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Study on Erdafitinib and Cetrelimab for Patients with Muscle-Invasive Bladder Cancer Ineligible for Cisplatin Treatment

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 cancer called muscle-invasive bladder cancer (MIBC). The study is exploring the effects of two treatments: erdafitinib and cetrelimab. Erdafitinib is a medication taken as a tablet, while cetrelimab is given as an infusion, which means it is administered directly into the bloodstream through a vein. The purpose of the study is to evaluate how effective and safe these treatments are when used alone or in combination, especially for patients who cannot receive a common chemotherapy drug called cisplatin.

Participants in the study will receive either erdafitinib alone or a combination of erdafitinib and cetrelimab. The study will monitor the response of the cancer to these treatments, particularly looking for any reduction in the size of the tumor or complete disappearance of the cancer. The study will also assess the safety of the treatments by keeping track of any side effects experienced by the participants. The trial is designed to help understand if these treatments can be effective options for patients with MIBC who have specific changes in their cancer cells known as FGFR gene alterations.

The study will take place over a period of time, during which participants will receive the treatments and undergo regular check-ups to monitor their health and the progress of the cancer. The goal is to gather information that could lead to new treatment options for patients with muscle-invasive bladder cancer who are not able to use standard chemotherapy. This research is important for developing new ways to manage and treat this type of cancer, potentially improving outcomes for patients in the future.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    Laboratory tests are performed to ensure adequate organ function and to confirm the presence of specific genetic alterations in the tumor.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of erdafitinib and cetrelimab.

    Erdafitinib is taken orally in the form of a film-coated tablet. The dosage and frequency are determined by the study protocol and adjusted based on individual response and tolerance.

    Cetrelimab is administered intravenously as a solution for infusion. The frequency and duration of administration are specified in the study protocol.

  3. Step 3

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to treatment and to identify any side effects. This includes physical examinations, laboratory tests, and imaging studies.

    Adjustments to the treatment regimen may be made based on the results of these assessments.

  4. Step 4

    Surgical evaluation

    Following the treatment phase, a surgical evaluation is performed to determine the extent of the tumor response.

    The primary goal is to achieve a pathological complete response, meaning no evidence of residual disease in the surgical specimen.

  5. Step 5

    Post-treatment follow-up

    After the surgical evaluation, ongoing follow-up is conducted to monitor for any recurrence of the disease and to manage any long-term effects of the treatment.

    This phase includes regular medical check-ups and may involve additional imaging studies or laboratory tests as needed.

Who can join the trial?

10 criteria

  • You must provide written informed consent, which means you understand the study's purpose and agree to participate.
  • You must be willing to avoid pregnancy or fathering children during the study and for a certain period after the last dose of the study drugs. Men must take precautions to avoid fathering children, and women of childbearing potential must have a negative pregnancy test and use effective birth control.
  • You must have a confirmed diagnosis of **muscle-invasive bladder cancer (MIBC)**, which is a type of bladder cancer that has spread into the muscle layer of the bladder wall.
  • Your cancer must be of a specific type called **urothelial carcinoma (UC)**, which makes up at least 50% of the cancer cells.
  • You must be at least 18 years old.
  • You must have a good general health status, as measured by the **Eastern Cooperative Oncology Group (ECOG) performance status** of 0-1, which indicates you are fully active or have some symptoms but do not need bed rest.
  • You must be unable or unwilling to receive a specific type of chemotherapy called **cisplatin-based chemotherapy** due to certain health conditions, such as reduced kidney function, hearing loss, or nerve damage.
  • Your tumor must have a specific genetic change called an **FGFR alteration**, which will be checked through a biopsy sample.
  • Your organs must be functioning well, as shown by specific blood test results, including adequate levels of blood cells, liver function, and kidney function.
  • You must not have any other active cancer, except for certain types of skin cancer, cervical cancer, or low-risk prostate cancer, diagnosed within the last 3 years.

Who cannot join the trial?

4 criteria

  • Patients who have a different type of cancer other than muscle-invasive bladder cancer (MIBC). This is a type of cancer that affects the bladder muscles.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial groups.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Erdafitinib

    is a medication being tested in this trial for its effectiveness and safety as a treatment for patients with muscle-invasive bladder cancer. It is used as a monotherapy, meaning it is given alone without any other cancer treatments. Erdafitinib works by targeting specific genetic changes in cancer cells, known as FGFR gene alterations, which can help stop the growth of cancer cells.

  • Cetrelimab

    is another medication involved in this trial. It is being tested in combination with erdafitinib to see if the two drugs together can be more effective than erdafitinib alone. Cetrelimab is an immunotherapy drug, which means it helps the body's immune system recognize and attack cancer cells. This combination is being studied to see if it can improve treatment outcomes for patients who cannot receive the standard chemotherapy drug, cisplatin.

What is already known about the treatment

  • Erdafitinib

    Erdafitinib is administered orally and is currently being studied in clinical trials for its effectiveness in treating muscle-invasive bladder cancer, particularly in patients who cannot receive cisplatin. It is used as a monotherapy or in combination with cetrelimab. The medication works by inhibiting the fibroblast growth factor receptor (FGFR) pathway, which is involved in cell growth and survival. Erdafitinib is classified as a tyrosine kinase inhibitor, and its main therapeutic indication is for tumors with FGFR gene alterations.

  • Cetrelimab

    Cetrelimab is administered intravenously and is being evaluated in combination with erdafitinib for the treatment of muscle-invasive bladder cancer in patients who are ineligible for cisplatin. It functions as an immune checkpoint inhibitor, targeting the PD-1 pathway to enhance the body's immune response against cancer cells. Cetrelimab is classified as a monoclonal antibody, and its primary therapeutic use is in enhancing the immune system's ability to 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 typically begins in the cells lining the bladder and progresses to invade the muscular wall, making it more aggressive than non-muscle-invasive types. As the disease advances, it can spread to nearby tissues and organs, potentially affecting the lymph nodes and other parts of the body. Symptoms may include blood in the urine, frequent urination, and pain during urination. The progression of the disease can vary, with some cases advancing more rapidly than others. Early detection and monitoring are crucial for managing the disease effectively.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512573-27-01Protocol codeSOGUG2020IEC(VEJ)11Estimated enrolment90 patientsSponsorGrupo Espanol De Oncologia Genitourinaria-Socug

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