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Not yet recruitingRare disease

Reducing Toxicity of Dual PD‑1 and CTLA‑4 Checkpoint Therapy in Pleural Mesothelioma Patients with Ustekinumab (anti‑p40)

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on patients with Pleural mesothelioma, a rare cancer that affects the lining of the lungs. The treatment being tested adds an anti‑p40 antibody called ustekinumab to the usual combination of two immune‑boosting medicines known as anti–PD-1 and anti–CTLA-4. These two medicines work together to help the body’s immune system recognize and attack the cancer cells.

The purpose of the study is to see whether giving ustekinumab at the start can lower the number of serious immune‑related side effects, called immune‑related adverse events, that sometimes occur with this dual therapy. Participants will receive the standard two‑medicine regimen together with a dose of ustekinumab, followed by regular check‑ups over several months. During this time doctors will look for any side effects, perform routine blood tests, and use a CT scan of the chest to see how the tumor is responding. The overall follow‑up period lasts up to about six months after treatment begins.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and baseline assessments

    After you agree to join the study, you will sign an informed consent form.

    The study team will collect your medical history, perform physical examinations, and obtain baseline laboratory tests and imaging scans of the chest.

  2. Step 2

    Initial anti‑p40 antibody administration

    You will receive ustekinumab as two separate doses on the first day of treatment.

    The first dose is a subcutaneous injection of 90 mg (provided in a pre‑filled pen).

    The second dose is an intravenous infusion of 520 mg (provided as a concentrate for infusion).

    Both doses are given as a single administration before the start of the dual icb therapy.

  3. Step 3

    Start of dual icb therapy

    Following the anti‑p40 doses, you will begin receiving the dual icb regimen, which includes an anti‑pd‑1 antibody and an anti‑ctla‑4 antibody.

    The specific dosing schedule for these agents is defined by the study protocol and will be administered by the clinical staff.

  4. Step 4

    Regular safety and laboratory monitoring

    Throughout the first 24 weeks, you will attend clinic visits at regular intervals (for example, weekly or every few weeks) to have your vital signs, blood work, and any symptoms evaluated.

    The purpose of these visits is to detect any severe (grade ≥3) immune‑related adverse events, which are side effects caused by the immune‑modulating drugs.

  5. Step 5

    Imaging assessments for tumor response

    Chest ct scans will be performed at baseline, around week 12, and again at week 24 to assess how the tumor is responding to the treatment.

    The scans are interpreted using standardized criteria (mrecist v1.1) to determine objective response.

  6. Step 6

    Extended follow‑up for safety

    After the initial 24‑week period, you will continue to be monitored until week 48.

    Additional clinic visits will focus on identifying any later‑occurring severe (grade ≥3) immune‑related adverse events and on recording disease progression or survival outcomes.

  7. Step 7

    Final study assessments and discontinuation

    At the end of the study period (approximately week 48), a final set of assessments will be performed, including laboratory tests, imaging, and a review of any adverse events.

    You will then discontinue the study medications and receive appropriate follow‑up care as directed by your treating physician.

Who can join the trial?

4 criteria

  • You must have a diagnosis of pleural mesothelioma that cannot be removed by surgery (irresectable), confirmed by laboratory examination of tissue (histology) or cells (cytology).
  • You must be at least 18 years old.
  • Your overall health must be good enough to have an ECOG performance status of 0 or 1 (fully active or able to do light work) or a Karnofsky Performance Scale score of 70 or higher (able to care for yourself but may not do normal activities).
  • You must be eligible to receive dual immune checkpoint blockade (ICB) treatment, which is a combination of two immunotherapy drugs that help the immune system fight the cancer.

Who cannot join the trial?

4 criteria

  • Using medicines that affect the immune system (immunomodulatory drugs) within the 14 days before starting the study treatment.
  • Having a known allergic reaction (hypersensitivity) to the drug ustekinumab, which is being tested in the study.
  • Having an active infection caused by mycobacteria (such as tuberculosis), meaning the infection is currently present and needs treatment.
  • Having long‑lasting or repeatedly returning infections (chronic, recurring infections) that could affect safety during the study.
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Investigated drugs

  • Ustekinumab

    is an anti‑p40 antibody that blocks a protein involved in inflammation. In this trial it is given together with other immunotherapy drugs to see if it can lower the chance of serious immune‑related side effects.

  • Anti‑PD‑1 antibody

    is a type of immune checkpoint inhibitor that helps the body’s immune system recognize and attack cancer cells. In the study patients receive this drug as part of a combination therapy to treat mesothelioma.

  • Anti‑CTLA‑4 antibody

    is another immune checkpoint inhibitor that works by releasing brakes on the immune system, allowing it to fight cancer more effectively. It is used together with the anti‑PD‑1 drug, and the trial tests whether adding ustekinumab can make this combination safer.

What is already known about the treatment

  • Stelara 90 mg solution for injection in pre‑filled pen

    This medication is given as a subcutaneous injection using a pre‑filled pen, allowing the dose to be delivered just under the skin. Ustekinumab, the active ingredient, is an approved treatment for conditions such as plaque psoriasis, psoriatic arthritis, and Crohn’s disease and is well documented in medical literature, though its use in mesothelioma is experimental. It works by attaching to a protein called p40, which is part of the immune signals IL‑12 and IL‑23, thereby lowering the activity of those signals and reducing inflammation. Pharmacologically, it is classified as a human monoclonal antibody that acts as an immune‑system modulator.

  • Stelara 130 mg concentrate for solution for infusion

    This form is administered by slow intravenous infusion, where the medication is diluted in a fluid and delivered directly into a vein over a set period. Ustekinumab in this format is also an approved drug for psoriasis, psoriatic arthritis, and Crohn’s disease, with extensive study data, but its use in this trial for mesothelioma is still investigational. It blocks the same p40 protein of IL‑12 and IL‑23, preventing those signals from triggering excessive immune activity. It belongs to the class of human monoclonal antibodies used as immune‑system regulators.

Investigated diseases

Pleural mesothelioma - Pleural mesothelioma is a cancer that starts in the thin lining (pleura) surrounding the lungs. It begins when abnormal cells grow in this lining and can spread to nearby tissues such as the chest wall or lung tissue. As the disease advances, the pleural lining thickens and fluid may build up in the chest, causing breathing difficulty. The tumor can invade surrounding structures, leading to reduced lung function. Over time, the cancer may extend beyond the chest cavity to other parts of the body.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-526036-38-00Estimated enrolment42 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

sourced from the EU Clinical Trials Register and site verification

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