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Study of IO102-IO103 and Pembrolizumab for Patients with Advanced Melanoma

Verified siteRegistered drugNo 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 called melanoma, specifically in cases where the cancer is advanced and cannot be removed by surgery. The study is investigating the effectiveness of a new treatment combination. The treatment involves two medications: IO102-IO103 and pembrolizumab. Pembrolizumab is already used in treating melanoma, while IO102-IO103 is being tested to see if it can improve outcomes when used together with pembrolizumab.

The purpose of the study is to compare the combination of IO102-IO103 and pembrolizumab against pembrolizumab alone. Participants in the study will receive either the combination treatment or pembrolizumab by itself. The study will monitor how long patients live without the cancer getting worse, which is known as progression-free survival. The trial will also look at other outcomes, such as the overall response rate, which measures how many patients experience a reduction in cancer size, and overall survival, which tracks how long patients live after starting the treatment.

Participants will be randomly assigned to one of the two treatment groups and will receive their treatment through injections. The study will continue for a period of up to 24 months, during which time patients will be regularly monitored to assess the effectiveness and safety of the treatments. This trial aims to provide valuable information on whether the new combination treatment can offer better results for patients with advanced 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.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of advanced melanoma and no prior systemic treatment for this condition.

    A biopsy and blood samples are collected for biomarker assessments.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups: one receiving pembrolizumab alone, and the other receiving a combination of IO102-IO103 and pembrolizumab.

  3. Step 3

    Treatment administration

    For those receiving pembrolizumab alone, the medication is administered as an intravenous infusion.

    For those receiving the combination treatment, pembrolizumab is administered intravenously, and IO102-IO103 is given as a subcutaneous injection.

    The specific dosage and frequency of administration are determined by the study protocol.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess the response to treatment and any side effects.

    Progression-free survival (PFS) is evaluated, which measures the time until the disease progresses or the patient passes away.

  5. Step 5

    End of treatment

    The treatment continues until disease progression, unacceptable side effects, or other criteria specified in the study protocol are met.

    Final assessments are conducted to evaluate the overall response rate and overall survival.

Who can join the trial?

8 criteria

  • The patient must have a type of skin cancer called melanoma that is either not treatable with surgery or has spread to other parts of the body.
  • The patient should not have received any previous treatment for this type of cancer, except in certain cases where previous treatments were given more than 6 months ago and did not result in a relapse during or shortly after treatment.
  • The patient must have a performance status score of 0 or 1, which means they are fully active or have some symptoms but can still carry out light work.
  • The patient should have a life expectancy of more than 24 weeks, as assessed by the doctor.
  • The patient must have at least one tumor that can be measured to see how the cancer responds to treatment.
  • The patient needs to provide a sample of their tumor tissue and blood for testing. This can be a recent sample or a new one taken during the screening process.
  • Both men and women can participate in the study.
  • The study includes adults and older adults.

Who cannot join the trial?

10 criteria

  • Patients who have already received treatment for their melanoma.
  • Patients whose melanoma can be surgically removed.
  • Patients who do not have melanoma that has spread to other parts of the body (metastatic melanoma).
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to give informed consent or are part of a vulnerable population.
  • Patients who have other medical conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial.
  • Patients who have allergies to the study medications.
  • Patients who have had a recent major surgery.
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Investigated drugs

  • IO102-IO103

    is an investigational therapy being studied for its potential to treat advanced melanoma. It is used in combination with another medication to see if it can improve outcomes for patients with this type of skin cancer. The goal is to determine if this combination can help patients live longer without their disease getting worse.

  • Pembrolizumab

    is a medication that helps the immune system fight cancer cells. It is already used to treat various types of cancer, including melanoma. In this trial, it is being used both alone and in combination with IO102-IO103 to see if the combination offers any additional benefits for patients with advanced melanoma.

What is already known about the treatment

  • IO102-IO103

    This medication is administered through injection and is currently being studied in clinical trials for its effectiveness in treating advanced melanoma that has not been treated before, cannot be surgically removed, or has spread to other parts of the body. It is being tested in combination with pembrolizumab to see if it improves progression-free survival compared to pembrolizumab alone. IO102-IO103 works by targeting specific proteins on cancer cells, helping the immune system recognize and attack these cells more effectively. It is classified as an immunotherapy agent.

  • Pembrolizumab

    This medication is given as an intravenous infusion and is already approved for use in various cancers, including melanoma. It is being used in clinical trials to assess its effectiveness when combined with IO102-IO103 for treating advanced melanoma. Pembrolizumab works by blocking a protein called PD-1 on immune cells, which helps the immune system attack cancer cells more effectively. It belongs to a class of drugs known as immune checkpoint inhibitors.

Investigated diseases

Melanoma – Melanoma is a type of skin cancer that develops from the pigment-producing cells known as melanocytes. It is characterized by the uncontrolled growth of these cells, often appearing as a new or changing mole on the skin. Melanoma can occur on any skin surface, but it is more common in areas exposed to the sun. If not detected early, melanoma can spread to other parts of the body, including lymph nodes and internal organs. The progression of melanoma is typically categorized by stages, which describe the extent of the disease's spread. Early detection and monitoring of skin changes are crucial in managing the progression of melanoma.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511996-13-00Protocol codeIOB-013/KN-D18Estimated enrolment407 patientsSponsorIo Biotech ApS

sourced from the EU Clinical Trials Register and site verification

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