A newer report of this study has been published: Nivolumab plus relatlimab in advanced melanoma: RELATIVITY-047 4-year update (2025)
Relatlimab is a new immunotherapy drug that releases another "brake" (LAG-3) on immune cells. Adding it to nivolumab in one monthly infusion more than doubled the time advanced melanoma was kept under control (median 10 vs 5 months), with fewer severe side effects than the combination of nivolumab and ipilimumab.
Unresectable or metastatic melanoma, first line (ESMO: I, B); or after failure of anti-PD-1 monotherapy
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Nivolumab + relatlimab (fixed-dose combination) | 480 mg nivolumab + 160 mg relatlimab | IV, 30-minute infusion | Day 1 every 4 weeks |
Per the FDA label; for adults and children aged 12 years and older weighing at least 40 kg.
On the page “Melanoma (skin cancer)” · Unresectable or metastatic melanoma: first-line immunotherapy
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Fixed-dose combination of relatlimab 160 mg + nivolumab 480 mg in a single 60-minute IV infusion every 4 weeks, until disease progression, unacceptable toxicity or withdrawal. (The current FDA label recommends a 30-minute infusion.)
Nivolumab 480 mg as a 60-minute IV infusion every 4 weeks, until disease progression, unacceptable toxicity or withdrawal.
Source of the regimen details: Full text of the paper (PMC9844513) and the FDA label (OPDUALAG)
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Patients aged 12 or older with histologically confirmed unresectable stage III or IV melanoma, without prior treatment for advanced disease, with measurable disease (RECIST 1.1) and tissue evaluable for LAG-3 and PD-L1. Prior adjuvant/neoadjuvant treatment with a PD-1, CTLA-4, BRAF or MEK inhibitor was allowed if completed at least 6 months before recurrence. Uveal melanoma and active untreated brain or leptomeningeal metastases were excluded. Stratified by LAG-3 and PD-L1 expression, BRAF V600 mutation and metastasis stage/LDH.
Primary outcome: progression-free survival by blinded independent central review. Secondary: overall survival and objective response.
Grade 3 or 4 treatment-related adverse events: 18.9% with relatlimab–nivolumab versus 9.7% with nivolumab; no new safety signal was observed (lower than the rate reported for nivolumab–ipilimumab in other trials, although there is no direct comparison).
RELATIVITY-047 led to FDA approval of the fixed-dose nivolumab–relatlimab combination (Opdualag; March 2022) for advanced melanoma in adults and children aged 12 and older, and this combination is now one of the three first-line immunotherapy options in guidelines (alongside anti-PD-1 monotherapy and nivolumab–ipilimumab).
The overall survival difference was not statistically significant in later analyses; there is no direct comparison with nivolumab–ipilimumab; patients with active brain metastases and ocular melanoma were not enrolled.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.
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