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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
University Hospital Maastricht	Maastricht	The Netherlands
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Institut Jules Bordet	Anderlecht	Belgium
Netherlands Cancer Institute	Amsterdam	The Netherlands
Hospital Universitario 12 De Octubre	Madrid	Spain
Centre Hospitalier Lyon Sud	Pierre Benite	France
Centre Francois Baclesse	Caen	France
Ahcrepighe Pybhsabz Hypnilay Dg Mltrmcqna	Marseille	France
Eemkwyt Ujefrieddhzw Mqfqgbb Cysjpwh Rxazdnhdc (sqazrvv Mpl	Rotterdam	The Netherlands
Uozbxhpjpn Ot Atearby	Edegem	Belgium
Hrwjpkat Vvnz dptmtaij	Barcelona	Spain
Ieqlkued Cdegj	Paris	France

Trial status

Country	Status	Recruitment Start
Belgium	Not yet recruiting	28.02.2018
France	Not yet recruiting	28.02.2018
Spain	Not yet recruiting	28.02.2018
The Netherlands	Not yet recruiting	28.02.2018

Trial locations

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.

Investigated diseases:

Thymoma malignant

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 ID:

2023-508658-24-00

Protocol code:

1525-LCG

NCT ID:

NCT03134118

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?