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Study of Nivolumab and Ipilimumab for Patients with Type B3 Thymoma and Thymic Carcinoma After Chemotherapy

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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 immunotherapy in patients with type B3 thymoma and thymic carcinoma. These are types of cancers that occur in the thymus, a small organ in the upper chest. The study involves the use of two medications: Ipilimumab and Nivolumab. Both of these medications are given as an infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how well these medications work in patients whose cancer has returned or advanced after previous treatment with chemotherapy. Participants in the study will receive either Nivolumab alone or a combination of Nivolumab and Ipilimumab. The study will monitor the patients over a period of time to see how their cancer responds to the treatment and to assess the safety of the medications.

Throughout the study, patients will have regular check-ups and tests to track their health and the progress of their cancer. The study aims to provide valuable information on the effectiveness of these treatments for thymic cancers, which could help improve future treatment options for patients with these conditions.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the presence of type B3 thymoma or thymic carcinoma that has relapsed or advanced and is not suitable for curative treatment.

    Eligibility criteria include adequate renal, liver, and hematological function, as well as a negative pregnancy test for women of childbearing potential. Previous treatment with platinum-based chemotherapy is required.

  2. Step 2

    Treatment initiation

    Treatment begins with the administration of nivolumab or a combination of nivolumab and ipilimumab. Both medications are given intravenously.

    The specific dosage and frequency of administration are determined by the study protocol and the patient's condition.

  3. Step 3

    Treatment monitoring

    Regular monitoring is conducted to assess the patient's response to treatment. This includes imaging studies to evaluate disease progression according to RECIST 1.1 criteria.

    Safety assessments are performed to monitor any adverse effects, following the CTCAE v4.0 guidelines.

  4. Step 4

    Progress evaluation

    The primary goal is to assess the Progression Free Survival Rate at 6 months. This is evaluated through independent radiological review.

    Secondary evaluations include overall response rate, disease control rate, and overall survival.

  5. Step 5

    Continuation or conclusion

    Based on the evaluation results, the decision is made whether to continue treatment or conclude participation in the study.

    Patients may continue treatment after progression if deemed beneficial by the study investigators.

Who can join the trial?

14 criteria

  • The patient must have **relapsed or advanced thymoma B3** or **thymic carcinoma** that cannot be treated with surgery aimed at curing the disease.
  • The patient must have **adequate kidney function**, which means the kidneys are working well enough. This is measured by a test called **creatinine clearance**, which should be 50 mL/min or higher.
  • Women who can have children must have a **negative pregnancy test** within 72 hours before starting the study treatment.
  • Patients who can have children should use **effective birth control** during the study and for at least 5 months after the last treatment for women, and 7 months for men.
  • Female patients who are **breastfeeding** should stop nursing before starting the study treatment and should not breastfeed during the study and for at least 5 months after the last treatment.
  • The patient must provide **written informed consent**, which means they agree to participate in the study after being informed about it.
  • The patient must have had at least **one previous treatment with platinum-based chemotherapy** for advanced disease.
  • The patient must have **documented disease progression**, which means the disease has gotten worse, as shown by medical imaging tests.
  • The patient must have **measurable disease**, meaning the disease can be measured using medical imaging tests.
  • The patient must be at least **18 years old**.
  • The patient must have a **WHO Performance Status** of 0 to 2, which is a scale that measures how well a patient can perform daily activities.
  • The patient must have **FFPE tumor tissue** available for testing. This is a sample of the tumor that can be used to check for certain markers, like **PD-L1**.
  • The patient must have **adequate blood function**, meaning their blood counts are within a certain range. This includes having enough white blood cells, hemoglobin, and platelets.
  • The patient must have **adequate liver function**, meaning their liver is working well enough. This is measured by certain blood tests, including bilirubin, ALT, AST, and alkaline phosphatase levels.

Who cannot join the trial?

4 criteria

  • Patients with a type of cancer called type B3 thymoma or thymic carcinoma that cannot be treated with surgery aimed at curing the disease.
  • Patients who have not been previously treated with a type of cancer treatment called platinum-based chemotherapy.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Nivolumab

    is a type of immunotherapy used in this trial. It works by helping the immune system recognize and attack cancer cells. This medication is being tested to see if it can help control thymic carcinoma and type B3 thymoma in patients who have already received chemotherapy.

  • Ipilimumab

    is another immunotherapy drug used in combination with nivolumab in this study. It also helps the immune system target and destroy cancer cells. The trial is investigating whether the combination of ipilimumab and nivolumab is effective in treating patients with advanced thymic carcinoma and type B3 thymoma.

What is already known about the treatment

  • Nivolumab

    Nivolumab is administered as an intravenous infusion, typically given in a hospital or clinical setting. It is currently being studied in clinical trials for its effectiveness in treating type B3 thymoma and thymic carcinoma, particularly in patients who have not responded to chemotherapy. The medication works by blocking a protein called PD-1 on immune cells, which helps the immune system recognize and attack cancer cells. Nivolumab is classified as an immune checkpoint inhibitor, a type of immunotherapy.

  • Ipilimumab

    Ipilimumab is also administered as an intravenous infusion, often in combination with other medications like nivolumab. It is under investigation for its potential to treat type B3 thymoma and thymic carcinoma in patients who have previously undergone chemotherapy. Ipilimumab functions by targeting the CTLA-4 protein on T-cells, enhancing the immune response against cancer cells. It belongs to the pharmacological class of immune checkpoint inhibitors, which are used to boost the body's natural defenses to fight cancer.

Investigated diseases

  • Type B3 Thymoma

    This is a type of tumor that originates in the thymus gland, which is located in the upper chest. It is characterized by the presence of epithelial cells and a few lymphocytes. The tumor can grow slowly and may not cause symptoms initially. As it progresses, it can lead to symptoms such as chest pain, cough, or difficulty breathing due to its location. It may also be associated with autoimmune conditions like myasthenia gravis. The disease can spread to nearby tissues or organs over time.

  • Thymic Carcinoma

    This is a rare and aggressive cancer that also begins in the thymus gland. Unlike thymomas, thymic carcinomas are more likely to spread to other parts of the body. The disease often presents with symptoms such as persistent cough, chest pain, or difficulty swallowing. As it advances, it can invade surrounding tissues and organs, leading to more severe symptoms. Thymic carcinoma is typically more challenging to treat due to its aggressive nature. The progression of the disease can vary, with some cases remaining localized while others spread rapidly.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508658-24-00Protocol code1525-LCGEstimated enrolment99 patientsSponsorEuropean Organisation For Research And Treatment Of Cancer

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).