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NCT05625399 · ClinicalTrials.gov registry record · Phase 3
A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma
A Phase 3 study of Melanoma, sponsored by Bristol-Myers Squibb.
- Active
- Registry status
- Phase 3
- Development phase
- 579
- Enrollment target
- 20
- Study locations
NCT05625399: Active Phase 3 study of Melanoma, sponsored by Bristol-Myers Squibb.
NCT05625399 is a Phase 3 study of Melanoma that is active but no longer recruiting, run by Bristol-Myers Squibb. The registered enrollment target is 579 participants, below the 704-participant average among 266 other Melanoma trials with a reported enrollment target (18% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05625399, 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
- 579 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab + relatlimab FDC intravenous (IV) administration in participants with previously untreated metastatic or unresectable melanoma.
Primary Outcome
Blood samples were collected to assess serum concentration.
Conditions Studied
Interventions
- DRUG Nivolumab + Relatlimab
- DRUG rHuPH20
Study Locations (20)
New South Wales
- Local Institution - 0050 - Coffs Harbour
- Local Institution - 0175 - Orange
- Local Institution - 0172 - Port Macquarie
- Local Institution - 0118 - Wagga Wagga
- Local Institution - 0184 - Waratah
California
- Local Institution - 0098 - Los Angeles
- Local Institution - 0093 - Orange
- Local Institution - 0123 - Stanford
Pennsylvania
- Local Institution - 0139 - Easton
- Local Institution - 0124 - Philadelphia
Arizona
- Local Institution - 0125 - Phoenix
Arkansas
- Local Institution - 0189 - Springdale
Colorado
- Local Institution - 0113 - Englewood
Florida
- Local Institution - 0114 - Jacksonville
Maryland
- Local Institution - 0146 - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 579 participants |
| Start Date | 2023-03-06 |
| Est. Completion | 2027-11-18 |
| Phase | Phase 3 |
What the registry record for NCT05625399 still lists
NCT05625399 is an interventional study that assigns participants to a tested intervention. The registered 579 participants enrollment target is mid-sized for trials with a published cap, below the 704-participant average among 266 other Melanoma trials with a reported enrollment target (18% lower).
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 2 interventions - of which Nivolumab + Relatlimab is the first listed.
NCT05625399 names 20 study sites across 13 states, led by New South Wales, California, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05625399 about?
NCT05625399 is a clinical study titled "A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma". The purpose of this study is to demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab + relatlimab FDC intravenous (IV) administration in participants with previously untreated metastatic or unresectable melanoma.
What is the current status of trial NCT05625399?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 579 participants. The study started on 2023-03-06. Estimated completion is 2027-11-18.
What conditions does trial NCT05625399 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT05625399?
The interventions under investigation include: Nivolumab + Relatlimab (DRUG), rHuPH20 (DRUG).
Who is sponsoring clinical trial NCT05625399?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05625399 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Melanoma
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 NCT05625399's enrollment target sits among peer trials
579 34th of 266 higher than 233 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma 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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Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.
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