Table 1

Overview on neoadjuvant trials currently recruiting in melanoma

Identifier clinicaltrials.govTrial nameCompounds
NCT03698019A Study to Compare the Administration of Pembrolizumab After Surgery vs Administration Both Before and After Surgery for High-Risk MelanomaPembrolizumab (anti-PD-1)
NCT02977052Optimal Neo-adjuvant Combination Scheme of Ipilimumab and Nivolumab—PRADO extension cohortIpilimumab (anti-CTLA-4) + nivolumab (anti-PD-1)
NCT02519322Neoadjuvant and Adjuvant Checkpoint Blockade in Patients with Clinical Stage III or Oligometastatic Stage IV MelanomaNivolumab (anti-PD-1) ± ipilimumab (anti-CTLA-4) or ± relatlimab (anti-LAG-3)
NCT02858921Neoadjuvant Dabrafenib, Trametinib and/or Pembrolizumab in BRAF Mutant Resectable Stage III Melanoma—NeoTrioDabrafenib (BRAF inhibitor) + trametinib (MEK inhibitor) ± pembrolizumab (anti-PD-1)
NCT03554083Neoadjuvant Combination Targeted and Immunotherapy for Patients with High-Risk Stage III Melanoma—NeoACTIVATEVemurafenib (BRAF inhibitor) + cobimetinib (MEK inhibitor) ± atezoluzimab (anti-PD-L1)
NCT02668770Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients With Advanced Solid MalignanciesMGN1703 (TLR-9 agonist)+ipilimumab (anti-CTLA-4)
NCT03618641Neoadjuvant Phase II Study of TLR9 Agonist CMP-001 in Combination with Nivolumab in Stage IIIB/C/D Melanoma Patients With Clinically Apparent Lymph Node DiseaseCMP-001 (TLR-9 agonist) + nivolumab (anti-PD-1)
NCT04207086A Phase II Study of Neoadjuvant Pembrolizumab & Lenvatinib for Resectable Stage III Melanoma—Neo PeLeLenvatinib (TKI) + anti-PD-1
NCT04133948Multicenter Phase 1b Trial Testing the Neoadjuvant Combination of Domatinostat, Nivolumab and Ipilimumab in IFN-γ Signature-low and IFN-γ Signature-high RECIST 1.1-measurable Stage III Cutaneous or Unknown Primary Melanoma—DONIMIDomatinostat (HDACi) + anti-PD-1 ± anti-CTLA-4
  • BRAF, B-raf proto-oncogene serine/threonine kinase; CTLA-4, cytotoxic T lymphocyte antigen 4; HDACi, histone deacetylase inhibitor; IFN-γ, interferon-gamma; LAG-3, lymphocyte-activation gene 3; MEK, mitogen-activated protein kinase kinase; PD-1, programmed cell death protein 1; PD-L1, programmed death-ligand 1; TKI, tyrosine kinase inhibitor; TLR-9, toll-like receptor 9.