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Study of IO102-IO103 and Pembrolizumab for Patients with Resectable Melanoma and Head and Neck Squamous Cell Carcinoma

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 the effects of a treatment for certain types of cancer, specifically melanoma and squamous cell carcinoma of the head and neck. The treatment being tested involves two medications: pembrolizumab, also known by its brand name Keytruda, and a combination of substances called IO102-IO103. Pembrolizumab is given as an infusion into a vein, while IO102-IO103 is administered as an injection under the skin.

The purpose of the study is to explore how effective this combination treatment is when given before and after surgery in patients with tumors that can be surgically removed. Participants in the study will receive the treatment over a period of time, and their response to the treatment will be monitored. The study aims to see if the treatment can reduce the amount of cancer present in the body before surgery and improve outcomes after surgery.

Throughout the study, participants will receive regular check-ups to monitor their health and the effects of the treatment. The study will also look at the safety of the treatment by tracking any side effects that may occur. The goal is to gather information that could help improve treatment options for patients with these types of cancer in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, the patient provides written informed consent, confirming understanding and agreement to participate in the study.

    The patient must be at least 18 years old and meet specific health criteria, including having a measurable disease and adequate organ function.

  2. Step 2

    Initial assessment

    The patient undergoes an initial assessment to confirm eligibility, which includes providing a tumor tissue sample and undergoing various health evaluations.

    Women of childbearing potential must have a negative pregnancy test within 72 hours before receiving the first dose of trial medication.

  3. Step 3

    Neoadjuvant treatment

    The patient receives a combination of pembrolizumab and IO102-IO103 as part of the neoadjuvant treatment phase.

    Pembrolizumab is administered as an intravenous infusion, while IO102-IO103 is given as a subcutaneous injection.

    The specific dosage and frequency of administration are determined by the trial protocol and the patient's health status.

  4. Step 4

    Surgery

    Following the neoadjuvant treatment, the patient undergoes surgery to remove the tumor.

    The effectiveness of the treatment is assessed by examining the tumor tissue removed during surgery.

  5. Step 5

    Post-surgery treatment

    After surgery, the patient continues to receive IO102-IO103 and pembrolizumab as part of the post-surgery treatment phase.

    The treatment aims to prevent the recurrence of the disease and is administered according to the trial protocol.

  6. Step 6

    Follow-up and monitoring

    The patient attends regular follow-up appointments to monitor health status and assess the long-term effects of the treatment.

    The trial includes safety assessments to track any adverse events or side effects experienced during the study.

Who can join the trial?

17 criteria

  • Must have a disease that can be measured based on specific criteria used by doctors to evaluate tumors.
  • If you are HIV-positive, you must be on medication for HIV and have a well-controlled infection. This means:
    • Your CD4+ T-cell count should be more than 350 cells/mm3 at the time of screening.
    • Your HIV viral load should be very low, below 50 copies/mL, for at least 12 weeks before starting the trial medication.
    • You should have been on a stable HIV medication regimen for at least 4 weeks before starting the trial medication.
    • If you have hepatitis B, you must have been on antiviral therapy for at least 4 weeks and have an undetectable viral load before starting the trial.
    • If you have a history of hepatitis C, your viral load must be undetectable at screening.
    • For melanoma patients:
      • You must have a confirmed diagnosis of stage III melanoma that can be surgically removed.
      • You may have primary melanoma with regional lymph node metastases, recurrent melanoma in lymph nodes, or relapsed resectable stage III melanoma.
      • For squamous cell carcinoma of the head and neck (SCCHN) patients:
        • You must have a newly diagnosed and confirmed SCCHN that is advanced but can be surgically removed.
        • You must be a candidate for surgery with the goal of curing the disease.
        • You or your legal representative must provide written consent to participate in the trial.
        • You must be at least 18 years old on the day you sign the consent form.
        • You must provide a tumor tissue sample that is no more than 3 months old or a new biopsy of a tumor that has not been previously treated with radiation.
        • You must have an ECOG performance status of 0 or 1, which means you are fully active or have some symptoms but can carry out light work.
        • You must have adequate organ function, meaning your organs are working well enough to participate in the trial.
        • If you are a woman who can become pregnant, you must have a negative pregnancy test within 72 hours before receiving the first dose of trial medication.
        • If you are a woman who can become pregnant, you must agree to use highly effective birth control or abstain from heterosexual activity during the trial and for at least 120 days after the last dose of trial medication.

Who cannot join the trial?

7 criteria

  • Patients who have a different type of cancer than melanoma or squamous cell carcinoma of the head and neck cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not able to undergo surgery to remove the tumor cannot participate.
  • Patients who have received certain treatments for their cancer before the study may not be eligible.
  • Patients with certain medical conditions that could interfere with the study treatment may not be eligible.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are unable to follow the study procedures or attend study visits may not be eligible.
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Investigated drugs

  • IO102-IO103

    is a type of treatment that helps the body's immune system recognize and attack cancer cells. It is designed to work by targeting specific proteins on the surface of cancer cells, making it easier for the immune system to find and destroy them. This therapy is used before surgery to shrink the tumor and make it easier to remove.

  • Pembrolizumab

    is a medication that helps the immune system fight cancer. It works by blocking a protein that stops the immune system from attacking cancer cells. By blocking this protein, pembrolizumab allows the immune system to better detect and kill cancer cells. It is used in combination with other treatments to improve the chances of removing the tumor completely during surgery.

What is already known about the treatment

  • IO102-IO103

    This medication is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating certain types of cancer, specifically melanoma and squamous cell carcinoma of the head and neck. It is not yet widely used in standard medical practice, as it is still under investigation. The main purpose of IO102-IO103 is to help the immune system recognize and attack cancer cells more effectively. It works by targeting specific proteins on the surface of cancer cells, making them more visible to the immune system. IO102-IO103 is classified as an immunotherapy, which is a type of treatment that uses the body's own immune system to fight cancer.

  • Pembrolizumab

    This medication is given as an intravenous infusion and is already approved for use in treating various types of cancer, including melanoma and squamous cell carcinoma of the head and neck. It is well-documented in medical literature and is used to help the immune system fight cancer by blocking a specific protein called PD-1, which can prevent the immune system from attacking cancer cells. By inhibiting this protein, pembrolizumab allows the immune system to better recognize and destroy cancer cells. Pembrolizumab is also classified as an immunotherapy, which enhances the body's natural defenses to combat 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 often begins as a mole that changes in size, shape, or color, but it can also appear on skin that looks normal. As melanoma progresses, it can invade deeper layers of the skin and spread to other parts of the body through the lymphatic system or bloodstream. The disease can develop on any skin surface, but it is more common on the trunk in men and the legs in women. Early stages may be asymptomatic, but as it advances, it can cause itching, tenderness, or bleeding.

  • Squamous Cell Carcinoma of the Head and Neck

    Squamous cell carcinoma of the head and neck is a cancer that arises from the squamous cells lining the moist surfaces inside the head and neck, such as the mouth, nose, and throat. It typically begins as a flat, scaly lesion that can become a sore or ulcer that does not heal. As the carcinoma progresses, it can invade nearby tissues and spread to lymph nodes in the neck. The disease may cause symptoms like a persistent sore throat, difficulty swallowing, or changes in voice. It can also lead to the formation of lumps or masses in the neck. Advanced stages may involve more extensive tissue invasion and metastasis to distant organs.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502787-20-00Protocol codeIOB‑032/PN‑E40Estimated enrolment90 patientsSponsorIo Biotech ApS

sourced from the EU Clinical Trials Register and site verification

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