A Randomized Controlled Phase II Trial With Intradermal IMO-2125 in Pathological Tumor Stage (p) T3-4 cN0M0 Melanoma
Status:
Recruiting
Trial end date:
2031-11-01
Target enrollment:
Participant gender:
Summary
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