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A phase 3 trial of Nivolumab, Relatlimab + nivolumab in melanoma, run by Bristol-Myers Squibb, active and no longer recruiting.
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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
579 enrolled.
SE 0.0167; Figures from the ClinicalTrials.gov results section (first posted 2026-08-26), not from a publication · SE 0.0164
Source95% CI 8.08 to NA; Figures from the ClinicalTrials.gov results section (first posted 2026-08-26), not from a publication · 95% CI 12.12 to NA
Source95% CI 56.3 to 67.9; Figures from the ClinicalTrials.gov results section (first posted 2026-08-26), not from a publication · 95% CI 66.7 to 77.3
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Adjusted Time-Averaged Nivolumab Serum Concentration Over the First 28 Days (Cavgd28-Nivo) on Natural Logarithmic Scaleprimary | Nivo + Rela FDC SC | 283 | 4.141 ug/ml | - | - | link |
| Nivo + Rela FDC IV | 291 | 3.901 ug/ml | ||||
| Progression Free Survival Per BICR | Nivo + Rela FDC SC | 286 | 12.65 months | - | - | link |
| Nivo + Rela FDC IV | 292 | 14.98 months | ||||
| Disease Control Rate (ORR) Per BICR | Nivo + Rela FDC SC | 286 | 62.2% | - | - | link |
| Nivo + Rela FDC IV | 292 | 72.3% |
Shares Relatlimab + nivolumab, Bristol Myers Squibb, Nivolumab, Melanoma.
Shares Relatlimab + nivolumab, Advanced melanoma (unresectable stage III and stage IV), Nivolumab, Melanoma.
Shares Advanced melanoma (unresectable stage III and stage IV), Nivolumab, Melanoma, Immune checkpoint inhibitors.
Shares Advanced melanoma (unresectable stage III and stage IV), Nivolumab, Melanoma, Immune checkpoint inhibitors.
Shares Advanced melanoma (unresectable stage III and stage IV), Nivolumab, Melanoma, Immune checkpoint inhibitors.
Shares Advanced melanoma (unresectable stage III and stage IV), Nivolumab, Melanoma, Immune checkpoint inhibitors.
Shares Bristol Myers Squibb, Nivolumab, Immune checkpoint inhibitors.
Shares Advanced melanoma (unresectable stage III and stage IV), Bristol Myers Squibb, Nivolumab, Melanoma.