RecruitingPhase 2NCT04126876

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

Sponsor

A.J.M. van den Eertwegh

Enrollment

214 participants

Start Date

Jan 22, 2020

Study Type

INTERVENTIONAL

Conditions

Malignant Melanoma

Summary

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called IMO-2125, injected into the skin, to see if it can help the immune system fight melanoma (a type of skin cancer) in people who are about to have surgery. **You may be eligible if...** - You are 18 or older - You have been diagnosed with primary melanoma of the skin with a tumor depth greater than 2 mm - You are scheduled for re-excision surgery and a sentinel lymph node biopsy - Your general health status is good (WHO performance status 0 or 1) - You agree to use effective contraception during and for 90 days after treatment **You may NOT be eligible if...** - You have a known allergy to any ingredient in IMO-2125 - You have an active autoimmune disease requiring medication - Your cancer has already spread to nearby lymph nodes or distant areas - You have a non-skin melanoma - You have another active cancer - You are pregnant or breastfeeding - You have an active infection requiring antibiotics Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTilsotolimod

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).

DRUGSaline (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).