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Study of Izalontamab Brengitecan Compared to Platinum-Based Chemotherapy for Patients with Metastatic Urothelial Cancer After Immunotherapy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at metastatic urothelial cancer, which is a cancer that started in the lining of the bladder or urinary tract and has spread to other parts of the body. The study will test a medicine called izalontamab brengitecan, which is also known by its code name BMS986507. This medicine will be compared to standard chemotherapy treatments that use platinum-based drugs. The platinum-based chemotherapy includes either cisplatin or carboplatin, which are given together with gemcitabine. The study also uses pegfilgrastim, which is a supportive medicine that helps protect the body during chemotherapy treatment.

The purpose of the study is first to find the right dose of izalontamab brengitecan to use, and then to see how well this medicine works compared to platinum-based chemotherapy in people whose cancer has gotten worse during or after treatment with immunotherapy. The study is designed for people who have already received immunotherapy treatment and whose cancer has continued to grow or spread despite this treatment. Participants in this study must be able to receive platinum-based chemotherapy and should not have had more than two previous types of treatment for their cancer that has spread.

The study will be done in two phases. In the first phase, researchers will determine the best dose of izalontamab brengitecan by looking at how safe it is and how well it works. In the second phase, participants will be randomly assigned to receive either izalontamab brengitecan or platinum-based chemotherapy, and the two treatments will be compared. The study will measure how long it takes for the cancer to get worse, how long participants live, how many people respond to treatment, and how long those responses last. The study will also look at how the treatments affect quality of life.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Random assignment to treatment group

    Upon joining the trial, you will be randomly assigned to one of two treatment groups. This process is similar to flipping a coin and ensures fairness in the study.

    One group will receive izalontamab brengitecan (also called iza-bren), and the other group will receive platinum-based chemotherapy (also called PBC), which includes drugs such as cisplatin or carboplatin combined with gemcitabine.

  2. Step 2

    Treatment with izalontamab brengitecan (if assigned to this group)

    If you are assigned to the izalontamab brengitecan group, you will receive this medication through an intravenous infusion, which means it will be given directly into your vein.

    The trial includes two phases. In Phase 2, the appropriate dose of iza-bren will be determined. In Phase 3, this established dose will be used to compare the effectiveness of the treatment.

    The specific dosage, frequency, and duration of treatment with iza-bren will be determined by the trial protocol and your response to the medication.

  3. Step 3

    Treatment with platinum-based chemotherapy (if assigned to this group)

    If you are assigned to the platinum-based chemotherapy group, you will receive a combination of medications through intravenous infusion, meaning they will be given directly into your vein.

    The treatment may include cisplatin or carboplatin combined with gemcitabine. The choice between cisplatin and carboplatin will depend on your ability to tolerate these medications.

    You may also receive pegfilgrastim as a subcutaneous injection, which means it will be given under your skin. This medication helps your body produce white blood cells and may reduce the risk of infections during chemotherapy.

    The specific dosage, frequency, and duration of each medication will be determined by the trial protocol.

  4. Step 4

    Regular monitoring and assessments

    Throughout the trial, you will undergo regular assessments to monitor how the treatment is working and to check for any side effects.

    These assessments will include measurements of progression-free survival, which refers to the time from the start of treatment until your disease worsens or death occurs, whichever comes first.

    Your overall survival, meaning how long you live, will also be tracked.

    Other measurements will include the objective response rate, which shows what proportion of patients respond to treatment, time to response, which indicates how long it takes for you to respond to treatment, and duration of response, which measures how long your response to treatment lasts.

  5. Step 5

    Quality of life assessments (Phase 3 only)

    If you are participating in Phase 3 of the trial, you will be asked to complete questionnaires about your quality of life.

    These assessments will measure the time it takes for you to report a decline in your quality of life, and the results will be compared between the two treatment groups.

  6. Step 6

    Safety and tolerability monitoring

    Throughout the trial, your safety will be closely monitored. This includes checking for any side effects or adverse reactions to the medications.

    Information about the safety and tolerability of the treatments will be collected and reviewed regularly.

