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Study on Avelumab for Patients with Advanced Urothelial Cancer After Initial Chemotherapy

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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 focused on studying the effects of a treatment for urothelial cancer, which includes bladder cancer and muscle invasive bladder cancer. The treatment being tested is a medication called Bavencio, which contains the active substance avelumab. Avelumab is a type of protein that helps the immune system fight cancer cells. The medication is given as a solution through an intravenous infusion, meaning it is administered directly into the bloodstream through a vein.

The purpose of this study is to see if using avelumab for a short period, up to six months, can help patients with advanced urothelial cancer live longer. These patients have already received chemotherapy that includes platinum-based drugs, and their cancer has not worsened during or after this initial treatment. The study will observe patients over a period of 18 months to determine if the treatment improves their overall survival.

Participants in the study will receive either the avelumab treatment or a placebo. The study will monitor the patients' health and response to the treatment over time, focusing on how long they live and how their cancer responds to the treatment. The trial aims to provide valuable information on whether avelumab can be an effective maintenance therapy for patients with this type of cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    The trial begins with an initial assessment to confirm eligibility. This includes a review of medical history and current health status.

    Eligibility criteria include a confirmed diagnosis of advanced urothelial cancer, completion of prior chemotherapy, and a minimum age of 18 years.

  2. Step 2

    Treatment initiation

    The treatment phase involves receiving avelumab, administered as an intravenous infusion.

    The medication is provided in the form of Bavencio 20 mg/mL concentrate for solution for infusion.

  3. Step 3

    Treatment schedule

    The treatment is scheduled to last for a maximum of six months.

    Infusions are administered regularly, with the frequency determined by the study protocol.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess the response to treatment and overall health.

    This includes laboratory tests and imaging studies to evaluate the status of the cancer.

  5. Step 5

    Completion of treatment

    Upon completion of the six-month treatment period, a final assessment is conducted.

    The primary goal is to evaluate overall survival at 18 months post-treatment.

Who can join the trial?

15 criteria

  • The patient must have a confirmed diagnosis of **urothelial cancer**, which is a type of cancer that affects the bladder and urinary system.
  • The cancer must be **unresectable**, meaning it cannot be removed with surgery, and it should be **locally advanced** or **metastatic**, indicating it has spread to other parts of the body.
  • The patient should have **Stage IV disease**, which is an advanced stage of cancer.
  • The patient must have completed **4 to 6 cycles** of a specific type of chemotherapy, which includes drugs like **gemcitabine** and **cisplatin** or **carboplatin**.
  • The patient's disease should not have worsened after the chemotherapy, meaning they have a **complete response (CR)**, **partial response (PR)**, or **stable disease (SD)**.
  • The patient must provide a signed and dated **informed consent**, showing they understand the study details.
  • A **plasma sample** must be provided before the 4th cycle of chemotherapy.
  • The patient should be willing and able to attend scheduled visits and follow the treatment and testing plans.
  • The patient must be at least **18 years old**.
  • The patient should have an estimated life expectancy of at least **3 months**.
  • The patient must have an **ECOG performance status** of 0 or 1, which measures their ability to perform daily activities.
  • The patient should have adequate **bone marrow function**, which includes having enough white blood cells, platelets, and hemoglobin.
  • The patient must have adequate **renal function**, meaning their kidneys are working well enough.
  • The patient should have adequate **liver function**, with certain liver enzymes and bilirubin levels within acceptable limits.
  • If the patient is male and can father children, or if the patient is a female who can become pregnant, they must agree to use two effective methods of **contraception** during the study and for at least 90 days after the last treatment.

Who cannot join the trial?

5 criteria

  • Patients who have a type of cancer called urothelial cancer or bladder cancer that has spread to other parts of the body or cannot be removed by surgery.
  • Patients whose cancer has not gotten worse after finishing their first treatment with a specific type of chemotherapy that contains platinum.
  • Patients who are not in the age range specified for the study.
  • Patients who are not male or female, as both genders are included in the study.
  • Patients who belong to a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Avelumab is a medication used in this trial to help improve the survival of patients with advanced or metastatic urothelial cancer. It is given to patients whose cancer did not worsen after receiving initial chemotherapy that included platinum. The goal is to see if using Avelumab for a short period can help patients live longer.

What is already known about the treatment

Avelumab – Avelumab is administered as an intravenous infusion, typically given in a healthcare setting. It is currently being studied in clinical trials for its effectiveness in treating urothelial cancer, including bladder cancer and muscle-invasive bladder cancer. The main therapeutic indication for Avelumab is to increase overall survival in patients with advanced or metastatic urothelial cancer who have not progressed after initial chemotherapy. At the molecular level, Avelumab works by blocking a protein called PD-L1, which helps cancer cells evade the immune system. This action allows the immune system to better recognize and attack cancer cells. Avelumab is classified as an immune checkpoint inhibitor, a type of immunotherapy.

Investigated diseases

  • Urothelial Cancer

    Urothelial cancer is a type of cancer that begins in the urothelial cells lining the bladder and other parts of the urinary tract. It is the most common type of bladder cancer and can also occur in the ureters and urethra. The disease often starts in the inner lining of the bladder and can progress to invade deeper layers and spread to other parts of the body. Symptoms may include blood in the urine, frequent urination, and pain during urination. As the cancer advances, it may cause more severe symptoms and complications. Early detection is crucial for managing the disease effectively.

  • Bladder Cancer, Muscle Invasive Bladder Cancer

    Bladder cancer occurs when abnormal cells in the bladder grow uncontrollably. Muscle invasive bladder cancer is a more advanced form where the cancer has spread into the muscle layer of the bladder wall. This type of cancer is more aggressive and has a higher chance of spreading to other parts of the body. Symptoms can include blood in the urine, pelvic pain, and changes in urination habits. The progression of the disease can lead to more severe symptoms and complications. Early diagnosis and monitoring are important for managing the condition.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-512975-11-01Protocol codeNL75848.056.20Estimated enrolment121 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).