Study on Pembrolizumab and Lenvatinib for Patients with Pre-Treated Thymic Carcinoma and B3-Thymoma

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What is this study about?

This clinical trial is focused on studying the effectiveness and safety of a combination treatment for patients with a type of cancer called thymic carcinoma and a subtype known as B3-thymoma. These are rare cancers that occur in the thymus, a small organ in the upper chest. The treatment being tested includes two medications: pembrolizumab, also known by its code name MK-3475, and lenvatinib, known by its code name MK-7902. Pembrolizumab is given as an infusion, which means it is administered directly into the bloodstream through a vein, while lenvatinib is taken orally in capsule form.

The purpose of this study is to evaluate how well this combination of medications works in patients who have already received other treatments for their cancer. The study will look at how long patients can live without their disease getting worse over a period of five months. Participants will receive the treatment for up to 24 months, and their health will be monitored regularly to assess the treatment’s effects and any side effects they may experience.

Throughout the study, researchers will also gather information on how the cancer responds to the treatment, including any reduction in tumor size and overall survival rates. The safety of the treatment will be closely monitored to ensure it is well-tolerated by patients. This study aims to provide valuable insights into the potential benefits of using pembrolizumab and lenvatinib together for treating thymic carcinoma and B3-thymoma.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, you will receive detailed information about the trial, and any questions you have will be answered. You will be asked to provide written informed consent to confirm your willingness to participate.

A series of tests will be conducted to ensure you meet the eligibility criteria. These tests may include blood tests, imaging scans like CT or MRI, and a review of your medical history.

2 treatment initiation

Once eligibility is confirmed, you will begin the treatment phase. This involves receiving two medications: pembrolizumab and lenvatinib.

Pembrolizumab will be administered as an intravenous infusion. This means the medication will be given through a vein in your arm. The infusion will occur once every three weeks.

Lenvatinib will be taken orally in the form of capsules. You will take these capsules daily. The exact dosage will be determined by your healthcare provider based on your specific needs.

3 ongoing monitoring

Throughout the trial, regular visits will be scheduled to monitor your health and the effects of the treatment. These visits will include physical exams, blood tests, and imaging scans to assess the progress of the treatment.

You will be asked to report any side effects or changes in your health to the study team. This information is crucial for ensuring your safety and the success of the trial.

4 end of treatment

The treatment phase will continue until the study’s end date or until it is determined that the treatment is no longer beneficial for you.

At the end of the treatment phase, a final assessment will be conducted. This will include a comprehensive evaluation of your health and the overall outcomes of the treatment.

5 follow-up

After completing the treatment, follow-up visits will be scheduled to monitor your long-term health and any lasting effects of the treatment.

These visits are important for gathering information on the long-term efficacy and safety of the treatment combination.

Who Can Join the Study?

You have been diagnosed with relapsed or recurrent B3-Thymoma or Thymic Carcinoma (TC) that cannot be treated with surgery or radiotherapy to cure it.
You are at least 18 years old.
You are not pregnant or breastfeeding if you are a woman. If you can have children, you agree to use birth control during the study and for at least 6 months after the last dose of the study treatment.
You have adequate bone marrow and organ function.
You have signed a written informed consent form before starting any study procedures.
You have previously been treated with at least one line of platinum-based chemotherapy for advanced disease. If you had chemotherapy combined with surgery or chemoradiotherapy, it must have been completed within 6 months before joining the study.
You have tested negative for Myasthenia Gravis (MG) by an acetylcholine receptor antibodies test within 6 months before the screening visit.
You have an ECOG performance status of 0-1, which means you are fully active or have some symptoms but can carry out light work.
You have a life expectancy of at least 3 months.
Your disease has shown progression according to RECIST 1.1 criteria during or after previous therapy, as determined by the investigator.
You have measurable disease according to RECIST 1.1 criteria. If you have lesions in an area that was previously treated with radiation, they are considered measurable if they have shown progression. Your disease status must be documented by a full chest and upper abdomen CT or MRI within 28 days before joining the study. If needed, brain imaging must be done.
You can provide a historical or fresh tumor biopsy sample for biomarker studies, if possible. A sample from a tumor that has not been previously irradiated is acceptable. Newly obtained biopsies are preferred.

Who Cannot Join the Study?

Patients with other types of cancer that are not B3-thymoma or Thymic carcinoma cannot participate.
Patients who have not been treated before for their B3-thymoma or Thymic carcinoma are excluded.
Patients who have not experienced a return or worsening of their B3-thymoma or Thymic carcinoma after treatment cannot join.
Patients who are not within the specified age range for the study are excluded.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.

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
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Virgen del Rocío University Hospital	Sevilla	Spain
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Axtjvaawcz Pkszxtaj Hktfbxri Du Mhfuivwat	Marseille	France
Hgjzvqml Dp Lh Slmsx Cqyr I Sseb Pcs	Barcelona	Spain
Fxvmvytmp Piqk Le Inicvsofntpxl Bbkalyouv Dwm Heexfmfh Uxijcvytgscsi Lg Prs	Madrid	Spain
Ctygnu Ovvoo Lwgkoio	Lille	France
Hflxdhbi Uheptjhccefig dq A Clxssp	A Coruna Galicia	Spain
Ikgxeejh Cnahw	Paris	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	13.05.2022
Italy	Not recruiting	13.05.2022
Spain	Not recruiting	13.05.2022

Trial locations

Investigated drugs:

Pembrolizumab is a type of medication known as an immunotherapy. It works by helping your immune system fight cancer cells. Pembrolizumab targets a specific protein on the surface of cells, which can help your immune system recognize and attack cancer cells more effectively. This medication is used in this trial to see if it can help control thymic carcinoma, a type of cancer that affects the thymus gland, in patients who have already received other treatments.

Lenvatinib is a medication that belongs to a group of drugs called tyrosine kinase inhibitors. It works by blocking certain proteins that cancer cells need to grow and spread. By interfering with these proteins, lenvatinib can help slow down or stop the growth of cancer cells. In this trial, lenvatinib is being used in combination with pembrolizumab to see if it can improve the treatment outcomes for patients with thymic carcinoma who have not responded well to previous treatments.

Investigated diseases:

Thymic Carcinoma – Thymic carcinoma is a rare type of cancer that originates in the thymus gland, which is located in the upper chest. Unlike thymomas, thymic carcinomas are more aggressive and can spread to other parts of the body. The disease often begins with the formation of a tumor in the thymus, which can grow and invade nearby tissues. As the cancer progresses, it may metastasize to distant organs, including the lungs and liver. Symptoms can include chest pain, cough, and difficulty breathing due to the tumor pressing on nearby structures. The progression of thymic carcinoma can vary, with some tumors growing slowly and others advancing more rapidly.

B3-Thymoma – B3-thymoma is a subtype of thymoma, a tumor originating from the epithelial cells of the thymus gland. This type of thymoma is characterized by a mixture of lymphocytes and epithelial cells, with the epithelial component being more prominent. B3-thymomas are generally considered to be more aggressive than other types of thymomas, with a higher potential for local invasion and recurrence. The disease typically begins with the formation of a mass in the thymus, which can cause symptoms such as chest pain, cough, and shortness of breath. As the tumor grows, it may invade surrounding tissues and, in some cases, spread to other parts of the body. The progression of B3-thymoma can vary, with some cases remaining localized while others may become more advanced.

Trial ID:

2023-508001-25-00

Protocol code:

MedOPP341

NCT ID:

NCT04710628

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Pembrolizumab and Lenvatinib for Patients with Pre-Treated Thymic Carcinoma and B3-Thymoma

What is this study about?

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Who Cannot Join the Study?