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Study on Durvalumab with Trimodality Therapy for Patients with Muscle-Invasive 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 bladder cancer known as muscle-invasive bladder cancer. The trial is investigating the use of a treatment called Durvalumab, which is also known by its code name MEDI4736. Durvalumab is a medication that is given as a solution through an infusion, which means it is administered directly into the bloodstream. The purpose of the study is to determine if adding Durvalumab after standard treatment can improve the time patients remain free from cancer.

Participants in the study will have already completed a standard treatment approach called trimodality therapy, which includes surgery, chemotherapy, and radiation therapy. After this initial treatment, participants will be randomly assigned to receive either Durvalumab or no additional treatment, which is referred to as surveillance. The study will monitor participants over time to see if Durvalumab helps in preventing the return of cancer or the development of new cancer.

The study aims to assess the effectiveness of Durvalumab in improving outcomes for patients with muscle-invasive bladder cancer. It will also look at other factors such as the control of cancer in the bladder area, overall survival rates, and the impact on quality of life. The trial is expected to continue until early 2026, with participants being closely followed throughout the study period.

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

    Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of muscle-invasive bladder cancer and completion of prior trimodality therapy, which includes surgery, chemotherapy, and radiation.

    A CT scan of the chest, abdomen, and pelvis is required within 8 weeks of enrollment to ensure no evidence of metastatic disease.

    Consent is obtained, and a pregnancy test is conducted for women of childbearing potential.

  2. Step 2

    Treatment initiation

    Treatment begins within 2 working days after enrollment. The treatment involves the administration of durvalumab, a medication given as a solution for infusion.

    The medication is provided as a concentrate for solution for infusion, known as IMFINZI 50 mg/mL.

  3. Step 3

    Treatment administration

    The durvalumab infusion is administered according to the study protocol. The frequency and duration of administration are determined by the study guidelines and the patient's response to treatment.

  4. Step 4

    Monitoring and follow-up

    Regular follow-up appointments are scheduled to monitor the patient's health and response to the treatment.

    Assessments include evaluating disease-free survival, locoregional control rate, and overall survival.

    Quality of life and adverse events are also evaluated during these follow-up visits.

  5. Step 5

    Completion of study

    The study is estimated to conclude by January 31, 2026. Upon completion, final assessments are conducted to evaluate the outcomes of the treatment.

Who can join the trial?

17 criteria

  • Must have a confirmed diagnosis of **urothelial carcinoma** of the bladder. This includes patients with mixed types of cancer cells, but not those with only small cell carcinoma.
  • Must provide a sample from the primary tumor for further analysis.
  • Must have completed previous treatment involving surgery, chemotherapy, and radiation therapy before joining the study. The study treatment should start within 42 days after finishing these treatments.
  • Must be able to complete quality of life questionnaires in English, French, or Spanish.
  • Must give consent according to local and regulatory requirements.
  • Must be available for treatment and follow-up at the participating center.
  • Study treatment should start within 2 working days after joining the study.
  • Women and men who can have children must agree to use a highly effective birth control method during and for 3 months after treatment. Women will have a pregnancy test before the study to confirm eligibility.
  • Can have another cancer if it does not affect the safety or effectiveness of the study treatment.
  • Must have been diagnosed with cancer at stage T2-T4a N0M0, which means the cancer has invaded the muscle but has not spread to lymph nodes or other parts of the body.
  • Must have a CT scan of the chest, abdomen, and pelvis within 8 weeks before joining the study, showing no signs of cancer spread.
  • Must be 18 years of age or older.
  • Must have a life expectancy of more than 6 months.
  • Must have an **ECOG performance status** of 0-2, which is a scale to assess how the disease affects daily living abilities, and must weigh more than 30 kg.
  • Must have enough healthy blood cells, which is referred to as having adequate **hematologic reserve**.
  • Must have a kidney function test showing a **creatinine clearance** of at least 30 ml/min, which measures how well the kidneys are working.
  • Must have adequate liver function.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer that is not **muscle-invasive bladder cancer**.
  • Patients who have not received **standard trimodality therapy**, which is a combination of treatments including surgery, chemotherapy, and radiation.
  • Patients who are not in the age range specified for the study.
  • Patients who are not able to follow the study procedures or attend the required visits.
  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have had an allergic reaction to similar medications in the past.
  • Patients who have a history of certain immune system disorders.
  • Patients who have received certain medications or treatments that might affect the study results.
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Investigated drugs

Durvalumab (MEDI4736) is an immunotherapy medication used in this trial. It is designed to help the body's immune system recognize and attack cancer cells. In this study, it is given to patients after they have received standard treatment for muscle-invasive bladder cancer to see if it can improve the time patients remain free from cancer.

What is already known about the treatment

Durvalumab – Durvalumab is administered as an intravenous infusion, typically given in a hospital or clinical setting. It is currently being studied in clinical trials for its effectiveness in treating muscle-invasive bladder cancer. The main therapeutic indication for durvalumab is to improve disease-free survival in patients with this type of cancer. At the molecular level, durvalumab works by blocking a protein called PD-L1, which helps the immune system recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor, a type of immunotherapy that enhances the body's natural defenses 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. The progression of muscle-invasive bladder cancer can lead to symptoms such as blood in the urine, frequent urination, and pelvic pain. Early stages may not show significant symptoms, but as the cancer grows, these symptoms become more pronounced. The disease requires careful monitoring and management to prevent further spread and complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512502-26-00Protocol codeBL.13Estimated enrolment131 patientsSponsorFundacion Cris De Investigacion Para Vencer El Cancer

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