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Study on the Effectiveness of Ipilimumab and Nivolumab for Patients with Bladder Cancer

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

This clinical trial is focused on studying a type of cancer called bladder cancer, specifically a form known as urothelial carcinoma of the bladder. The study is investigating the effectiveness of a combination of two medications, nivolumab and ipilimumab, which are types of drugs known as monoclonal antibodies. These medications are designed to help the immune system recognize and attack cancer cells more effectively. In this study, patients will receive these medications through an intravenous infusion, which means the drugs are given directly into a vein.

The purpose of the study is to see how well this combination treatment works in keeping the bladder intact and free from cancer events, such as the cancer coming back or spreading. After receiving the combination of nivolumab and ipilimumab, patients will undergo a treatment called chemoradiation, which combines chemotherapy and radiation therapy to target the tumor. The study aims to determine if this approach can help patients avoid more invasive procedures like surgery to remove the bladder.

Throughout the study, researchers will monitor various outcomes, including how long patients live without the cancer returning, the overall survival of patients, and the safety of the treatment. They will also assess the quality of life and bladder function of participants. The study is expected to continue until 2027, with the goal of providing valuable information on the potential benefits of this treatment approach for patients with bladder cancer.

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

    Joining the study

    Upon joining the study, you will be required to provide informed consent, confirming your understanding and willingness to participate in the clinical trial.

    You must ensure the use of highly effective contraception if there is a risk of conception. Female participants of childbearing potential will need to comply with specific contraception methods as outlined in the study protocol.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes verifying that you are at least 18 years old and have urothelial bladder cancer, specifically cT2-4aN0-2M0, and are seeking an alternative to radical cystectomy or are medically unfit for surgery.

    A negative pregnancy test is required for female participants of childbearing potential within two weeks prior to the start of immunotherapy.

  3. Step 3

    Immunotherapy treatment

    You will receive a combination of two medications: nivolumab and ipilimumab. These are administered through an intravenous infusion, which means they are given directly into your vein.

    The specific dosage, frequency, and duration of administration will be determined by the study protocol and your healthcare provider.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, regular monitoring will be conducted to assess your response to the treatment and to ensure your safety. This may include physical examinations, blood tests, and imaging studies.

    You will be evaluated for any potential side effects or adverse reactions to the medications.

  5. Step 5

    Chemoradiation therapy

    Following the immunotherapy phase, you may proceed to chemoradiation therapy, which involves the use of chemotherapy in combination with radiation to target the tumor.

    The feasibility of proceeding to this stage will be assessed based on your response to the initial treatment.

  6. Step 6

    Final evaluation

    At the end of the trial, a final evaluation will be conducted to determine the effectiveness of the treatment in maintaining bladder function and preventing recurrence of cancer.

    Your overall survival, recurrence-free survival, and quality of life will be assessed as part of the study's secondary endpoints.

Who can join the trial?

16 criteria

  • Willing and able to provide informed consent.
  • Use of highly effective contraception for both male and female participants if there is a risk of conception. Female participants who can become pregnant must follow contraception methods as required by the study.
  • Age must be 18 years or older.
  • Have urothelial bladder cancer at stages cT2-4aN0-2M0, looking for an alternative to major bladder surgery or not fit for surgery. Participants with suspected spread of cancer to other parts of the body are not eligible.
  • Cancer spread to lymph nodes should be treatable with radiation according to the medical team.
  • Have a World Health Organization (WHO) performance status of 0 or 1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
  • The main type of cancer must be urothelial cancer (more than 70%). A small cell type of cancer is not allowed.
  • Availability of tumor samples preserved in a specific way (formalin-fixed paraffin-embedded) from a previous diagnostic procedure.
  • Screening blood tests must meet specific criteria:
    • White blood cells (WBC) ≥ 2.0x109/L
    • Neutrophils ≥ 1.0x109/L
    • Platelets ≥ 100x109/L
    • Hemoglobin ≥ 5.5 mmol/L
    • Kidney function (GFR) > 30 ml/min
    • Liver enzymes (AST and ALT) ≤ 2.5 times the upper limit of normal (ULN)
    • Bilirubin ≤ 1.5 times the ULN, except for patients with Gilbert’s syndrome where it can be ≤ 2 times the ULN
    • Negative pregnancy test for female participants who can become pregnant, done within 2 weeks before starting immunotherapy.

Who cannot join the trial?

10 criteria

  • Patients with a history of other types of cancer, except for those who have been cancer-free for at least 5 years.
  • Patients who have had a previous treatment with the drugs ipilimumab or nivolumab.
  • Patients with an active infection that requires treatment with antibiotics.
  • Patients with an autoimmune disease, which is when the body's immune system attacks its own healthy cells.
  • Patients who are pregnant or breastfeeding.
  • Patients with a known allergy to any of the study drugs.
  • Patients who have received another investigational drug within the last 4 weeks.
  • Patients with a serious heart condition, such as heart failure or a recent heart attack.
  • Patients with uncontrolled high blood pressure.
  • Patients with a history of severe lung disease.
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Investigated drugs

  • Ipilimumab

    is a type of medication known as an immune checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells more effectively. In this trial, ipilimumab is used to help treat bladder cancer by boosting the body's natural defenses to fight the cancer.

  • Nivolumab

    is another immune checkpoint inhibitor that helps your immune system target and destroy cancer cells. It is used in combination with ipilimumab in this trial to enhance the immune response against bladder cancer, aiming to improve the chances of keeping the bladder intact and preventing the cancer from coming back.

What is already known about the treatment

  • Ipilimumab

    Ipilimumab is administered through an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating bladder cancer, specifically urothelial carcinoma. The main therapeutic use of ipilimumab is to help the immune system attack cancer cells. It works by blocking a protein called CTLA-4, which normally helps keep immune cells in check, thereby boosting the body's immune response against cancer. Ipilimumab is classified as an immune checkpoint inhibitor, a type of immunotherapy.

  • Nivolumab

    Nivolumab is also given as an intravenous infusion, allowing it to enter the bloodstream directly. It is being researched in clinical trials for its potential to treat bladder cancer, particularly urothelial carcinoma. The primary therapeutic purpose of nivolumab is to enhance the immune system's ability to fight cancer. It achieves this by inhibiting a protein called PD-1, which can prevent immune cells from attacking cancer cells, thus promoting a stronger immune response. Nivolumab is categorized as an immune checkpoint inhibitor, a form of immunotherapy.

Investigated diseases

Urothelial Carcinoma of the Bladder – Urothelial carcinoma of the bladder is a type of cancer that begins in the urothelial cells lining the bladder. These cells are responsible for stretching as the bladder fills and contracts. The disease often starts as a superficial tumor on the bladder wall and can progress to invade deeper layers of the bladder muscle. As it advances, it may spread to nearby lymph nodes and other organs. The progression can lead to symptoms such as blood in the urine, frequent urination, and pain during urination. Over time, the cancer may metastasize to distant parts of the body, affecting overall health and bladder function.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-512211-41-00Protocol codeM21IDBEstimated enrolment50 patientsSponsorHet Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

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