This protocol covers the management of patients with resectable stage III cutaneous melanoma and pathologically proven, clinically or radiologically detectable lymph node metastasis who did not achieve major pathological response (MPR) following neoadjuvant immunotherapy and surgery.
Resectable stage III cutaneous melanoma with pathologically proven, clinically or radiologically detectable lymph node metastasis. Regional nodal involvement has been confirmed, and surgical resection is feasible.
Patients received neoadjuvant nivolumab plus ipilimumab (two cycles) followed by surgery, or alternatively neoadjuvant plus adjuvant pembrolizumab, as the first-line approach. The escalation criterion to this protocol is non-achievement of major pathological response (MPR) as defined by INMC criteria. Where MPR was not reached after surgery, further management is required.
Following surgery, adjuvant systemic therapy is the indicated next step, with the approach guided by the tumor's molecular characteristics. The full protocol specifies the treatment options and selection criteria — see below.
For patients with resectable stage III melanoma and pathologically proven, clinically or radiologically detectable LN metastasis, neoadjuvant nivolumab+ipilimumab [ESMO-MCBS v1.1 score: A; not EMA or FDA approved] followed by surgery should be offered.
In the neoadjuvant group, only patients who had a pPR or pNR received subsequent adjuvant treatment with either dabrafenib+trametinib (for BRAF-mutated melanoma) or nivolumab.
DOI: 10.1016/j.annonc.2024.11.006
View source ↗