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NCT05002569 · ClinicalTrials.gov registry record · Phase 3

A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma

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

Terminated
Registry status
Phase 3
Development phase
1,093
Enrollment target

NCT05002569: Clinical Trial Phase 3 study, sponsored by Bristol-Myers Squibb.

NCT05002569 is a Phase 3 study that was terminated before completion, run by Bristol-Myers Squibb. The registered enrollment target is 1,093 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05002569, a Phase 3 study, was terminated before completion, sponsored by Bristol-Myers Squibb.

TERMINATED
Registry status
Phase 3
Development phase
1,093 participants
Enrollment target

Study Summary

The purpose of this study is to assess nivolumab plus relatlimab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.

Primary Outcome

RFS is defined as the time between the date of randomization and the first date of documented recurrence (local, regional, distant, new primary melanoma) or death due to any cause, whichever occurs first.

Interventions

  • BIOLOGICAL Nivolumab
  • BIOLOGICAL Nivolumab + Relatlimab Fixed Dose Combination

Trial Details

FieldValue
Enrollment Target 1,093 participants
Start Date 2021-10-19
Est. Completion 2025-04-02
Phase Phase 3
Bristol-Myers Squibb

1,025 total trials

Why NCT05002569 stopped before completion

NCT05002569 is an interventional study that assigns participants to a tested intervention. Its 1,093 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% higher).

The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.

NCT05002569 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05002569 about?

NCT05002569 is a clinical study titled "A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma". The purpose of this study is to assess nivolumab plus relatlimab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.

What is the current status of trial NCT05002569?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,093 participants. The study started on 2021-10-19. Estimated completion is 2025-04-02.

What interventions are being tested in trial NCT05002569?

The interventions under investigation include: Nivolumab (BIOLOGICAL), Nivolumab + Relatlimab Fixed Dose Combination (BIOLOGICAL).

Who is sponsoring clinical trial NCT05002569?

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

How this trial's enrollment target compares

Where NCT05002569's enrollment target sits among peer trials

1,093 266th of 2000 higher than 1,735 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT05002569, the US trial registry maintained by the National Library of Medicine. NCT05002569 (large enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.