Study of Nivolumab, Ipilimumab, and UV1 Vaccine for Patients with Malignant Pleural Mesothelioma After Initial Chemotherapy

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What is this study about?

This clinical trial is focused on studying a type of cancer called malignant pleural mesothelioma, which affects the lining of the lungs. The study is investigating the effectiveness of a combination of treatments for patients whose cancer has progressed after initial chemotherapy. The treatments being tested include two medications, nivolumab and ipilimumab, which are given through an intravenous infusion, meaning they are delivered directly into the bloodstream. Additionally, some patients will receive a vaccine called UV1, which is administered as an injection under the skin. The purpose of the study is to evaluate and compare how well these treatments work in controlling the cancer.

Participants in the study will receive either the combination of nivolumab and ipilimumab with the UV1 vaccine or without it. The study will last for a period of up to 24 months, during which patients will receive regular treatments and be monitored closely by healthcare professionals. The study aims to determine if adding the UV1 vaccine to the treatment regimen improves outcomes for patients with this type of cancer.

Throughout the study, researchers will assess various aspects of the treatment’s effectiveness, such as how long patients live without the cancer getting worse and the overall survival rate. They will also monitor the patients’ quality of life and any side effects experienced during the treatment. This information will help determine the potential benefits and risks of using these treatments for malignant pleural mesothelioma.

1 initial assessment

Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes reviewing medical history and conducting necessary tests such as imaging scans to measure the disease.

2 treatment initiation

The treatment phase begins with the administration of medications. You will receive nivolumab and ipilimumab through an intravenous infusion. This means the medication is given directly into a vein.

The dosage and frequency of these medications will be determined by the study protocol and your healthcare provider.

3 optional UV1 vaccination

Some participants may receive an additional UV1 vaccination. This is administered intradermally, which means it is injected into the skin.

The decision to include this vaccination will be based on the study design and your specific treatment plan.

4 regular monitoring

Throughout the trial, regular monitoring will be conducted to assess your response to the treatment. This includes routine blood tests, imaging scans, and physical examinations.

You will be asked to report any side effects or changes in your health to the study team.

5 quality of life assessments

You will be asked to complete questionnaires about your quality of life. These assessments help understand the impact of the treatment on your daily activities and overall well-being.

6 end of treatment evaluation

At the end of the treatment period, a comprehensive evaluation will be conducted. This includes final imaging scans and laboratory tests to determine the overall effectiveness of the treatment.

Your healthcare provider will discuss the results with you and outline any further steps or follow-up care needed.

Who Can Join the Study?

Diagnosis of malignant pleural mesothelioma, confirmed by a doctor through tests.
The disease cannot be removed by surgery.
At least one tumor that can be measured using a CT or MRI scan.
Provide a sample of the tumor tissue for analysis. This means having enough tissue from a previous biopsy (a procedure to take a small piece of tissue for testing).
Must be 18 years of age or older.
Have a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
Agree to provide tumor tissue and blood samples for research purposes.
Have adequate organ function, which includes:
- Hemoglobin level of at least 9.0 g/dL (a measure of red blood cells).
- Absolute neutrophil count (ANC) of at least 1,500 per mm³ (a type of white blood cell).
- Platelet count of at least 75,000 per mm³ (cells that help with blood clotting).
- Serum bilirubin level no more than 1.5 times the normal limit (a substance made by the liver).
- AST (SGOT) and ALT (SGPT) levels no more than 2.5 times the normal limit, unless there are liver metastases, in which case no more than 5 times the normal limit (enzymes that indicate liver function).
- Creatinine clearance greater than 40 mL/min, which is a measure of kidney function.
Previously treated with at least one line of platinum-based chemotherapy.

Who Cannot Join the Study?

Patients who have not been diagnosed with malignant pleural mesothelioma cannot participate. This is a type of cancer that affects the lining of the lungs.
Patients who have not received first-line platinum-based chemotherapy cannot participate. This is a common initial treatment for certain types of cancer.
Patients who have had surgery to remove the cancer cannot participate. The study is for those with inoperable cancer, meaning it cannot be removed by surgery.
Patients who are not experiencing cancer progression after the initial treatment cannot participate. This means the cancer must be getting worse after the first treatment.
Patients who are part of a vulnerable population cannot participate. This typically includes groups like children, pregnant women, or those unable to give consent.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Karolinska University Hospital	Solna	Sweden
Oslo University Hospital HF	Oslo	Norway
Copenhagen University Hospital	Copenhagen	Denmark
Aalborg University Hospital	Aalborg	Denmark
Vall D Hebron Institute Of Oncology	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	15.05.2020
Norway	Not recruiting	15.05.2020
Spain	Not recruiting	15.05.2020
Sweden	Not recruiting	15.05.2020

Trial locations

Investigated drugs:

Nivolumab is a type of medication known as an immune checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells. In this trial, it is being used to treat patients with a type of cancer called malignant mesothelioma, which affects the lining of the lungs. Nivolumab is given to patients whose cancer has not responded to initial treatments.

Ipilimumab is another immune checkpoint inhibitor. It helps boost the immune system’s response against cancer cells. Like nivolumab, it is used in this trial for patients with malignant mesothelioma who have not had success with their first treatment. The combination of ipilimumab and nivolumab aims to enhance the body’s ability to fight the cancer.

UV1 Vaccine is an experimental cancer vaccine. It is designed to stimulate the immune system to target and destroy cancer cells. In this trial, the UV1 vaccine is being tested to see if it can improve the effectiveness of nivolumab and ipilimumab in treating malignant mesothelioma. The goal is to see if adding the vaccine can help control the cancer better than using the medications alone.

Investigated diseases:

Pleural mesothelioma malignant

Malignant pleural mesothelioma – Malignant pleural mesothelioma is a rare cancer that develops in the thin layer of tissue surrounding the lungs, known as the pleura. It is primarily caused by exposure to asbestos fibers, which can lead to cellular changes over time. The disease typically begins with the formation of small nodules on the pleura, which can grow and merge into larger tumors. As the tumors expand, they can cause the pleura to thicken and fluid to accumulate in the pleural space, leading to symptoms such as chest pain and difficulty breathing. The progression of the disease can involve the invasion of nearby tissues and organs, including the lungs and chest wall. Over time, malignant pleural mesothelioma can spread to distant parts of the body through the bloodstream or lymphatic system.

Trial ID:

2022-502604-67-00

Trial Phase:

Therapeutic use (Phase IV)

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Study of Nivolumab, Ipilimumab, and UV1 Vaccine for Patients with Malignant Pleural Mesothelioma After Initial Chemotherapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?