Not recruiting

Study on the Effects of Intradermal IMO-2125 (Tilsotolimod) for Patients with Advanced Melanoma

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of skin cancer known as melanoma. Specifically, it involves patients with a certain stage of melanoma called pT3-4 cN0M0 melanoma. The treatment being tested in this study is called IMO-2125, also known as tilsotolimod sodium. This medication is given as a solution for injection directly into the skin, a method known as intradermal injection.

The purpose of the study is to see if using IMO-2125 can reduce the number of cancerous cells found in a specific type of lymph node, called the sentinel lymph node (SLN), in patients with this stage of melanoma. The study will compare the effects of IMO-2125 with a placebo to determine its effectiveness. Participants will receive the treatment and then be monitored for changes in their condition, including the presence of cancer cells in the SLN, over a period of time.

Throughout the study, researchers will also observe other factors, such as the activity of certain immune cells in the lymph nodes and blood, and track the participants' health over several years. This includes looking at how long patients remain free of cancer and their overall survival rates at different time points after the treatment. The study aims to provide valuable information on whether IMO-2125 can be an effective treatment option for this type of melanoma.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient must sign an informed consent form, indicating willingness to participate and comply with the study protocol.
The patient must be at least 18 years old and have a confirmed diagnosis of primary malignant melanoma with a Breslow tumor depth greater than 2.0 mm.
Step 2
Initial assessment
The patient will undergo an initial assessment to confirm eligibility, including a review of medical history and a physical examination.
Women of childbearing potential and fertile men must agree to use effective contraceptive methods from the screening phase until at least 90 days after the administration of the study medication.
Step 3
Treatment administration
The patient will receive an intradermal injection of the study medication, IMO-2125 (tilsotolimod sodium), which is a solution for injection.
The purpose of this treatment is to investigate if local administration results in lower rates of tumor-positive sentinel lymph nodes.
Step 4
Follow-up and monitoring
Seven days after the treatment, the patient will be assessed for the rate of tumor-positive sentinel lymph nodes.
The patient will also be monitored for the frequency and activation state of specific immune cells in the lymph nodes and blood.
Step 5
Long-term follow-up
The patient will have regular follow-up visits to assess recurrence-free survival (RFS) and overall survival (OS) at 18 months, 24 months, 36 months, 5 years, and 10 years after the sentinel node biopsy.
These follow-up visits are crucial for monitoring the long-term effects of the treatment.

Who can join the trial?

5 criteria

Patients must be willing and able to sign the informed consent and follow the study rules.
Must be at least 18 years old.
WHO Performance Status ≤1: This means the patient should be fully active or have some restrictions in physically strenuous activity but be able to carry out light work.
Must have a confirmed diagnosis of primary malignant melanoma of the skin with a Breslow tumor depth greater than 2.0 mm. Breslow depth measures how deep the melanoma has grown into the skin.
Women who can have children and men who are fertile must agree to use effective birth control methods from the start of the study until at least 90 days after receiving the study treatment, IMO-2125.

Who cannot join the trial?

5 criteria

Patients with any other type of cancer besides pT3-4 cN0M0 melanoma cannot participate. Melanoma is a type of skin cancer, and pT3-4 cN0M0 refers to a specific stage of this cancer.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population, such as those who cannot give consent or are unable to understand the study, cannot participate.
Patients who are not able to follow the study procedures or attend the required visits cannot participate.
Patients with any medical condition that the study doctors believe would make it unsafe for them to participate cannot join the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Amsterdam UMC
Amsterdam, The Netherlands
Verified
Diakonessenhuis Stichting
Utrecht, The Netherlands
Verified
Spaarne Gasthuis
Hoofddorp, The Netherlands

Trial locations

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Investigated drugs

IMO-2125 (Tilsotolimod) is a medication being tested in this clinical trial. It is given through an injection directly into the skin. The purpose of this medication is to help the body's immune system fight against melanoma, a type of skin cancer. By injecting it into the skin, the medication aims to activate the immune system locally, which might help reduce the spread of cancer to nearby lymph nodes. This trial is specifically looking at whether this approach can lower the chances of finding cancer in the lymph nodes of patients with a certain stage of melanoma.

Tilsotolimod Sodium

What is already known about the treatment

IMO-2125 (Tilsotolimod) – This medication is administered through an injection directly into the skin, known as intradermal administration. It is currently being studied in clinical trials for its potential use in treating advanced melanoma, specifically in patients with a type of skin cancer called pT3-4 cN0M0 melanoma. The main goal of using IMO-2125 is to see if it can reduce the spread of cancer to nearby lymph nodes. At the molecular level, it works by stimulating the immune system to attack cancer cells. It is classified as an immune response modifier, which means it helps the body's natural defenses fight the cancer.

Investigated diseases

Melanoma – Melanoma is a type of skin cancer that originates in the melanocytes, the cells responsible for producing melanin, the pigment that gives skin its color. It typically begins as a mole or a dark spot on the skin that changes in size, shape, or color. As melanoma progresses, it can invade deeper layers of the skin and spread to other parts of the body, including lymph nodes and internal organs. The disease is categorized by stages, with pT3-4 indicating a tumor that has grown deeper into the skin but has not yet spread to lymph nodes or distant sites. The progression of melanoma is influenced by factors such as the thickness of the tumor and the presence of ulceration. Early detection and monitoring of changes in skin lesions are crucial in managing the disease's progression.