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Study Comparing Nivolumab to Placebo for Patients with High-Risk Invasive Bladder Cancer

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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 Invasive Urothelial Carcinoma, which is a cancer that affects the bladder and other parts of the urinary system. The study is comparing a treatment using a medication called Nivolumab with a placebo. Nivolumab is a type of medication that is given through an infusion, which means it is delivered directly into the bloodstream through a vein. The purpose of the study is to see how well Nivolumab works in preventing the cancer from coming back after surgery.

Participants in the study will be randomly assigned to receive either Nivolumab or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication and who is receiving the placebo. This helps ensure that the results are not biased. The study will take place over a period of time, and participants will receive regular infusions and check-ups to monitor their health and the status of their cancer.

The main goal of the study is to compare the time participants remain free of cancer between those receiving Nivolumab and those receiving the placebo. Additionally, the study will look at other outcomes, such as how long participants live without the cancer spreading to other parts of the body and overall survival rates. This research aims to provide valuable information on the effectiveness of Nivolumab in treating high-risk Invasive Urothelial Carcinoma.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    Upon joining the study, you will be randomly assigned to one of two groups. One group will receive the medication nivolumab, and the other group will receive a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual drug.

  2. Step 2

    Treatment administration

    If you are in the group receiving nivolumab, you will be given the medication through an intravenous infusion. This means the medication will be delivered directly into your bloodstream through a vein. The dosage is 10 mg/mL, and the frequency and duration of administration will be determined by the study protocol.

    If you are in the placebo group, you will receive an infusion that does not contain the active medication. The process will be the same as for those receiving nivolumab.

  3. Step 3

    Monitoring and follow-up

    Throughout the study, regular check-ups will be conducted to monitor your health and the effects of the treatment. This will include physical examinations and imaging studies to ensure there is no recurrence of the disease.

    You will be required to provide tumor tissue samples for biomarker analysis. This helps in understanding how the treatment is working and its effects on your body.

  4. Step 4

    End of study

    The study is expected to conclude by May 29, 2026. At the end of the study, the results will be analyzed to compare the effectiveness of nivolumab versus the placebo in preventing the recurrence of the disease.

Who can join the trial?

10 criteria

  • Must have had a complete surgical removal of the tumor (called radical surgical resection) for invasive urothelial carcinoma within the last 120 days. If cancer cells are found in the surgical margins, you cannot participate.
  • Must have evidence of urothelial carcinoma, which is a type of cancer that starts in the bladder, ureter, or renal pelvis, and is at high risk of coming back.
  • The main type of cancer cells must be urothelial carcinoma or transitional cell carcinoma. Small areas of different types of cancer cells are allowed.
  • Must be free of disease, meaning no signs of cancer returning, confirmed by a physical exam and imaging tests within 4 weeks before joining the study. Imaging tests include a CT scan of the chest and a CT or MRI of the abdomen and pelvis. If there is a suspicion of brain involvement, a brain MRI or CT scan is needed. If you have low-risk papillary lesions, you can join if these are removed. Intermediate-risk lesions can join if no further treatment is needed.
  • Must provide a sample of tumor tissue from the most recent surgery or from the initial diagnosis for testing. The tumor must have a specific protein level called PD-L1 determined by a central lab.
  • Must have a life expectancy of at least 6 months.
  • Must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, which measures daily living abilities. If you haven't had certain chemotherapy and can't have it, you may join with a status of 2.
  • Any major surgery requiring general anesthesia must be completed at least 4 weeks before starting the study drug. Minor surgeries with local anesthesia must be completed at least 72 hours before. A specific bladder surgery called TURBT must be done 14 days before joining.
  • Must be aged 18 years or older.
  • Both males and females can participate.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer other than **High Risk Invasive Urothelial Carcinoma** cannot participate.
  • Patients who have had another cancer within the last 5 years, except for skin cancer that is not melanoma, cannot participate.
  • Patients who have an active infection that requires treatment with antibiotics, antivirals, or antifungals cannot participate.
  • Patients who have an autoimmune disease, which is when the body's immune system attacks its own cells, cannot participate.
  • Patients who are currently using immunosuppressive therapy, which is treatment that lowers the body's ability to fight infections, cannot participate.
  • Patients who have received a live vaccine within 30 days before the start of the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have a known allergy to the study drug or its ingredients cannot participate.
  • Patients who have a history of severe allergic reactions cannot participate.
  • Patients who have a serious heart condition cannot participate.
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Investigated drugs

Nivolumab is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, nivolumab is being tested to see if it can help prevent the return of cancer in patients who have had surgery for high-risk invasive urothelial carcinoma, a type of bladder cancer. The goal is to see if nivolumab can improve the time patients remain free from cancer compared to those who do not receive the medication.

What is already known about the treatment

Nivolumab – Nivolumab is administered as 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 high-risk invasive urothelial carcinoma, a type of bladder cancer. The main therapeutic use of nivolumab is to help the immune system fight cancer by blocking a protein called PD-1, which can prevent immune cells from attacking cancer cells. This medication is classified as an immune checkpoint inhibitor, a type of drug that helps the body's immune system recognize and destroy cancer cells.

Investigated diseases

Invasive Urothelial Carcinoma – Invasive urothelial carcinoma is a type of cancer that begins in the urothelial cells lining the bladder and can spread into the muscle wall of the bladder. It is characterized by the abnormal growth of cells that can invade nearby tissues and organs. As the disease progresses, it may spread to the lymph nodes and other parts of the body. The cancer cells can express certain proteins, such as PD-L1, which may influence the behavior of the tumor. The progression of the disease can vary, with some tumors growing slowly while others may advance more rapidly. The condition is not classified as a rare disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-500630-29-00Protocol codeCA209-274Estimated enrolment367 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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