Tests tilsotolimod after surgery for thicker melanoma
Tests tilsotolimod injected into skin near melanoma in adults with thicker melanoma.
Plain-language title generated from the registry record
Registry title: A Randomized Controlled Phase II Trial With Intradermal IMO-2125 in Pathological Tumor Stage (p) T3-4 cN0M0 Melanoma
Key facts
- Where
- Amsterdam, NetherlandsSee the site
- Phase
- Phase 2
Where in Netherlands
- VU Medical CentereAmsterdam, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- A.J.M. van den Eertwegh
- Trial code
- NCT04126876
- Record updated
- 15 April 2021
- Original description
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 isRead full original descriptionShow less
A Randomized Controlled Phase II Clinical Trial With Intradermal IMO-2125 (Tilsotolimod) in pT3-4 cN0M0 Melanoma
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
Inclusion: 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: Known hypersensitivity to any oligodeoxynucleotide; Active auto-immune disease requiring disease-modifying therapy at the tumr of screening; Patients with another primary malignancy (some exceptions); Active systemic infections requiring antibiotics; Pathologically confirmed loco-regional or distant metastasis; Non-skin melanoma; Women who are pregnant or breast-feeding.