In advanced melanoma, single-drug immunotherapy with pembrolizumab helped people live longer than ipilimumab; after 10 years about one in three patients in the pembrolizumab group were alive, and most patients who completed two years of treatment were still alive years later.
Unresectable or metastatic melanoma, first line (or after targeted therapy if no prior anti-PD-1 therapy)
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Pembrolizumab | 200 mg (or 400 mg) | IV, 30-minute infusion | Day 1 every 3 weeks (400 mg dose: every 6 weeks) |
Dose per the FDA label; KEYNOTE-006 used 10 mg/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.
Pembrolizumab 10 mg/kg IV every 2 weeks or every 3 weeks (two randomised groups, pooled in this analysis) for up to about 24 months, or until progression or unacceptable toxicity; eligible patients could receive a second course of pembrolizumab after progression.
Ipilimumab 3 mg/kg IV every 3 weeks, 4 doses in total (about 3 months).
Source of the regimen details: Abstract of the paper and ClinicalTrials.gov NCT01866319 (the trial dose differs from the currently approved dose of pembrolizumab, 200 mg every 3 weeks or 400 mg every 6 weeks)
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 with unresectable stage III or metastatic melanoma not amenable to local therapy (excluding uveal or ocular melanoma), with at least one measurable lesion, ECOG 0 or 1, and either no prior systemic therapy (first line) or one prior systemic therapy (second line) for advanced disease (prior adjuvant/neoadjuvant therapy allowed); no prior anti-CTLA-4 or anti-PD-1 therapy (ClinicalTrials.gov).
Primary: overall survival; exploratory: modified progression-free survival, progression-free survival during a second course of pembrolizumab, and melanoma-specific survival.
Safety data are not reported in the abstract of this analysis.
This is the longest follow-up of single-agent anti-PD-1 therapy in advanced melanoma; the ESMO 2025 guideline recommends first-line single-agent pembrolizumab or nivolumab at level I, A.
The trial is open-label; only some patients moved to the long-term follow-up study, and the secondary endpoints are exploratory.
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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