The Absolute Effect / Oncology Evidence / Evidence Index
RELATIVITY-047
In previously untreated advanced melanoma, does nivolumab plus relatlimab improve progression-free survival over nivolumab alone?
Registry: NCT03470922 · Evidence reviewed 9 November 2026 · Aliases and follow-up publications consolidated.
Phase II/III double-blind randomized; n=714.Primary-source evidence summaryStudy design, population and eligibility
Phase II/III double-blind randomized; n=714.
Previously untreated unresectable/metastatic melanoma.
Treatment and comparator
Intervention: Nivolumab + relatlimab.
Comparator: Nivolumab.
Endpoints
PFS by BICR primary.
Key efficacy and clinical outcomes
At 4-y minimum follow-up PFS 30.6% vs 23.6%; OS 52.0% vs 42.8%; ORR 43.9% vs 33.4%.
Source-reported outcome visualization
Values are reproduced from the cited report; bars are scaled within this figure. First-line unresectable/metastatic melanoma
Median survival and hazard ratios are not fixed-time event risks; NNT is not inferred from them.
Toxicity and treatment burden
Dual PD-1/LAG-3 blockade increases grade 3–4 treatment-related AEs over nivolumab alone.
Absolute effect and NNT/NNH
No direct randomized comparison with nivolumab-ipilimumab.
NNT/NNH is not calculated unless a directly reported, comparable fixed-time risk difference supports it. Median survival and hazard ratios alone do not provide an NNT.
Critical interpretation and limitations
No direct randomized comparison with nivolumab-ipilimumab.
This page is an evidence summary, not a substitute for multidisciplinary assessment or patient-specific decision-making.
Current-practice context
Review date: 9 November 2026. Primary publication and selected follow-up sources were reviewed. Full disease-specific guideline, regulatory-label and sequencing audit remains pending; verify current local recommendations and biomarker eligibility before clinical application.