RECRUITINGPhase 2INTERVENTIONAL

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

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

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 18 years or older - diagnosed by tissue sample (biopsy-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 willing to sign a consent form Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Tilsotolimod

Intradermal, single injection of 1 ml (8 mg) Tilsotolimod (IMO-2125) at the primary melanoma excision site, one week prior to sentinel node biopsy (SNB).

DRUG

Saline (0.9% sodium chloride)

Intradermal, single injection of 1 ml plain saline (0.9% sodium chloride) at the primary melanoma excision site, one week prior to sentinel node biopsy (SNB).

Locations (1)

VU Medical Centere

Amsterdam, Netherlands