
Registry status
Phase 3
Development phase
732
Enrollment target
20
Study locations

NCT04039607 is a Phase 3 study of Hepatocellular Carcinoma that is active but no longer recruiting, run by Bristol-Myers Squibb. The registered enrollment target is 732 participants, above the 252-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (190% higher). The trial reports 20 study locations across 14 states.

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The verdict

NCT04039607, a Phase 3 study of Hepatocellular Carcinoma, is active but no longer recruiting, sponsored by Bristol-Myers Squibb.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
732 participants
Enrollment target
20
Study locations

Study Summary

The main purpose of this study is to compare the overall survival (OS) of nivolumab plus ipilimumab versus standard of care (SOC) (sorafenib or lenvatinib) in all randomized participants with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

Conditions Studied

Hepatocellular Carcinoma

Interventions

  • DRUG Nivolumab
  • DRUG Ipilimumab
  • DRUG Sorafenib
  • DRUG lenvatinib

Study Locations (20)

Texas

  • Local Institution - 0304 - Dallas
  • Local Institution - 0202 - Houston
  • Local Institution - 0046 - Lubbock

California

  • Local Institution - 0288 - Coronado
  • Local Institution - 0157 - Duarte

Michigan

  • Local Institution - Ann Arbor
  • Local Institution - 0018 - Detroit

Buenos Aires

  • Local Institution - 0037 - Caba
  • Local Institution - 0194 - Pilar

Other

  • Local Institution - 0136 - Buenos Aires
  • Local Institution - 0058 - San Miguel de Tucumán

Arizona

  • Local Institution - 0292 - Tucson

District of Columbia

  • Local Institution - 0077 - Washington D.C.

Kentucky

  • Local Institution - 0027 - Louisville

Trial Details

FieldValue
Enrollment Target 732 participants
Start Date 2019-09-30
Est. Completion 2026-11-09
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 NCT04039607

The ClinicalTrials.gov registry entry for NCT04039607 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 732 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 252-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (190% higher). The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Nivolumab is the first listed.

NCT04039607 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Texas, California, Michigan.

Frequently Asked Questions

What is clinical trial NCT04039607 about?

NCT04039607 is a clinical study titled "A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma". The main purpose of this study is to compare the overall survival (OS) of nivolumab plus ipilimumab versus standard of care (SOC) (sorafenib or lenvatinib) in all randomized participants with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

What is the current status of trial NCT04039607?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 732 participants. The study started on 2019-09-30. Estimated completion is 2026-11-09.

What conditions does trial NCT04039607 study?

This clinical trial studies the following conditions: Hepatocellular Carcinoma.

What interventions are being tested in trial NCT04039607?

The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), Sorafenib (DRUG), lenvatinib (DRUG).

Who is sponsoring clinical trial NCT04039607?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04039607 being conducted?

This trial has 20 study locations across Arizona, California, District of Columbia, Kentucky, Maryland. 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.