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Volrustomig in Patients with Unresectable Pleural Mesothelioma and Esophageal Squamous Cell Carcinoma

Fast replyRegistered drugNo placebo
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What is this trial about?

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

This clinical trial is studying two advanced cancers: esophageal squamous cell carcinoma, a cancer that starts in the lining of the food pipe, and unresectable pleural mesothelioma, a cancer of the thin lining around the lungs that cannot be removed with surgery. The purpose of the study is to see how well volrustomig works and how safe it is. Volrustomig will be given by vein alone in one part of the study, and in another part it will be given with cancer drugs. These cancer drugs include paclitaxel, fluorouracil, and cisplatin, which are medicines used to kill cancer cells. Other medicines may also be used to help lower immune system side effects, including mycophenolate mofetil and infliximab.

In the study, treatment is given over time and people are followed for several years. Some participants receive volrustomig by itself, while others receive it together with chemotherapy. During the study, health problems and side effects are watched closely, and treatment may be adjusted or stopped if needed. The study is designed to compare how the different treatment approaches work in these advanced cancers.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>trial treatment begins</b>

    After joining the study, you start one of the study treatment plans for your type of cancer.

    The study includes two possible stages: volrustomig alone for unresectable pleural mesothelioma, or volrustomig together with chemotherapy for esophageal squamous cell carcinoma.

  2. Step 2

    <b>volrustomig alone</b>

    If you are in the volrustomig monotherapy stage, you receive volrustomig as an intravenous infusion, which means it is given into a vein.

    The provided source does not state the dose, how often it is given, or how long it is given.

  3. Step 3

    <b>volrustomig with chemotherapy</b>

    If you are in the combination stage, you receive volrustomig as an intravenous infusion together with chemotherapy medicines.

    The chemotherapy medicines listed are paclitaxel given by intravenous use, fluorouracil given by intravenous use, and cisplatin given by intravenous use.

    The source does not state the dose, how often each medicine is given, or how long each medicine is given.

  4. Step 4

    <b>background medicines</b>

    Some study participants also receive background medicines listed in the source.

    mycophenolate mofetil is given by mouth, and infliximab is given by intravenous use.

    The source does not state the dose, how often these medicines are given, or how long they are given.

  5. Step 5

    <b>study checks during treatment</b>

    During the study, your condition is checked to see whether the cancer has a response, stays controlled, or gets worse.

    The study also checks for side effects, including serious side effects, changes in ecg (an electrocardiogram, which is a test that records the heart's electrical activity), laboratory results, and vital signs.

    These checks continue through study completion, which is planned for an average of about 4 years.

  6. Step 6

    <b>end of study follow-up</b>

    The study continues until completion, with planned follow-up over an average of about 4 years.

    The study measures how long any cancer response lasts, how long it takes for a response to first appear, how long the cancer stays under control, overall survival, and blood levels and immune response to volrustomig.

Who can join the trial?

8 criteria

  • Be 18 years of age or older when signing the informed consent form, which is the written permission to take part in the study.
  • Provide a tumor sample so the study team can check PD-L1 expression, which means looking for a protein on the cancer cells that may help guide treatment.
  • Have an ECOG performance status of 0 or 1. This is a measure of daily activity level; 0 means fully active, and 1 means able to do light work but not heavy physical work.
  • Have measurable disease according to RECIST 1.1, meaning the cancer must be present in a way that can be measured on scans or exams using standard study rules.
  • Have a life expectancy of at least 12 weeks, meaning the doctor expects the person to live for 3 months or longer.
  • Have adequate organ and bone marrow function, meaning the major organs and the bone marrow, which makes blood cells, must be working well enough for study treatment.
  • Weigh more than 35 kg.
  • Be able and willing to sign informed consent, meaning the person can understand the study and agree to join in writing.

Who cannot join the trial?

18 criteria

  • Spinal cord compression, which means pressure on the spinal cord that can cause pain, weakness, or numbness.
  • Any previous treatment with immune-based therapy (treatment that works by changing how the immune system responds to cancer).
  • Use of immunosuppressive medicine within 14 days before the first study dose, except for allowed short-term or local steroid use such as nasal, inhaled, skin, joint, scan, or chemotherapy premedication steroids, or a single dose for symptom relief.
  • For sub-study 4, any anti-cancer treatment within 28 days before the first study dose, or within 5 medicine half-lives, whichever is longer. A half-life is the time it takes for half of a drug to leave the body.
  • Any other cancer treatment at the same time, such as chemotherapy, radiotherapy, investigational treatment, biologic therapy (treatment made from living cells or proteins), or hormonal therapy, unless it is the study treatment.
  • Radiotherapy (treatment with radiation) to a wide area or to more than 30% of the bone marrow within 4 weeks before the first study dose. The bone marrow is the soft tissue inside bones that makes blood cells.
  • Major surgery within 4 weeks before the first study dose, or still not fully recovered from surgery.
  • Receipt of a live attenuated vaccine within 30 days before the first study dose. This is a vaccine with a weakened live germ.
  • Known allergy or sensitivity to any study drug or any ingredient in the study drug.
  • For sub-study 4, brain metastases unless they are without symptoms, stable, and do not need steroids for at least 14 days before starting treatment. Brain metastases means cancer that has spread to the brain.
  • For sub-study 5, untreated or getting worse brain metastases.
  • Not recovered from side effects caused by a previous anti-cancer treatment, meaning the side effects are still worse than mild or have not returned to the person’s usual level.
  • For sub-study 4, any medical reason that makes the person unable to take 5-FU, paclitaxel, or carboplatin, which are cancer medicines used in this study.
  • A history of another cancer, except if the cancer was treated with the goal of cure, has shown no active disease for at least 2 years, and is considered low risk for coming back. Also allowed are properly treated non-melanoma skin cancer, lentigo maligna, or carcinoma in situ without signs of disease. Carcinoma in situ means very early cancer that has not spread into deeper tissue.
  • Any disease, or a history of organ transplant or allogeneic stem cell transplant (a transplant using cells from another person), that could make study participation unsafe or make it hard to follow the study rules.
  • Active infection, including tuberculosis; HIV that is not well controlled; active or uncontrolled hepatitis B or hepatitis C; or active hepatitis A.
  • History of primary immunodeficiency (a condition where the immune system does not work properly) or a documented autoimmune or inflammatory disorder, either currently or in the past. Autoimmune means the immune system attacks the body’s own tissues.
  • Being a candidate for curative therapy, meaning there is a treatment option intended to cure the disease.
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Investigated drugs

