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NCT04099251 · ClinicalTrials.gov registry record · Phase 3

Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma

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

Active
Registry status
Phase 3
Development phase
790
Enrollment target
20
Study locations

NCT04099251 is a Phase 3 study of Melanoma that is active but no longer recruiting, run by Bristol-Myers Squibb. The registered enrollment target is 790 participants, above the 704-participant average among 266 other Melanoma trials with a reported enrollment target (12% higher). The trial reports 20 study locations across 11 states.

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The verdict

NCT04099251, a Phase 3 study of Melanoma, is active but no longer recruiting, sponsored by Bristol-Myers Squibb.

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

Study Summary

The purpose of this study is to determine the effectiveness of nivolumab adjuvant immunotherapy compared to placebo in adults and pediatric participants after complete resection of Stage IIB/C melanoma with no evidence of disease (NED) who are at high risk for recurrence.

Conditions Studied

Melanoma

Interventions

  • OTHER Placebo
  • BIOLOGICAL Nivolumab

Study Locations (20)

California

  • Local Institution - 0080 - Los Angeles
  • Local Institution - 0077 - San Francisco
  • Local Institution - 0119 - San Francisco
  • Local Institution - 0122 - San Jose
  • Local Institution - 0121 - Vallejo
  • Local Institution - 0109 - Vallejo
  • Local Institution - 0120 - Vallejo

Massachusetts

  • Local Institution - 0078 - Boston
  • Local Institution - 0127 - Boston
  • Local Institution - 0143 - Boston

Minnesota

  • Local Institution - 0151 - Minneapolis
  • Local Institution - 0081 - Robbinsdale

Alabama

  • Local Institution - 0088 - Birmingham

Arizona

  • Local Institution - 0126 - Tucson

Arkansas

  • Local Institution - 0087 - Springdale

Colorado

  • Local Institution - 0091 - Aurora

District of Columbia

  • Local Institution - 0089 - Washington D.C.

Trial Details

FieldValue
Enrollment Target 790 participants
Start Date 2019-10-28
Est. Completion 2027-06-29
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 NCT04099251

The ClinicalTrials.gov registry entry for NCT04099251 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 790 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 704-participant average among 266 other Melanoma trials with a reported enrollment target (12% 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 Melanoma appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04099251 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Massachusetts, Minnesota.

Frequently Asked Questions

What is clinical trial NCT04099251 about?

NCT04099251 is a clinical study titled "Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma". The purpose of this study is to determine the effectiveness of nivolumab adjuvant immunotherapy compared to placebo in adults and pediatric participants after complete resection of Stage IIB/C melanoma with no evidence of disease (NED) who are at high risk for recurrence.

What is the current status of trial NCT04099251?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 790 participants. The study started on 2019-10-28. Estimated completion is 2027-06-29.

What conditions does trial NCT04099251 study?

This clinical trial studies the following conditions: Melanoma.

What interventions are being tested in trial NCT04099251?

The interventions under investigation include: Placebo (OTHER), Nivolumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT04099251?

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

Where is trial NCT04099251 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. 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.