Currently, there is no widely used adjuvant treatment available to improve survival after surgical excision of a primary melanoma. In a previous study, loco-regional and systemic immune stimulations, as well as favourable clinical outcomes in terms of sentinel lymph node (SLN) tumor status and recurrence-free survival (RFS) in patients with clinical stage I-II melanoma who received a low dose of toll-like receptor 9 (TLR-9) CPG7909 (CpG-B ODN) intradermally at the excision site of the primary tumor prior to SLN biopsy (SNB) were described. In this phase II trial the investigators had investigated the clinical activity of a next-generation CpG-ODN, IMO-2125, and it's ability to induce loco-regional and systemic immune stimulation in pT3-4 cN0M0 melanoma patients who are scheduled to undergo a combined re-excision and SNB is
18 years or older
Histologically confirmed primary malignant melanoma cutis with a Breslow tumor depth >2.0 mm
Scheduled to undergo a combines re-excision and sentinel node biopsy (SNB)
World Health Organization (WHO) Performance Status ≤1
Known hypersensitivity to any oligodeoxynucleotide
Active auto-immune disease requiring disease-modifying therapy at the tumr of screening
Pathologically confirmed loco-regional or distant metastasis
Non-skin melanoma
A.J.M. van den Eertwegh
Lead sponsor
Amsterdam UMC, location VUmc
Sponsor institution
Idera Pharmaceuticals, Inc.
Collaborator