Durvalumab and Chemotherapy in Adults With Muscle-Invasive Bladder Cancer

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hôpital Européen Georges-Pompidou Paris France
Comite Entreprise Paul Papin Angers France
Hospital Clinico San Carlos Madrid Spain
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Azienda Ospedaliero Universitaria Careggi Florence Italy
Centr Georges Francois Leclerc Dijon France

Other Sites

Site Name City Country Status
Centre Antoine Lacassagne Nice France
Centre Hospitalier Universitaire Rouen Rouen France
Capio La Croix Du Sud Quint-Fonsegrives France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Hospital Clinic De Barcelona Barcelona Spain
Universidade De Santiago De Compostela Santiago De Compostela Spain
Hospital Universitario Lucus Augusti Lugo Spain
Netherlands Cancer Institute Amsterdam The Netherlands
Hospital Foch Suresnes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital Del Mar Barcelona Spain
Centre De Cancerologue Du Grand Montpellier Montpellier France
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
MD Anderson Cancer Center Madrid Spain
Societe De Recherche Oncologique Clinique 37 Chambray Les Tours France
Izzimjcx Pebidxzrukmacbb Cyqblc Cqshaq Marseille France
Itsmzynf dp ctyrcfcemopa dl Gxty Nimes France
Htzhjpve Vqxi dibbyaxj Barcelona Spain
Arijqrmwnf Pqetuyjy Hhtwkifw Dl Pnvrx Paris France
Enwypfg Uflotcttunee Mkaapky Cledgoz Raqcdovxf (ehxsjvl Mvh Rotterdam The Netherlands
Htdozgnn Dk Lh Sesat Cmik I Skzo Pkh Barcelona Spain
Cjhnbe Lbyu Bqnsuy Lyon France
Iqsuza Isivuhpf Fkxelcpjajbkd Ofkargwssvl Rome Italy
Isjvdmqv Cumklo Dahjrfppatxczqlxp L'hospitalet De Llobregat Spain
Huqfodkq Usyavybdgofolf Szookhlgmo &acccgr Hxhjuzt da Hfwhjrvbxco STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
09.06.2026
Italy Italy
Not yet recruiting
09.06.2026
Spain Spain
Recruiting
09.06.2026
The Netherlands The Netherlands
Not yet recruiting
09.06.2026

Trial locations

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.

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.

Trial ID:
2024-519246-75-01
Protocol code:
D933RC00002
NCT ID:
NCT06960577
Trial Phase:
Therapeutic exploratory (Phase II)

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