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Study of Livmoniplimab and Budigalimab Compared to Chemotherapy for Adults with Advanced 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 Metastatic Urothelial Carcinoma, which is a cancer that affects the bladder and other parts of the urinary system. The study is testing a new combination of treatments to see how effective they are compared to standard chemotherapy. The treatments being tested are called Livmoniplimab and Budigalimab. These are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to find the best dose of Livmoniplimab when used with Budigalimab and to see how well this combination works in patients who have already tried other treatments. The study will compare the new combination to traditional chemotherapy drugs, which include Paclitaxel, Docetaxel, and Gemcitabine. These chemotherapy drugs are also given through an intravenous infusion. The study will help determine if the new combination can improve the overall survival of patients, which means living longer without the cancer getting worse.

Participants in the study will receive either the new combination of Livmoniplimab and Budigalimab or one of the standard chemotherapy treatments. The study will last for up to 24 months, during which time the health of the participants will be closely monitored. The goal is to see if the new treatment can help patients live longer and have a better quality of life compared to the standard chemotherapy options. This study is important for finding new ways to treat Metastatic Urothelial Carcinoma and potentially improve outcomes for patients with this type of cancer.

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

    Joining the study

    Upon joining the study, the participant will be randomly assigned to one of two groups: one receiving a combination of livmoniplimab and budigalimab, and the other receiving chemotherapy.

    The study is designed to assess the effectiveness of these treatments in individuals with metastatic urothelial carcinoma.

  2. Step 2

    Treatment administration

    Participants in the first group will receive livmoniplimab and budigalimab through an intravenous infusion. The dosage and frequency will be determined based on the optimization of the livmoniplimab dose.

    Participants in the chemotherapy group will receive one of the following medications through intravenous infusion: paclitaxel, docetaxel, or gemcitabine. The specific medication, dosage, and frequency will be determined by the study protocol.

  3. Step 3

    Monitoring and assessments

    Throughout the study, participants will undergo regular monitoring to assess the effectiveness of the treatment. This includes measuring overall survival, progression-free survival, and the best overall response.

    Participants will also be monitored for any side effects or adverse reactions to the treatment.

  4. Step 4

    Completion of the study

    The study is expected to continue until September 2028. Participants will be followed up until the end of the study to gather comprehensive data on the treatment's effectiveness and safety.

    The primary endpoint is overall survival, while secondary endpoints include progression-free survival, best overall response, and duration of response.

Who can join the trial?

7 criteria

  • The participant must have a confirmed diagnosis of **urothelial carcinoma**, which is a type of cancer that affects the bladder, renal pelvis, ureter, or urethra. If the cancer has different types of cells, the main type should be **urothelial (transitional cell)**.
  • The participant must have **metastatic disease**, meaning the cancer has spread to other parts of the body, as shown by medical imaging.
  • The participant must have experienced cancer progression or return after treatment with a **checkpoint inhibitor**. This is a type of drug that helps the immune system fight cancer. The participant must have received at least 2 cycles of this treatment.
  • If the participant is eligible for **platinum-based treatment** (a type of chemotherapy), they must have received it in the past. This includes drugs like **cisplatin** or **carboplatin**. If this treatment was given before or after surgery, the cancer must have progressed within 6 months after finishing the treatment. If the participant cannot receive platinum-based treatment, they can still join the study without having had it.
  • The participant must have at least one **measurable lesion**. This means there is a tumor that can be measured to see if it changes in size during the study.
  • The participant must have a **life expectancy** of at least 3 months.
  • The study is open to both male and female participants.

Who cannot join the trial?

3 criteria

  • Patients who have not progressed on previous treatment with a checkpoint inhibitor. A checkpoint inhibitor is a type of drug that helps the immune system fight cancer.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Livmoniplimab

    is an investigational medication being studied for its potential to treat metastatic urothelial carcinoma. It is being tested to find the best dose when used in combination with another medication, budigalimab. The goal is to see if this combination can help patients who have not responded to previous treatments.

  • Budigalimab

    is another investigational medication used in this study. It is combined with livmoniplimab to see if together they can improve the survival of patients with metastatic urothelial carcinoma. Researchers are looking to determine the most effective dose for future studies.

What is already known about the treatment

  • Livmoniplimab

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating metastatic urothelial carcinoma. It is not yet widely used in standard medical practice, as it is still under investigation. The main therapeutic indication is for patients with metastatic urothelial carcinoma who have not responded to previous treatments. Livmoniplimab works by targeting specific proteins on cancer cells, helping the immune system to recognize and attack these cells. It is classified as an immunotherapy agent.

  • Budigalimab

    This medication is also administered intravenously and is being evaluated in clinical trials alongside livmoniplimab for the treatment of metastatic urothelial carcinoma. It is not yet approved for general medical use. The primary therapeutic indication is for patients with metastatic urothelial carcinoma who have progressed after previous treatments. Budigalimab functions by inhibiting certain immune checkpoints, thereby enhancing the body's immune response against cancer cells. It falls under the category of monoclonal antibodies used in cancer immunotherapy.

Investigated diseases

  • Metastatic Urothelial Carcinoma

    This is a type of cancer that begins in the urothelial cells lining the bladder and can spread to other parts of the body. As it progresses, the cancer cells invade nearby tissues and organs, potentially reaching distant sites such as the liver, lungs, or bones. The disease often advances after initial treatments, requiring further therapeutic strategies to manage its spread and symptoms.

  • Urothelial Carcinoma

    This cancer originates in the urothelial cells that line the inside of the bladder, ureters, and parts of the kidneys. It typically starts in the bladder and can grow into the bladder wall or spread to nearby lymph nodes and organs. The progression of the disease can vary, with some cases remaining localized while others may become more aggressive and spread to other areas of the body.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515506-11-00Protocol codeM25-204Estimated enrolment158 patientsSponsorAbbVie Deutschland GmbH & Co. KG

sourced from the EU Clinical Trials Register and site verification

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