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

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Universitaet Leipzig Leipzig Germany

Other Sites

Site Name City Country Status
Krankenhaus Nordwest GmbH Frankfurt Germany
Asklepios Kliniken Hamburg GmbH Hamburg Germany
Asklepios Klinik Gauting GmbH Gauting Germany
LungenClinic Grosshansdorf GmbH Grosshansdorf Germany
Gesellschaft Zur Forderung Des Wissenschaftlich Medizinischen Erkenntnisgewinns In Der Hamatologie Und Oncologie Munster Germany
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH Regensburg Germany
Sana Klinikum Offenbach GmbH Offenbach Am Main Germany
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Kliniken der Stadt Koeln gGmbH Cologne Germany
Cliniche Gavazzeni S.p.A. Bergamo Italy
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Awwmidh Ooibajjzcyb Nvyevzexg Sm Ablrnqr E Bskzcg E C Aklazk Arwweaivhun Alexandria Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
30.04.2026
Italy Italy
Recruiting
30.04.2026

Trial locations

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.

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 ID:
2025-523947-36-00
Protocol code:
D798MC00002
NCT ID:
NCT06535607
Trial Phase:
Therapeutic exploratory (Phase II)

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