In short
There is currently 1 ongoing clinical trial for patients with malignant thymoma, specifically focusing on type B3 thymoma and thymic carcinoma. This trial is testing immunotherapy treatments using nivolumab and ipilimumab in patients whose cancer has returned or progressed after chemotherapy. The study is being conducted across multiple European countries including Belgium, France, the Netherlands, and Spain.
Clinical trial locations
- Belgium
- France
- Netherlands
- Spain
Study of Nivolumab and Ipilimumab for Patients with Type B3 Thymoma and Thymic Carcinoma After Chemotherapy
This clinical trial focuses on patients with type B3 thymoma and thymic carcinoma, which are cancers that develop in the thymus gland located in the upper chest. The study is testing immunotherapy treatments to help the body's immune system fight these cancers.
Who can participate:
The trial is looking for patients who meet specific criteria:
- Adults aged 18 years or older with type B3 thymoma or thymic carcinoma that has returned or spread and cannot be cured with surgery
- Previous treatment with at least one platinum-based chemotherapy regimen is required
- The cancer must be measurable using medical imaging tests and must have shown progression
- Good kidney function with creatinine clearance of 50 mL/min or higher
- Adequate blood counts including sufficient white blood cells, hemoglobin, and platelets
- Proper liver function as measured by specific blood tests
- Performance status of 0 to 2 on the WHO scale, meaning the patient can perform most daily activities
- Tumor tissue samples must be available for testing, including checking for PD-L1 markers
- Women of childbearing age must have a negative pregnancy test and agree to use effective birth control during the study and for 5 months after treatment ends. Men must use birth control during the study and for 7 months after treatment
- Women who are breastfeeding must stop before starting treatment and should not resume for at least 5 months after the last treatment dose
Who cannot participate:
The trial excludes patients who do not meet the age requirements, belong to vulnerable populations requiring special protection, or have not previously received platinum-based chemotherapy treatment.
What the trial is testing:
The study evaluates two immunotherapy medications: nivolumab and ipilimumab. Both medications are given through an intravenous infusion directly into the bloodstream. Nivolumab works by blocking a protein called PD-1 on immune cells, helping the immune system recognize and attack cancer cells. Ipilimumab targets another protein called CTLA-4 on immune cells, further boosting the immune response against cancer.
Participants will receive either nivolumab alone or a combination of nivolumab and ipilimumab. The study follows patients over time through regular check-ups and medical imaging to monitor how well the cancer responds to treatment and to assess safety.
Main goals of the trial:
The primary goal is to measure the Progression Free Survival Rate at 6 months, meaning how many patients remain alive without their cancer getting worse during this period. Secondary goals include evaluating the overall response rate, disease control rate, and overall survival. The study also monitors for any side effects using standard safety assessment guidelines.
The trial follows a structured approach starting with initial assessment to confirm eligibility, followed by treatment initiation with the immunotherapy medications. Regular monitoring includes imaging studies and safety assessments. Based on the results, patients may continue treatment or conclude their participation in the study. In some cases, treatment may continue even after disease progression if the study investigators believe it could still be beneficial.
Summary
Currently, there is one active clinical trial available for patients with malignant thymoma, specifically focusing on type B3 thymoma and thymic carcinoma. This trial represents an important research effort in exploring immunotherapy options for patients whose cancer has progressed after standard chemotherapy treatment.
The trial is being conducted across four European countries: Belgium, France, the Netherlands, and Spain, providing access to this research for patients in multiple locations. The study focuses on two specific immunotherapy drugs, nivolumab and ipilimumab, which belong to a class of medications called immune checkpoint inhibitors. These medications work by helping the patient's own immune system recognize and fight cancer cells.
For patients with type B3 thymoma or thymic carcinoma who have completed platinum-based chemotherapy and whose disease has progressed, this trial may offer an opportunity to access potential new treatment options while contributing to research that could help future patients with these rare cancers.
