A Randomized Controlled Phase II Clinical Trial With Intradermal IMO-2125 (Tilsotolimod) in pT3-4 cN0M0 Melanoma

What this Trial Is About

Researchers are evaluating the immune-stimulating drug Tilsotolimod (IMO-2125) as a possible adjuvant treatment for patients with primary malignant melanoma of the skin at pathological tumor stages T3-4 without clinical lymph node or distant metastasis (cN0M0). The study aims to assess Tilsotolimod's ability to induce local and systemic immune responses and potentially improve outcomes after surgical removal of the melanoma and sentinel lymph node biopsy. This phase II randomized controlled trial builds on earlier findings that similar immune stimulation may reduce tumor spread and recurrence risk in early-stage melanoma. Participants will receive a single intradermal injection of either 8 mg Tilsotolimod or a saline placebo at the melanoma excision site one week before their scheduled combined re-excision and sentinel node biopsy. The study compares the effects of Tilsotolimod versus placebo on the immune environment in the sentinel lymph node and peripheral blood, as well as clinical outcomes over time. The treatment is administered once prior to surgery, and participants are followed for up to 10 years to measure recurrence-free survival and overall survival. During the trial, researchers will monitor the presence of tumor cells in the sentinel lymph node seven days after injection as the primary outcome. Secondary assessments include immune responses in the lymph node and blood, along with long-term follow-up evaluations of recurrence-free and overall survival at 5 and 10 years after sentinel node biopsy. Participants will undergo regular clinical visits and evaluations as part of the study, and safety will be closely monitored throughout the extended observation period.

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