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Tilsotolimod Sodium

A new clinical trial is investigating the potential of Tilsotolimod Sodium (IMO-2125) in treating advanced melanoma. This study focuses on patients with pT3-4 cN0M0 melanoma, examining how intradermal administration of the drug might affect tumor presence in sentinel lymph nodes and impact overall patient outcomes.

Table of Contents

What is Tilsotolimod Sodium?

Tilsotolimod Sodium, also known as IMO-2125, is an investigational drug being studied for the treatment of advanced melanoma[1]. It is a type of medication called a nucleic acid, which means it’s made up of the same building blocks as our DNA[1]. This drug is currently being tested to see if it can help patients with a specific type of advanced skin cancer.

Medical Condition: Advanced Melanoma

The specific condition being targeted in this study is pT3-4 cN0M0 Melanoma[1]. Let’s break down what this means:

  • Melanoma: This is a type of skin cancer that develops in the cells that produce melanin, the pigment that gives skin its color.
  • pT3-4: This refers to the thickness of the tumor. T3 and T4 tumors are considered thick, which often indicates a more advanced stage of melanoma.
  • cN0: This means that there are no detectable cancer cells in the nearby lymph nodes.
  • M0: This indicates that the cancer has not spread to distant parts of the body.

How Tilsotolimod Sodium Works

Tilsotolimod Sodium is designed to stimulate the body’s immune system to fight against cancer cells[1]. It works by:

  1. Increasing the number and activation of certain immune cells called dendritic cells in the lymph nodes and blood.
  2. Enhancing the activity of T cells that can recognize and attack melanoma cells.
By boosting these aspects of the immune system, the drug aims to improve the body’s natural ability to fight the cancer.

Current Clinical Trial

A clinical trial called the “Intrim 1 study” is currently underway to test the effectiveness of Tilsotolimod Sodium[1]. This is a Phase II trial, which means it’s designed to gather more information about the drug’s effectiveness and safety. The main goal of this trial is to see if Tilsotolimod Sodium can reduce the number of patients who have cancer cells in their sentinel lymph nodes (SLN). The sentinel lymph node is the first lymph node where cancer cells are likely to spread from the primary tumor.

Eligibility Criteria

To participate in this clinical trial, patients must meet certain criteria[1]. Some key eligibility requirements include:

  • Being 18 years of age or older
  • Having a confirmed diagnosis of primary malignant melanoma with a tumor depth greater than 2.0 mm
  • Having a good overall health status (WHO Performance Status ≤1)
There are also several conditions that would exclude a person from participating, such as having active autoimmune disease or other types of cancer.

Administration and Dosage

Tilsotolimod Sodium is administered as a solution for injection[1]. In this trial, it’s given through an intradermal injection, which means it’s injected directly into the skin. The maximum daily dose being tested is 8 mg[1]. The treatment is given locally, near the site of the melanoma, with the aim of affecting the nearby lymph nodes.

Potential Benefits

While the full benefits of Tilsotolimod Sodium are still being studied, researchers hope to see several positive outcomes[1]:

  • Reduced presence of cancer cells in sentinel lymph nodes
  • Improved immune response against melanoma cells
  • Better recurrence-free survival (RFS) and overall survival (OS) rates for patients with advanced melanoma
The trial will be monitoring these outcomes for up to 10 years after treatment to understand the long-term effects of the drug.

Aspect Details
Drug Name Tilsotolimod Sodium (IMO-2125)
Trial Phase Phase II
Condition pT3-4 cN0M0 Melanoma
Administration Intradermal injection
Dosage 8 mg maximum daily dose
Primary Endpoint Rate of tumor-positive sentinel lymph nodes seven days after treatment
Secondary Endpoints Immune cell responses, Recurrence-Free Survival, Overall Survival
Follow-up Duration Up to 10 years after sentinel node biopsy

FAQ

  • What is Tilsotolimod Sodium? Tilsotolimod Sodium, also known as IMO-2125, is a drug being studied for its potential in treating advanced melanoma. It is administered through intradermal injection, which means it's injected directly into the skin.
  • What type of melanoma is being studied in this trial? This trial is focusing on patients with pT3-4 cN0M0 melanoma. This means the primary tumor is relatively thick (T3-4), but there are no detectable lymph node metastases (N0) or distant metastases (M0) at the time of diagnosis.
  • What is the main goal of this clinical trial? The main objective is to investigate if local administration of IMO-2125 (Tilsotolimod) results in lower rates of tumor-positive sentinel lymph nodes (SLN) in patients with pT3-4 cN0M0 melanoma.
  • How long will patients be followed in this study? Patients will be followed for recurrence-free survival (RFS) and overall survival (OS) at various time points, including 18 months, 24 months, 36 months, 5 years, and up to 10 years after the sentinel node biopsy (SNB).
  • Who is eligible to participate in this trial? Eligible participants must be 18 years or older, have a confirmed primary malignant melanoma with a tumor depth greater than 2.0 mm, and meet other specific health criteria. However, patients with known hypersensitivity to oligodeoxynucleotides, active autoimmune diseases, or other specific health conditions are excluded.

Ongoing Clinical Trials on Tilsotolimod Sodium

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

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

Glossary

  • Melanoma: A type of skin cancer that develops in the cells (melanocytes) that produce melanin, the pigment that gives your skin its color.
  • Sentinel Lymph Node (SLN): The first lymph node to which cancer cells are most likely to spread from a primary tumor.
  • Intradermal: Relating to or within the layers of the skin.
  • pT3-4 cN0M0: A staging classification for melanoma where 'pT3-4' indicates the thickness of the primary tumor, 'cN0' means no clinical evidence of lymph node involvement, and 'M0' means no distant metastases.
  • Recurrence-Free Survival (RFS): The length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer.
  • Overall Survival (OS): The length of time from either the date of diagnosis or the start of treatment for a disease that patients diagnosed with the disease are still alive.
  • Sentinel Node Biopsy (SNB): A surgical procedure used to determine if cancer has spread beyond a primary tumor into the lymphatic system.
  • WHO Performance Status: A scale used to assess how a patient's disease is progressing, how it affects daily living abilities, and determine appropriate treatment and prognosis.
  • Breslow tumor depth: A measurement of how deeply tumor cells have invaded the skin, used in melanoma staging.
  • Oligodeoxynucleotide: A short segment of synthetic DNA or RNA molecules that can be used in research or as therapeutic agents.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effects-of-intradermal-imo-2125-tilsotolimod-for-patients-with-advanced-melanoma/