    In Phase 2, this information will help determine the recommended dose of iza-bren for Phase 3.

  7. Step 7

    Continuation of treatment

    You will continue to receive your assigned treatment according to the trial protocol.

    The duration of your participation in the trial will depend on how your disease responds to treatment and your overall health.

    The trial is estimated to continue until October 2029, though your individual participation may be shorter or longer depending on your specific circumstances.

Who can join the trial?

8 criteria

  • You must have metastatic urothelial cancer, which means cancer that started in the lining of the bladder or urinary tract and has spread to other parts of the body. This must be confirmed by examining tissue or cell samples under a microscope.
  • Your cancer must have gotten worse during or after treatment with immunotherapy, which is a type of medicine that helps your body's immune system fight cancer cells.
  • You must not have received more than two different types of systemic cancer treatment before joining this study. Systemic treatment means medicine that travels through your bloodstream to reach cancer cells throughout your body.
  • Your cancer must have grown or returned after being treated with anti-PD-(L)1 therapy, which is a specific type of immunotherapy. This therapy could have been used alone or combined with other treatments, but you must have received at least one other treatment in addition to it. However, if you only received this therapy for bladder cancer that had not spread to other parts of your body, you cannot participate.
  • If you received anti-PD-(L)1 therapy before or after surgery, you may still be eligible if certain other conditions are met.
  • You must be able to receive treatment with platinum-based chemotherapy, which includes medicines called cisplatin or carboplatin. These are strong cancer-fighting drugs that contain platinum.
  • You can be male or female to participate in this study.
  • You must be an adult to participate in this study.

Who cannot join the trial?

3 criteria

  • The source data does not provide specific exclusion criteria (reasons why patients cannot participate) for this clinical trial
  • Without detailed exclusion criteria information, it is not possible to list the specific conditions or situations that would prevent participation in this study
  • Exclusion criteria typically include factors such as other health conditions, previous treatments, or test results that might make the study unsafe or affect the results, but these specific details are not available in the provided information
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Investigated drugs

  • Izalontamab Brengitecan

    is an investigational medication being tested in this trial. It is designed to treat metastatic urothelial cancer, which is a type of cancer that affects the bladder and urinary tract and has spread to other parts of the body. This medication is being studied to see if it can help patients whose cancer has gotten worse after receiving immunotherapy treatment.

  • Platinum-based chemotherapy

    refers to a group of cancer-fighting medications that contain platinum. These medications work by damaging cancer cells to stop them from growing and multiplying. Platinum-based chemotherapy is a standard treatment option for urothelial cancer and is being used as a comparison treatment in this trial to see how well the investigational medication works.

What is already known about the treatment

Izalontamab Brengitecan – Izalontamab Brengitecan is an investigational cancer treatment currently being studied in clinical trials for patients with metastatic urothelial cancer (a type of bladder cancer that has spread to other parts of the body) who have not responded to immunotherapy treatments. This medication is administered as an infusion into the bloodstream and works by targeting specific proteins on cancer cells, delivering a toxic substance directly to the tumor to destroy it while minimizing damage to healthy cells. The drug is still in the research phase (Phase 2/3 trials) and is being compared to standard platinum-based chemotherapy to determine if it is more effective and what the best dose should be for treating this type of advanced cancer.

Investigated diseases

Metastatic Urothelial Cancer – This is a type of cancer that begins in the urothelial cells, which line the urinary system including the bladder, ureters, and parts of the kidneys. The term "metastatic" means that the cancer has spread from its original location to other parts of the body through the bloodstream or lymphatic system. As the disease progresses, cancer cells can travel to distant organs such as the lungs, liver, bones, or lymph nodes. Patients may experience symptoms such as blood in urine, frequent urination, pain during urination, back pain, or weight loss. The cancer develops when urothelial cells undergo abnormal changes and begin to grow uncontrollably, forming tumors. In its metastatic stage, the disease has advanced beyond the local area where it first developed and has established new tumor sites in other body regions.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2025-522400-24-00Protocol codeCA2440012Estimated enrolment461 patientsSponsorBristol-Myers Squibb Services Unlimited Company

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