# A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma

Source: https://onco.cc/trials/nct05625399/  
OnCo record `nct05625399` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Nivolumab, Relatlimab + nivolumab in melanoma, run by Bristol-Myers Squibb, active and no longer recruiting.

## Summary

A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma is a phase 3 interventional study registered as NCT05625399 by Bristol-Myers Squibb, with 579 participants enrolled, started 2023-03-06 and due to reach its primary completion in 2025-08-04. Interventions recorded: Nivolumab + Relatlimab, rHuPH20. Conditions listed: Melanoma. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-22
- Also known as: RELATIVITY-127
- Tags: ctgov-ingest
- Registry id: NCT05625399
- Phase: 3
- Setting: A Phase 3, Randomized, Open-label, Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination Versus Intravenous Nivolumab + Relatlimab Fixed-dose Combination in Participants With Previously Untreated Metastatic or Unresectable Melanoma
- Sponsor: Bristol-Myers Squibb
- Enrolled: 579
- Outcomes: Adjusted Time-Averaged Nivolumab Serum Concentration Over the First 28 Days (Cavgd28-Nivo) on Natural Logarithmic Scale: Nivo + Rela FDC SC 4.141 ug/ml vs Nivo + Rela FDC IV 3.901 ug/ml; Progression Free Survival Per BICR: Nivo + Rela FDC SC 12.65 months vs Nivo + Rela FDC IV 14.98 months; Disease Control Rate (ORR) Per BICR: Nivo + Rela FDC SC 62.2% vs Nivo + Rela FDC IV 72.3%

## Sources

- ClinicalTrials.gov NCT05625399: https://clinicaltrials.gov/study/NCT05625399

## Connected records

- cancers: [Advanced melanoma (unresectable stage III and stage IV)](https://onco.cc/cancers/advanced-melanoma/), [Melanoma](https://onco.cc/cancers/melanoma/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- drugs: [Nivolumab](https://onco.cc/drugs/nivolumab/), [Relatlimab + nivolumab](https://onco.cc/drugs/relatlimab-nivolumab/)
- companies: [Bristol Myers Squibb](https://onco.cc/companies/bms/)

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