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Study on IO102-IO103 and Pembrolizumab for Patients with Metastatic Lung, Head and Neck, or Bladder Cancer

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 effectiveness and safety of a new treatment combination for certain types of cancer. The diseases being studied are Metastatic Non-Small Cell Lung Cancer (NSCLC), Squamous Cell Carcinoma of the Head and Neck (SCCHN), and Metastatic Urothelial Bladder Cancer (mUBC). The treatment being tested combines two medications: IO102-IO103 and Pembrolizumab, which is also known by its brand name, Keytruda. IO102-IO103 is a type of protein-based treatment, and Pembrolizumab is a medication that helps the immune system fight cancer.

The purpose of this study is to see how well this combination works as a first-line treatment, meaning it is the first treatment given for these cancers. The study will involve patients receiving the treatment through injections. IO102-IO103 is given as a subcutaneous injection, which means it is injected under the skin, while Pembrolizumab is given as an intravenous infusion, meaning it is delivered directly into a vein. The study will last for up to 24 months, during which the safety and effectiveness of the treatment will be closely monitored.

Participants in the study will be those who have not received prior systemic treatment for their metastatic disease. The study aims to determine if this combination can provide a significant clinical benefit for patients with these specific types of cancer. The trial will also assess various outcomes, such as how long patients live without the disease getting worse and the overall response to the treatment. The results will help in understanding if this combination can be a viable treatment option for these cancers.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and enrollment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.

    Eligibility criteria include having a confirmed diagnosis of one of the specified cancers, adequate organ function, and measurable disease. A biopsy may be required to confirm the diagnosis.

  2. Step 2

    Treatment initiation

    The treatment involves the administration of two medications: IO102-IO103 and pembrolizumab.

    IO102-IO103 is given as a subcutaneous injection. The specific dosage and frequency are determined by the study protocol.

    Pembrolizumab is administered as an intravenous infusion. The dosage is 25 mg/mL, and the frequency is determined by the study protocol.

  3. Step 3

    Ongoing treatment and monitoring

    Regular monitoring is conducted to assess the response to treatment and any side effects. This includes physical examinations, blood tests, and imaging studies.

    The primary goal is to evaluate the effectiveness of the treatment in controlling the cancer and to monitor for any adverse reactions.

  4. Step 4

    Completion of treatment

    The treatment continues until the study's end date or until it is determined that the treatment is no longer beneficial.

    Upon completion, a final assessment is conducted to evaluate the overall response to the treatment and any long-term effects.

Who can join the trial?

14 criteria

  • Patients must have a confirmed diagnosis of one of the following cancers: Metastatic Non-Small Cell Lung Cancer (NSCLC), Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN), or Metastatic Urothelial Bladder Cancer (mUBC).
  • Patients with NSCLC should not have received prior treatment for their metastatic disease and should not have certain genetic changes for which there are approved treatments.
  • Patients with SCCHN should not have received prior systemic therapy for their recurrent or metastatic cancer, except if it was completed more than 6 months ago as part of treatment for locally advanced disease. The cancer should be considered incurable by local treatments.
  • Patients with mUBC should not have received prior therapy and should not be eligible for any platinum-containing chemotherapy.
  • Patients must have adequate organ function, which includes specific requirements for blood counts, kidney function, liver function, and blood clotting ability.
  • Patients with a history of hepatitis B or C are eligible if they have undetectable viral loads and have completed appropriate antiviral therapy.
  • Patients must have specific levels of a protein called PD-L1 in their cancer cells, which will be confirmed before joining the study.
  • Female participants must not be pregnant or breastfeeding and must agree to use contraception if they are of childbearing potential.
  • Participants must provide written informed consent to join the trial.
  • Participants must be at least 18 years old.
  • Participants must have measurable disease, meaning the cancer can be measured using specific criteria.
  • Participants must provide a sample of their tumor tissue for analysis.
  • Participants must have an ECOG performance status of 0 to 1, which indicates they are fully active or have some symptoms but do not require bed rest.
  • If participants have had major surgery, they must have recovered from any side effects or complications before starting the trial treatment.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer than those specified in the study.
  • Patients who are not within the age range specified for the study.
  • Patients who are not able to give informed consent or understand the study requirements.
  • Patients who have a medical condition that could interfere with the study treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have an allergy to the study medication or its components.
  • Patients who have a serious infection or illness that could affect the study results.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who are taking medications that could interfere with the study treatment.
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Investigated drugs

  • IO102-IO103

    is an investigational therapy being studied for its potential to treat certain types of cancer. It is being tested in combination with another medication to see if it can help improve outcomes for patients with specific types of metastatic cancer, including non-small cell lung cancer, squamous cell carcinoma of the head and neck, and urothelial bladder cancer.

  • Pembrolizumab

    is a medication used in cancer treatment that helps the immune system recognize and attack cancer cells. It is commonly used as a first-line treatment for various types of cancer and is being studied in combination with IO102-IO103 to evaluate its effectiveness in treating metastatic cancers.

What is already known about the treatment

  • Pembrolizumab

    This medication is administered intravenously and is currently used in clinical settings for various types of cancer. It is widely recognized in medical literature as an effective treatment for certain cancers, including metastatic non-small cell lung cancer, metastatic urothelial bladder cancer, and metastatic squamous cell carcinoma of the head and neck. Pembrolizumab works by blocking a specific protein on immune cells, known as PD-1, which helps the immune system attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor, a type of immunotherapy that enhances the body's natural defenses to fight cancer.

  • IO102-IO103

    This medication is administered in combination with pembrolizumab and is currently under investigation in clinical trials for its safety and efficacy. It is being studied for its potential use in treating metastatic non-small cell lung cancer, metastatic urothelial bladder cancer, and metastatic squamous cell carcinoma of the head and neck. IO102-IO103 is designed to target specific proteins involved in cancer cell growth, aiming to enhance the immune response against tumors. It falls under the category of cancer immunotherapies, which are treatments that stimulate the immune system to recognize and destroy cancer cells.

Investigated diseases

  • Metastatic Urothelial Bladder Cancer

    This is a type of cancer that begins in the cells lining the bladder and has spread to other parts of the body. It often progresses by invading nearby tissues and can spread to distant organs such as the liver, lungs, and bones. The disease may cause symptoms like blood in the urine, frequent urination, and pain during urination. As it advances, it can lead to more severe symptoms depending on the organs affected by metastasis.

  • Metastatic Non-Small Cell Lung Cancer

    This is a form of lung cancer that has spread beyond the lungs to other parts of the body. It typically originates in the tissues of the lungs and can metastasize to areas such as the brain, bones, and liver. The progression of the disease can lead to symptoms like persistent cough, chest pain, and difficulty breathing. As it spreads, it may cause additional symptoms related to the specific organs involved.

  • Metastatic Squamous Cell Carcinoma of Head and Neck

    This cancer starts in the squamous cells lining the surfaces of the head and neck region and has spread to other body parts. It often progresses by invading nearby structures such as lymph nodes and can metastasize to distant sites like the lungs. Symptoms may include a persistent sore throat, difficulty swallowing, and changes in voice. As the disease advances, it can lead to more complex symptoms depending on the areas affected by metastasis.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511561-10-00Protocol codeIOB-022/KN-D38Estimated enrolment90 patientsSponsorIo Biotech ApS

sourced from the EU Clinical Trials Register and site verification

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