A Randomized Controlled Phase II Trial With Intradermal IMO-2125 in Pathological Tumor Stage (p) T3-4 cN0M0 Melanoma
About this study
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
- Condition
- Malignant Melanoma
- Tested
- Tilsotolimod, Saline (0.9% sodium chloride)
- Sponsor
- A.J.M. van den Eertwegh
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 8
- Minimum age: 18 years
- Study condition: Malignant Melanoma
- 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 7
- 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
Where
1 site, 1 recruiting
VU Medical Centere
Amsterdam, Netherlands
Contact
-
Jessica CL Notohardjo, MD
+3120 4444881 intrim@vumc.nl
Potential match only. Final eligibility is determined by the study team.