Melanoma
ICD-10 C43 · ICD-11 2C30

Adjuvant Treatment for Completely Resected Melanoma, AJCC8 Pathological Stage IIB–IIC, in Patients Aged 12 Years or Older

This protocol applies to patients with completely resected cutaneous melanoma at AJCC8 pathological stage IIB or IIC who are aged 12 years or older, covering both adult and adolescent populations.

Clinical scenario: The patient has undergone complete surgical resection of AJCC8 pathological stage IIB or IIC cutaneous melanoma and is aged 12 years or older. This staging reflects higher-risk localised disease without nodal involvement. The KEYNOTE-716 trial enrolled 976 patients across this age range to evaluate adjuvant systemic therapy in this setting.
Treatment approach: Adjuvant anti-PD-1 immunotherapy for a defined course is the recommended treatment class in this setting for eligible patients, with the choice of agent and schedule individualised to the patient. The complete regimen options, selection criteria, and full treatment algorithm are available in the structured protocol.
Instant Access to Structured Evidence-Based Regimens

References

In the KEYNOTE-716 trial, 976 patients (age 12 years) with completely resected AJCC8 pathological stage IIB-IIC melanoma received intravenous pembrolizumab 200 mg (2 mg/kg in paediatric patients) or placebo every 3 weeks (q3w) for 17 cycles or until disease recurrence or unacceptable toxicity.

Adjuvant therapy with either pembrolizumab [ESMO-MCBS v1.1 score: A] or nivolumab [ESMO-MCBS v1.1 score: A] for 12 months should be considered for patients with stage IIB-IIC disease; treatment discussions with the patient should include consideration of the RFS benefit but lack of mature OS data [I, A].

Patients with a negative SLNB can be offered standard follow-up [III, A], clinical trial participation [V, A] or anti-PD-1 therapy for 12 months (stages IIB-IIC) [I, A].

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