  • Volrustomig

    is the main study drug in this trial. It is given through a vein as an infusion. The trial is looking at how well it works by itself or when combined with other cancer medicines in people with advanced or spread-out solid tumors.

  • Paclitaxel

    is a cancer medicine given through a vein. In this trial, it is used as one of the treatment options combined with the study drug to help treat the cancer cells.

  • Fluorouracil

    is a cancer medicine given through a vein. It is used in the trial as part of a treatment combination to slow down or stop cancer growth.

  • Cisplatin

    is a cancer medicine given through a vein. In this trial, it is used together with other treatment to attack cancer cells and help control the disease.

  • Mycophenolate mofetil

    is taken by mouth and is used to calm down the immune system. In this trial, it is part of the background treatment, meaning it may be given to support the main study treatment and help manage immune-related effects.

  • Infliximab

    is given through a vein and helps reduce inflammation by lowering immune system activity. In this trial, it is used as background treatment, usually to help control immune-related side effects from treatment.

What is already known about the treatment

  • Paclitaxel

    Paclitaxel is given by intravenous infusion, which means it is delivered directly into a vein in a hospital or clinic. It is a well-known cancer medicine that is widely used in medical practice and studied for many years. It is used to treat several cancers, including breast, lung, ovarian, and esophageal cancer, and it works by stopping cancer cells from dividing. At the molecular level, it binds to tiny cell structures called microtubules and keeps them stable, which prevents the cell from completing division; it is classified as an anti-cancer taxane chemotherapy drug.

  • Mycophenolate mofetil

    Mycophenolate mofetil is taken by mouth as capsules or tablets, and it is usually swallowed with water as directed by a doctor. It is an established medicine in current medical use and is well described in the medical literature, mainly as a drug that lowers immune activity. It is commonly used to prevent organ rejection after transplantation and is also used in some autoimmune conditions. At the molecular level, it blocks an enzyme that immune cells need to make DNA, which slows the growth of these cells; it is classified as an immunosuppressant.

  • Volrustomig

    Volrustomig is given by intravenous infusion, meaning it is administered slowly through a vein under medical supervision. It is a newer investigational medicine and is still being studied in clinical trials, so its full role in routine medical care is not yet established. It is being explored for advanced cancers such as esophageal squamous cell carcinoma and unresectable pleural mesothelioma. At the molecular level, it is designed as an antibody-based cancer treatment that helps the immune system recognize and attack tumor cells; it is classified as an anti-cancer immunotherapy agent.

  • Infliximab

    Infliximab is given by intravenous infusion in a clinic or hospital setting. It is a well-established medicine with extensive use in medical practice and literature. It is mainly used for autoimmune diseases such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, psoriasis, and related conditions. At the molecular level, it attaches to a protein called tumor necrosis factor alpha (TNF-alpha) and blocks its action, which reduces inflammation; it is classified as a monoclonal antibody and an anti-inflammatory immunosuppressive medicine.

  • Fluorouracil

    Fluorouracil is given by intravenous infusion, and in some settings it can also be used in other forms depending on the condition being treated. It is a classic and well-studied cancer medicine that has been used for many years in oncology. It is commonly used for cancers of the colon, rectum, stomach, breast, and head and neck, and it helps stop cancer cells from growing. At the molecular level, it interferes with DNA building and repair, which damages fast-growing cells; it is classified as an anti-cancer antimetabolite chemotherapy drug.

  • Cisplatin

    Cisplatin is given by intravenous infusion, usually in a hospital or cancer treatment center. It is a long-established medicine with a strong place in medical practice and medical literature. It is used to treat several cancers, including testicular, ovarian, bladder, lung, and head and neck cancers, and it is often part of combination treatment plans. At the molecular level, it forms harmful links in DNA that block cancer cells from copying themselves and surviving; it is classified as a platinum-based anti-cancer chemotherapy drug.

Investigated diseases

  • Unresectable Pleural Mesothelioma

    A cancer that starts in the thin lining around the lungs and chest wall, and cannot be removed completely by surgery. It usually grows as thickening or nodules in the pleura and may slowly spread across the chest lining and into nearby tissues. As it progresses, it can cause increasing chest pain, shortness of breath, and fluid buildup around the lungs. The disease often becomes more widespread within the chest over time.

  • Esophageal Squamous Cell Carcinoma

    A cancer that begins in the flat cells lining the esophagus, the tube that carries food from the mouth to the stomach. It usually starts as a small growth or thickened area and can gradually widen or deepen into the esophageal wall. As it progresses, it may narrow the esophagus and spread to nearby tissues or lymph nodes. The disease commonly becomes more advanced over time if it continues to grow.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523947-36-00Protocol codeD798MC00002Estimated enrolment245 patientsSponsorAstraZeneca AB

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