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Durvalumab and Chemotherapy in Adults With Muscle-Invasive Bladder Cancer

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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 studying muscle-invasive bladder cancer, a form of bladder cancer that has grown into the muscle layer of the bladder wall. The treatment being studied is durvalumab (IMFINZI), given into a vein, together with cisplatin-based chemotherapy before surgery to remove the bladder, called radical cystectomy. The purpose of the study is to learn how safe this treatment approach is and how well it works in adults with this type of bladder cancer.

In the study, treatment is given before surgery, and then the planned surgery is performed if possible. During the study, there are regular checkups, blood tests, and other routine medical exams to watch for side effects and to see how the disease is responding. After surgery, follow-up continues for a period of time to look for any return of the cancer and to monitor overall health.

Durvalumab is a type of medicine that helps the immune system attack cancer cells. The chemotherapy used with it is ddMVAC, a group of cancer medicines that are commonly given together for bladder cancer. The study is open-label, which means both the medical team and the participant know which treatment is being given.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Start of trial treatment
You begin the study treatment after joining the trial. The treatment includes durvalumab, which is given by intravenous infusion (through a vein), and ddMVAC, which is cisplatin-based chemotherapy.
The study is designed to give durvalumab together with ddMVAC before radical cystectomy (RC), which is surgery to remove the bladder.
Step 2
During neoadjuvant treatment before surgery
You receive durvalumab 1500 mg by intravenous infusion. The product used is IMFINZI 50 mg/mL concentrate for solution for infusion.
You also receive ddMVAC chemotherapy before surgery. The source data do not give the exact dose, frequency, or duration of ddMVAC, but it is given as part of the pre-surgery treatment period.
During this stage, your health is monitored for side effects. The study checks for side effects that are considered possibly related to the study treatment, including serious side effects and changes in laboratory test results.
Step 3
Assessment before surgery
Before radical cystectomy (RC), the study measures whether you have any grade 3 or 4 treatment-related side effects. Grade 3 or 4 means severe or very severe side effects.
The study also checks for side effects that may lead to treatment interruption or stopping treatment.
Step 4
Radical cystectomy
After the pre-surgery treatment period, you undergo radical cystectomy (RC) if surgery is performed.
The study uses tissue from this surgery to assess the response to treatment.
Step 5
After surgery assessment
After RC, the study reviews the surgical tissue to determine whether there is any remaining cancer.
The main tissue-based outcome is whether the result is T0N0M0, which means no sign of tumor in the bladder tissue, no spread to nearby lymph nodes, and no spread to distant sites.
The study also checks whether the result is less than P2, which means the cancer stage in the tissue is below a certain level.
Step 6
Follow-up after treatment and surgery
After treatment and surgery, the study follows your progress over time to look for cancer returning, disease getting worse, or death from any cause.
The study measures event-free survival (EFS), which is the time from the first durvalumab + ddMVAC treatment until the first of these events: cancer returns after RC, disease gets worse if surgery cannot be done for medical reasons, or surgery does not happen when expected or when there is remaining disease.
The study measures disease-free survival (DFS) from the date of RC until the cancer returns after surgery or death from any cause.
The study measures overall survival (OS) from the first durvalumab + ddMVAC treatment until death from any cause.

Who can join the trial?

7 criteria

Have muscle-invasive bladder cancer that can be removed with surgery.
Have a cancer stage of T2 to T4a with N0 or N1, or T1N1. This means the tumor has grown into the bladder muscle and may involve nearby lymph nodes, but has not spread to distant organs.
Have transitional cell histology, which means the cancer cells are of the most common bladder cancer type.
Be planned to have a radical cystectomy at the time of randomization. A radical cystectomy is surgery to remove the bladder.
Have an ECOG performance status of 0 or 1. This means the patient is fully active or only slightly limited in daily activities.
Have a life expectancy of at least 12 weeks when starting the study medicine.
Have not received previous systemic chemotherapy or immunotherapy for this bladder cancer. Systemic chemotherapy means cancer medicine that travels through the whole body. Immunotherapy means treatment that helps the immune system fight cancer.

Who cannot join the trial?

4 criteria

Evidence that the cancer has spread to nearby lymph nodes (small glands that help fight infection), specifically N2-N3 involvement, or has spread to other parts of the body, called metastatic disease, at the time of screening.
Need for immunosuppressive medication for another medical condition. These are medicines that lower the activity of the immune system.
Any contraindication to one of the study drugs. This means a medical reason that makes the drug unsafe or not suitable for the person.
Any active or previously documented autoimmune disorder or inflammatory disorder, except for the allowed exceptions. An autoimmune disorder is a condition where the immune system attacks the body’s own tissues, and an inflammatory disorder is a condition that causes ongoing swelling or irritation in the body.

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Verified sites

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Verified
Assistance Publique Hopitaux De Paris
Paris, France
Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands

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Investigated drugs

Durvalumab is an immunotherapy medicine given through a vein. In this trial, it is used before surgery together with chemotherapy to help the immune system better find and attack bladder cancer cells. The study is looking at how safe it is to give this medicine before surgery in people with muscle-invasive bladder cancer.

Durvalumab

What is already known about the treatment

Durvalumab - Durvalumab is given as a liquid infusion into a vein, usually by a healthcare professional in a clinic or hospital. It is an immune-based cancer medicine that is still widely used and well described in medical literature, especially for several types of cancer, including bladder cancer. It belongs to a group called immune checkpoint inhibitors, and it works by blocking a protein named PD-L1, which helps the immune system recognize and attack cancer cells more easily.

Investigated diseases

Muscle-invasive bladder cancer - A form of bladder cancer in which abnormal cells grow deeply into the bladder wall muscle. It usually develops from earlier, less invasive disease and then becomes more deeply embedded in the bladder tissue. As it progresses, it can spread beyond the bladder wall into nearby tissues or lymph nodes.