Adjuvant Treatment for Resected Melanoma Stage IIIB–IV with No Evidence of Disease
Clinical Scenario
This protocol addresses patients with melanoma who have undergone complete surgical resection and are currently at stage IIIB–IV with no evidence of residual disease (NED). The clinical question is which adjuvant systemic therapy to initiate after resection to reduce the risk of recurrence.
Patient Population
Patients with fully resected melanoma at stage IIIB, IIIC, IIID, or stage IV who have achieved a no-evidence-of-disease status following surgery. Treatment selection in this population is informed by disease stage and, where applicable, tumour molecular profile.
Treatment Approach (Summary)
Adjuvant systemic therapy is recommended and should be initiated within 12 weeks of complete resection. The approach involves immune checkpoint blockade and, for patients whose tumours carry a specific mutation, a targeted combination therapy may be appropriate instead. The full selection algorithm — including which agent applies to which stage and which molecular profile — is detailed in the structured protocol.
Dosing, sequencing, and the complete decision algorithm are available in the full protocol below.
References
- Adjuvant systemic therapy options are anti-PD-1 therapy (nivolumab for resected stage IIIB-IV NED [I, A; ESMO-MCBS v1.1 score: no evaluable benefit] or pembrolizumab for resected stage III [I, A; ESMO-MCBS v1.1 score: A]) or dabrafenib+trametinib for patients with resected stage III BRAF V600E-mutated melanoma [I, A; ESCAT score: I-A].
- These treatments should be given within 12 weeks of complete resection [I, A].
- The use of adjuvant nivolumab+ipilimumab according to the dosing schedule utilised in the phase II IMMUNED trial may be an option for selected patients with resected stage IV melanoma [II, C; not EMA or FDA approved].
- The HR for RFS for nivolumab+ipilimumab versus placebo was 0.25 (97.5% CI 0.13–0.48, P < 0.0001) and for nivolumab versus placebo was 0.60 (97.5% CI 0.36–1.00, P = 0.024).
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