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Study of Sasanlimab Treatment as a Bladder-Sparing Strategy in Patients with Muscle Invasive Bladder Cancer

Fast replyInvestigationalNo 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 bladder cancer known as muscle-invasive bladder cancer. The trial is exploring a treatment strategy that aims to preserve the bladder in patients who have this type of cancer. The treatment being tested is called sasanlimab, which is a special kind of medicine known as a monoclonal antibody. Monoclonal antibodies are proteins designed to target specific parts of cancer cells. In this study, sasanlimab is given as a solution for injection under the skin.

The purpose of the study is to evaluate how well patients do when their bladder is left intact after receiving sasanlimab. The study will follow patients for 12 months after they start the treatment to see how many are alive and have not needed surgery to remove the bladder, known as a cystectomy. Patients will receive sasanlimab after they have already undergone a type of chemotherapy called neoadjuvant therapy, which is given before the main treatment to shrink the tumor. The study will also look at other outcomes, such as the response to treatment, survival without the cancer spreading, and overall survival.

Participants in the study will receive regular injections of sasanlimab and will be monitored closely by healthcare professionals. The study will also assess the quality of life of participants using a questionnaire designed to understand how the treatment affects their daily lives. The trial aims to provide valuable information on whether sasanlimab can be an effective treatment option for preserving the bladder in patients with muscle-invasive bladder 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

    Initiation of treatment

    The treatment begins with the administration of sasanlimab, a medication used to treat muscle-invasive bladder cancer. This medication is given as a solution for injection under the skin, known as subcutaneous use.

    The primary goal is to evaluate the survival rate with the bladder intact at 12 months after the first dose of sasanlimab.

  2. Step 2

    Treatment administration

    Sasanlimab is administered regularly as part of the treatment plan. The frequency and exact schedule of administration will be determined by the healthcare provider based on individual response and treatment protocol.

  3. Step 3

    Monitoring and evaluation

    Throughout the trial, regular monitoring will occur to assess the clinical response to the treatment. This includes checking for the absence of muscle-invasive cancer after cisplatin-based treatment.

    Health-related quality of life will be assessed using a specific questionnaire designed to evaluate the impact of the treatment on daily life.

  4. Step 4

    Follow-up and assessment

    The primary endpoint is the percentage of patients who are alive and have not undergone cystectomy at 12 months after the first dose of sasanlimab.

    Secondary endpoints include disease-free survival, metastasis-free survival, and overall survival, along with the frequency and severity of any adverse events related to the treatment.

  5. Step 5

    Completion of trial

    The trial is estimated to conclude by January 15, 2027. At this point, a comprehensive analysis of the data collected will be conducted to determine the effectiveness and safety of sasanlimab as a bladder-sparing treatment strategy.

Who can join the trial?

14 criteria

  • Patients must sign a written informed consent to participate in the trial.
  • Female patients must agree not to breastfeed or donate eggs during the study and for at least 6 months after the last dose of the study drug.
  • Male patients with partners who can become pregnant, or who are pregnant or breastfeeding, must agree to abstain from sex or use a condom plus another form of highly effective birth control during the study and for at least 6 months after the last dose of the study drug.
  • Male patients must not donate sperm during the study and for at least 6 months after the last dose of the study drug.
  • Patients must be willing and able to attend scheduled visits, follow the treatment plan, and undergo laboratory tests and other study procedures.
  • Patients must agree not to participate in another interventional study while receiving treatment in this study.
  • Patients must be at least 18 years old at the time of giving consent.
  • Patients must have an ECOG Performance Status of 0 or 1, which means they are fully active or have some symptoms but do not need to stay in bed for more than half of the day.
  • Patients must have histological evidence, meaning tissue samples showing localized muscle-invasive urothelial cancer of the bladder, and be candidates for bladder removal surgery as determined by their doctor.
  • Patients must not have cancer that has spread to other parts of the body, confirmed by a CT or MRI scan of the pelvis, abdomen, and chest within 4 weeks before joining the study.
  • Patients must be candidates to receive a specific type of chemotherapy called neoadjuvant therapy with gemcitabine and cisplatin. Another treatment called MVAC is not allowed.
  • Patients must have enough stored tissue samples available at the start of the study. If not, they must discuss this with the study doctor.
  • Patients must have adequate organ and bone marrow function, which includes specific levels of blood cells, kidney function, and liver enzymes.
  • Female patients must either be unable to have children (due to menopause or surgical procedures) or, if they can have children, agree not to become pregnant during the study and for at least 6 months after the last dose of the study drug. They must also have a negative pregnancy test before starting the study and use effective birth control if sexually active.

Who cannot join the trial?

10 criteria

  • Patients who have had another type of cancer in the past, unless it was a very early stage and has been completely treated.
  • Patients who have serious heart problems, such as heart failure or a recent heart attack.
  • Patients who have uncontrolled high blood pressure.
  • Patients who have an active infection that requires treatment with antibiotics.
  • Patients who have a known allergy to the study medication or similar drugs.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse that could interfere with the study.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have had a major surgery within the last 4 weeks.
  • Patients who have a condition that affects their immune system, like HIV.
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Investigated drugs

Sasanlimab is a medication being studied as a maintenance treatment for patients with muscle invasive bladder cancer. It is used after initial treatment to help keep the cancer from coming back. The goal of using sasanlimab in this trial is to see if it can help patients live longer without needing to remove the bladder or experiencing cancer progression.

What is already known about the treatment

Sasanlimab – Sasanlimab is administered as an injection, typically given under the skin. It is currently being studied in clinical trials for its effectiveness in treating muscle invasive bladder cancer, specifically in patients whose cancer has been categorized at the molecular level. The main therapeutic indication for sasanlimab is to maintain bladder function and improve survival rates without the need for bladder removal surgery. At the molecular level, sasanlimab works by targeting specific proteins involved in cancer cell growth, helping to slow or stop the progression of the disease. It is classified as an immunotherapy agent, which means it helps the body's immune system fight cancer.

Investigated diseases

Muscle Invasive Bladder Cancer – This is a type of bladder cancer where the cancer cells have spread into the muscle layer of the bladder wall. It is more aggressive than non-muscle invasive bladder cancer and can progress to affect other parts of the body if not managed. The disease often begins with symptoms such as blood in the urine, frequent urination, or pain during urination. As it progresses, it may cause more severe symptoms and can lead to complications if the cancer spreads beyond the bladder. The progression of the disease can vary, with some cases advancing more rapidly than others. Understanding the molecular characteristics of the cancer can help in determining the best approach for management.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511358-36-00Protocol code‭HM-87884561Estimated enrolment70 patientsSponsorFundacion De investigacion De Hm Hospitales

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