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
Parallel
Tilsotolimod
DrugIntradermal, single injection of 1 ml (8 mg) Tilsotolimod (IMO-2125) at the primary melanoma excision site, one week prior to sentinel node biopsy (SNB).
Saline (0.9% sodium chloride)
DrugIntradermal, single injection of 1 ml plain saline (0.9% sodium chloride) at the primary melanoma excision site, one week prior to sentinel node biopsy (SNB).
The rate of tumor positive sentinal lymph node (SLN)
The rate of tumor positive sentinal lymph node (SLN)
Immune response in the SLN and peripheral blood
Frequency and activation state of lymph node resident (LNR) conventional dendritic cells (DC) and melanoma antigen-specific T cell responses in the SLN and peripheral blood.
Recurrence free survival (RFS)
The length of time from intradermal injection of Tilsotolimod (IMO-2125) to first documentation of recurrence.
Overall survival
The length of time from intradermal injection of Tilsotolimod (IMO-2125) to death from any cause.
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A.J.M. van den Eertwegh
Lead sponsor
Amsterdam UMC, location VUmc
Sponsor institution
Idera Pharmaceuticals, Inc.
Collaborator
