This study showed that if the same drug, pembrolizumab, is given partly before surgery (3 doses) and the rest after surgery, the result is better than giving all of it after surgery: after 2 years, 72% versus 49% of patients had had no event (such as the cancer coming back), with no increase in side effects. A possible explanation is that having the tumour still in the body when immunotherapy starts triggers a stronger immune response.
Measurable, resectable stage IIIB to IVC melanoma with clinically detectable disease
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Neoadjuvant | |||
| Pembrolizumab | 200 mg | IV, 30-minute infusion | Day 1 every 3 weeks, 3 doses; surgery within 3 weeks afterward |
| Adjuvant | |||
| Pembrolizumab | 200 mg | IV, 30-minute infusion | Day 1 every 3 weeks, 15 doses (starting within 84 days after surgery) |
Doses from the trial and ClinicalTrials.gov NCT03698019.
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.
Pembrolizumab 200 mg as a 30-minute IV infusion on day 1 every 3 weeks for 3 cycles, then surgery within 3 weeks; and within 84 days after surgery, pembrolizumab 200 mg every 3 weeks for 15 cycles, in the absence of progression or unacceptable toxicity (154 patients). Postoperative radiotherapy at the investigator's discretion was allowed before starting adjuvant therapy (not concurrently with pembrolizumab).
Surgery followed (preferably within 14 days and at most 17 days) by pembrolizumab 200 mg as a 30-minute IV infusion on day 1 every 3 weeks, 18 doses in total (about 1 year) or until recurrence or unacceptable toxicity (159 patients).
Source of the regimen details: Abstract of the paper, full text of the paper (PMC10410527) and ClinicalTrials.gov NCT03698019
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 clinically detectable, measurable, resectable stage IIIB to IVC melanoma, at initial presentation or at first nodal metastasis (including recurrence in a previous lymphadenectomy field), satellite, in-transit or distant; local recurrence only in the scar or surgical bed was not accepted. Prior adjuvant therapy (other than immunotherapy) or prior radiotherapy was allowed; HIV-positive patients with CD4 of at least 350 and viral load below 25,000 IU/mL were allowed.
Primary outcome: event-free survival in the intention-to-treat population (events included progression or toxicity precluding surgery, inability to achieve complete resection, a delay of more than 84 days in starting adjuvant therapy, recurrence and death). Safety was also assessed.
Grade 3 or higher treatment-related adverse events during treatment: 12% in the neoadjuvant–adjuvant group and 14% in the adjuvant-only group; no new toxic effects were identified.
SWOG S1801 was the first randomised trial to show the superiority of neoadjuvant sequencing with the same drug and, together with NADINA, became the basis for guideline recommendations of neoadjuvant immunotherapy in resectable melanoma. The 2025 ESMO guideline recommends neoadjuvant plus adjuvant pembrolizumab for resectable stage III melanoma [II, A] (at the time of the guideline's publication, without formal EMA or FDA approval for this use).
Phase 2 trial with relatively short follow-up; overall survival data immature; the definition of "event" included surgery-related events; pathological response assessment was not standardised.
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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