In stage IIB and IIC melanoma (a thick tumour without spread to the lymph nodes), one year of pembrolizumab after surgery lowered the risk of the disease coming back and spreading over 4 years of follow-up.
Stage IIB, IIC or III melanoma after complete resection (adults and children aged 12 years and older)
| 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) |
Per the FDA label; children aged 12 years and older: 2 mg/kg every 3 weeks (maximum 200 mg). Evidence:.
On the page “Melanoma (skin cancer)” · Resectable melanoma: neoadjuvant and adjuvant
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.
Part 1: pembrolizumab 200 mg (in children 2 mg/kg, maximum 200 mg) as an IV infusion every 3 weeks for up to 17 cycles (about 1 year) or until recurrence or unacceptable toxicity. Part 2: patients who completed 17 cycles and then had a recurrence could be rechallenged at the same dose for up to 35 cycles (about 2 years).
Part 1: placebo (saline) IV every 3 weeks for up to 17 cycles. Part 2: patients with recurrence after completing placebo could cross over to pembrolizumab 200 mg every 3 weeks for up to 35 cycles.
Source of the regimen details: Abstract of the paper and ClinicalTrials.gov NCT03553836
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 years and older with newly diagnosed, completely resected stage IIB or IIC cutaneous melanoma (AJCC 8th edition; T3b or T4 with a negative sentinel lymph node biopsy), with no previous treatment other than surgery, no more than 12 weeks between final surgery and randomisation, no evidence of metastases on imaging and ECOG 0 or 1 (or the paediatric equivalent) (ClinicalTrials.gov NCT03553836).
Primary: recurrence-free survival; secondary: distant metastasis-free survival; also PRFS2 and the results of crossover and rechallenge (part 2).
No new safety signal was seen in this analysis. At the first interim analysis (Lancet 2022), treatment-related grade 3–4 adverse events occurred in 16% of pembrolizumab patients and 4% of placebo patients, and no treatment-related deaths were reported.
Confirms the durable benefit of adjuvant pembrolizumab in stage IIB/IIC; the ESMO 2025 guideline considers adjuvant pembrolizumab or nivolumab an option in this stage at level I, A.
This is a 4-year post hoc analysis; overall survival data are immature and the confidence interval for PRFS2 crosses 1.
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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