A newer report of this study has been published: Pembrolizumab versus placebo as adjuvant therapy in resected stage IIB or IIC melanoma: Long-term follow-up, crossover, and rechallenge with pembrolizumab in the phase III KEYNOTE-716 study (2025)
Thick or ulcerated melanomas (stage IIB and IIC) carry a considerable risk of coming back, even when the lymph nodes are not affected. This study showed that one year of pembrolizumab after surgery lowers the risk of the cancer coming back by about 35 to 40 percent. The decision to have treatment should take possible side effects into account, including permanent hormone-related side effects.
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 endpoint: investigator-assessed recurrence-free survival in the intention-to-treat population (first and second interim analyses).
Treatment-related grade 3–4 adverse events at the first interim analysis: 16% (78 of 483) with pembrolizumab versus 4% (21 of 486) with placebo. There were no treatment-related deaths.
KEYNOTE-716 led to the FDA approval of adjuvant pembrolizumab for stage IIB and IIC melanoma in adults and children aged 12 years and older (December 2021). Nivolumab has also been approved in this stage on the basis of CheckMate 76K. Guidelines present this option after a discussion of benefits and risks.
The results are based on interim analyses of recurrence-free survival and there are no overall survival data in this paper; most participants were white; chronic immune-mediated adverse events (such as hypothyroidism) must be weighed in patients, many of whom are cured by surgery alone.
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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