Adjuvant Treatment for Completely Resected AJCC8 Stage IIB–IIC Cutaneous Melanoma in Patients Aged 12 and Older
This protocol covers the adjuvant management of cutaneous amelanocytic melanoma after complete surgical resection in patients staged AJCC8 IIB or IIC, aged 12 years and older — a population at elevated risk of recurrence despite clear margins.
Clinical scenario
Completely resected AJCC8 stage IIB–IIC cutaneous melanoma in patients aged 12 years and older. Following complete resection, this population is eligible for adjuvant systemic therapy. Regulatory approval for adjuvant treatment in this specific setting was granted by the EMA in June 2022.
Treatment approach partial — full regimen in protocol
The recommended approach involves adjuvant anti-PD-1 immunotherapy. Options carrying high-level evidence (ESMO-MCBS v1.1 score: A) are available; treatment discussions should address the demonstrated benefit in recurrence-free survival alongside the current maturity of overall survival data. The complete regimen, agent selection, and scheduling are detailed in the full protocol.
References
DOI: 10.1016/j.annonc.2024.11.006
- In June 2022, the EMA approved the use of adjuvant pembrolizumab for patients 12 years old with stage IIB-IIC melanoma following complete resection.
- 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].
- 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.
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