AuthorisedTherapeutic exploratory (Phase II)Interventional

Giving Upfront Anti-p40 to Reduce toxicity from Dual Immune Checkpoint Inhibition in MESOthelioma

Pleural mesothelioma is a cancer affecting the lining of the lungs. A common and promising treatment involves using two immunotherapy medicines together. These medicines encourage your immune system to find and fight cancer cells. However, this powerful immune response can sometimes cause severe inflammation in healthy parts of the body, leading to harsh side effects. This Phase II trial is exploring whether giving an anti-inflammatory drug called Stelara alongside standard immunotherapy can prevent these serious complications. Stelara is already used for other immune-related conditions and works by calming specific inflammatory signals. Participants receive Stelara either by a drip into a vein or through an injection under the skin. Doctors will monitor participants closely over 24 to 48 weeks with regular check-ups, chest CT scans, and blood tests to ensure the cancer treatment remains effective while keeping side effects as low as possible.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Enrolment target

Start

09 Jul 2026

Pleural mesothelioma

What is this study about?

Pleural mesothelioma is a type of cancer that develops in the thin layer of tissue covering the lungs, known as the pleura. It is often linked to past exposure to asbestos. In recent years, immunotherapy has become an important treatment for this condition. Immunotherapy works by boosting the body's natural defences to help them recognise and destroy cancer cells. Often, doctors combine two different immunotherapy drugs to achieve the strongest possible effect against the tumour.

While combining these two drugs can be very effective, it can also cause the immune system to become overactive. When this happens, immune cells may attack healthy tissues, causing complications known as immune-related adverse events. These can cause serious inflammation in organs such as the bowels, lungs, skin, or liver, sometimes forcing patients to pause or stop their cancer treatment completely.

This study looks at a new approach to prevent these problems before they start. Researchers are giving patients a medicine called Stelara (ustekinumab) right from the beginning of their immunotherapy. Stelara targets a specific protein involved in inflammation called p40. Doctors hope that by blocking this protein, they can shield healthy organs from harsh side effects while still allowing the immunotherapy to fight the mesothelioma.

If the study is successful, it could help patients stay on their cancer treatments for longer with fewer hospital visits and a better quality of life. The findings could also guide how doctors manage side effects for other cancers treated with combination immunotherapy.

Key takeaways

Tests whether adding Stelara can protect patients from severe side effects caused by double-immunotherapy.
Aimed at adults aged 18 and over diagnosed with pleural mesothelioma.
Stelara is given by a drip or a simple injection under the skin.
Participants receive close monitoring, regular blood tests, and chest CT scans for at least 24 to 48 weeks.
Taking part is completely voluntary, and you can withdraw at any time.

Who may be eligible?

This trial is open to adults aged 18 and older who have been diagnosed with pleural mesothelioma and are scheduled to start treatment with dual immunotherapy. Both men and women are welcome to join.

Because the study involves modifying the immune system, people with certain pre-existing conditions may not be able to take part. For instance, having an active, serious infection or severe uncontrolled health conditions might mean the trial is not safe for you.

Your cancer specialist will review your full medical history, blood tests, and scans to confirm whether you meet all the safety rules needed to join the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am 18 years old or older.
I have been diagnosed with pleural mesothelioma.
My doctor has recommended treatment with two immunotherapy medicines.
I do not have any active, severe infections.
I am able and willing to attend regular hospital appointments for check-ups and scans.

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will receive Stelara alongside your regular dual immunotherapy. Stelara may be given as an infusion (a slow drip into a vein in your arm) or as an injection under the skin using a pre-filled pen device. Your clinical team will explain your exact dosing schedule.

You will have regular hospital visits, especially during the first 24 weeks of treatment. During these appointments, your care team will check your overall health, monitor any symptoms or side effects, and take routine blood samples. You will also have scheduled chest CT scans to check how your tumour is responding to the treatment.

Your participation will be monitored closely for at least 24 to 48 weeks. Even after treatment finishes, the research team may continue to check on your health through follow-up visits or phone calls to see how you are doing over the longer term.

Potential risks and benefits

The main potential benefit is that Stelara may protect you from severe and uncomfortable side effects caused by dual immunotherapy, allowing you to continue your cancer treatment more comfortably. You will also receive very close, dedicated monitoring from a specialist cancer team. However, there is no guarantee that Stelara will prevent side effects, and it can cause its own mild side effects, such as a sore throat, headache, or redness where the injection is given. It may also slightly increase your risk of common infections. Taking part is completely voluntary. You are free to leave the trial at any time without giving a reason, and your standard NHS medical care will not be affected in any way.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is Stelara?

Stelara is an approved medicine that calms down specific parts of the immune system. It is commonly used to treat inflammatory conditions like severe psoriasis and bowel inflammation.

Could Stelara stop my cancer treatment from working?

Researchers believe Stelara calms specific inflammatory pathways without stopping the immune system's ability to attack cancer cells. The trial team will carefully track your tumour with regular CT scans to ensure the cancer treatment remains effective.

How is the trial medicine given?

Stelara is given either through a slow drip into a vein (an intravenous infusion) or as a small injection under the skin, often around the tummy or thigh.

Will taking part cost me anything?

No. The trial medication, hospital tests, and extra monitoring are provided free of charge as part of the clinical study.

Can I leave the study if I change my mind?

Yes. You can leave the study at any point. Deciding to withdraw will never affect your relationship with your healthcare team or your access to standard NHS cancer care.