A Randomized Controlled Phase II Trial With Intradermal IMO-2125 in Pathological Tumor Stage (p) T3-4 cN0M0 Melanoma

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

Eligibility

Inclusion Criteria:

* 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
* Agreement to use effective contraceptive methods from screening until at least 90 days after the IMO-2125 administration
* Written informed consent

Exclusion Criteria:

* 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
* Patients with another primary malignancy (some exceptions)
* Active systemic infections requiring antibiotics
* Women who are pregnant or breast-feeding

Conditions2

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