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Study on Nivolumab and Ipilimumab for Patients with Untreated Unresectable or Metastatic Urothelial 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 treatments for urothelial cancer, a type of cancer that affects the bladder and other parts of the urinary system. The study involves participants who have not received prior treatment for their cancer, which is either not removable by surgery or has spread to other parts of the body. The trial will test the effectiveness of a combination of two medications, nivolumab and ipilimumab, compared to standard chemotherapy treatments. Chemotherapy is a common cancer treatment that uses drugs to kill cancer cells. The medications nivolumab and ipilimumab are given as infusions, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to compare how well patients live with the combination of nivolumab and ipilimumab versus standard chemotherapy. The study will also look at how these treatments affect patients who cannot receive a specific chemotherapy drug called cisplatin, and those whose cancer cells have a protein called PD-L1. PD-L1 is a protein that can help cancer cells hide from the immune system. The study will involve regular visits to the clinic for treatment and monitoring, and participants will receive either the combination of nivolumab and ipilimumab or standard chemotherapy, which may include drugs like carboplatin, cisplatin, or gemcitabine.

Participants will be randomly assigned to one of the treatment groups, and some may receive a placebo, which is a substance with no active medication. The study will continue for a period of time to observe the effects of the treatments on overall survival and quality of life. The results of this study will help determine the best treatment options for patients with untreated, unresectable, or metastatic urothelial 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

    Enrollment and initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the presence of metastatic or inoperable urothelial cancer and ensuring no prior systemic chemotherapy treatment in the metastatic setting.

    The assessment also checks for at least one measurable lesion and evaluates the ability to perform light activities.

  2. Step 2

    Treatment group assignment

    Participants are randomly assigned to one of the treatment groups: nivolumab combined with ipilimumab, nivolumab with standard chemotherapy, or standard chemotherapy alone.

  3. Step 3

    Nivolumab and ipilimumab administration

    For those receiving nivolumab and ipilimumab, nivolumab is administered as a solution for infusion at a concentration of 10 mg/mL. Ipilimumab is also given as a solution for infusion at a concentration of 5 mg/mL.

    Both medications are delivered through intravenous use.

  4. Step 4

    Standard chemotherapy administration

    Participants in the standard chemotherapy group receive medications such as carboplatin, cisplatin, and gemcitabine. These are administered as solutions for infusion or injections through intravenous use.

    The specific regimen and dosage depend on the assigned treatment plan.

  5. Step 5

    Monitoring and follow-up

    Throughout the trial, regular monitoring is conducted to assess the treatment's effectiveness and any side effects. This includes imaging studies and health status evaluations.

    Participants are followed up until the estimated end date of the trial in December 2025.

Who can join the trial?

6 criteria

  • Have **metastatic** or **inoperable urothelial cancer**. This means the cancer has spread to other parts of the body or cannot be removed by surgery.
  • Must have at least one **lesion** with measurable disease. A lesion is an area of abnormal tissue that can be measured to see if it changes during the study.
  • Must have full activity or, if limited, must be able to walk and carry out light activities such as light housework or office work. This means you should be able to do most daily activities on your own.
  • No prior **systemic chemotherapy** treatment in the metastatic setting. This means you should not have received chemotherapy that affects the whole body for cancer that has spread.
  • Both males and females can participate.
  • Participants should not be from a vulnerable population, meaning they should be able to give informed consent and understand the study.

Who cannot join the trial?

14 criteria

  • Patients who have already received treatment for their urothelial cancer cannot participate.
  • Patients with cancer that can be surgically removed are not eligible.
  • Patients who are eligible for a specific chemotherapy drug called cisplatin cannot join the study.
  • Patients with other serious health conditions that could interfere with the study treatment are excluded.
  • Patients who have had another type of cancer in the past, unless it was successfully treated and is not expected to come back, cannot participate.
  • Patients who are pregnant or breastfeeding are not eligible.
  • Patients who have an active infection that requires treatment with antibiotics cannot join the study.
  • Patients who have received a live vaccine within 30 days before the start of the study treatment are excluded.
  • Patients with a known allergy to the study drugs or similar drugs cannot participate.
  • Patients who have a condition that affects their immune system, such as HIV, are not eligible.
  • Patients who are taking medications that suppress the immune system, like steroids, cannot join the study.
  • Patients who have had a major surgery within 4 weeks before the start of the study treatment are excluded.
  • Patients who have a history of drug or alcohol abuse that could interfere with the study are not eligible.
  • Patients who are unable to comply with the study procedures and follow-up visits cannot participate.
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Investigated drugs

  • Nivolumab

    is a medication used in this trial to help the body's immune system fight cancer. It works by blocking a protein that stops the immune system from attacking cancer cells, allowing the immune system to better target and destroy them.

  • Ipilimumab

    is another medication used in combination with nivolumab in this trial. It also helps the immune system attack cancer cells by blocking a different protein that can slow down the immune response. Together with nivolumab, it aims to enhance the body's ability to fight cancer.

  • Standard of Care Chemotherapy

    refers to the usual treatment given for urothelial cancer, which involves using drugs to kill or stop the growth of cancer cells. In this trial, it is used as a comparison to see how well the combination of nivolumab and ipilimumab works against the standard treatment.

What is already known about the treatment

  • Nivolumab

    Nivolumab is administered as an intravenous infusion. It is currently being studied in clinical trials for its effectiveness in treating previously untreated, unresectable, or metastatic urothelial cancer. The main therapeutic indication is for patients with this type of cancer who are ineligible for cisplatin treatment. Nivolumab works by blocking a protein called PD-1 on immune cells, which helps the immune system attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor.

  • Ipilimumab

    Ipilimumab is also given through an intravenous infusion. It is being evaluated in combination with nivolumab in clinical trials for its potential to improve survival in patients with untreated, unresectable, or metastatic urothelial cancer. The primary therapeutic use is for enhancing the immune response against cancer cells. Ipilimumab functions by targeting CTLA-4, a protein receptor that downregulates the immune system, thereby boosting the body's ability to fight cancer. It belongs to the class of immune checkpoint inhibitors.

Investigated diseases

Urothelial Cancer – Urothelial cancer is a type of cancer that typically begins in the cells lining the bladder, but it can also occur in other parts of the urinary tract. It is characterized by the abnormal growth of cells in the urothelium, which can form tumors. When untreated, it can become unresectable, meaning it cannot be removed surgically, or metastatic, meaning it has spread to other parts of the body. The progression of the disease can vary, with some cases remaining localized while others spread more aggressively. Factors such as the cancer's stage and grade can influence its behavior and progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501784-40-00Protocol codeCA209-901Estimated enrolment1 777 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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