RELATIVITY-047 — Nivolumab Plus Relatlimab Versus Nivolumab in Untreated Advanced Melanoma (RELATIVITY-047)

Phase 2/3 · 2022 · Melanoma

Design

Randomized double-blind trial of the fixed-dose combination of nivolumab plus relatlimab versus nivolumab alone.

Population

Previously untreated metastatic or unresectable melanoma.

Primary Endpoint

progression-free survival (PFS)

Key Result

3-year update (median follow-up 33.8 mo): PFS 10.2 vs 4.6 mo (HR 0.79); OS 51.0 vs 34.1 mo (HR 0.80, upper CI now <1); ORR 43.7% vs 33.7%.

Guideline Impact

NCCN category 1 nivolumab plus relatlimab for first-line advanced melanoma