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

Trial Details

NCT ID

NCT04126876

Phase

PHASE2

Sponsor

A.J.M. van den Eertwegh

Status

RECRUITING

Cancer Type

Melanoma

Interventions

• Tilsotolimod
• Saline (0.9% sodium chloride)

Locations (sample)

• Amsterdam, Netherlands|52.37403,4.88969

Key Eligibility 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

For full eligibility, visit ClinicalTrials.gov.

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