The Absolute Effect / Oncology Evidence / Evidence Index

Melanoma · Medical · Advanced / Metastatic · First-line unresectable/metastatic melanoma

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 summary

Study design, population and eligibility

Design and sample

Phase II/III double-blind randomized; n=714.

Population

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

4-y PFS nivo/relatlimab
30.6%
4-y PFS nivolumab
23.6%

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.

Primary publication and authoritative source

https://pubmed.ncbi.nlm.nih.gov/40513285/

ClinicalTrials.gov NCT03470922