Study on the Effectiveness and Safety of Durvalumab with Gemcitabine and Cisplatin for Patients with Muscle-Invasive Bladder Cancer

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What is this study about?

This clinical trial is focused on studying a type of bladder cancer known as muscle-invasive bladder cancer. The study is investigating the effectiveness and safety of a treatment plan that includes a combination of medications. Initially, patients will receive a combination of Durvalumab, Gemcitabine, and Cisplatin as a pre-surgery treatment. After surgery, patients will continue with Durvalumab alone as a follow-up treatment. Durvalumab is a type of medication that helps the immune system fight cancer cells, while Gemcitabine and Cisplatin are chemotherapy drugs that work by stopping the growth of cancer cells.

The purpose of this study is to determine how well this treatment plan works and how safe it is for patients with muscle-invasive bladder cancer. The study will involve several stages, starting with the combination treatment before surgery, followed by surgery, and then continuing with Durvalumab alone. Patients will receive these treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will monitor patients over a period to assess the treatment’s effectiveness and any side effects.

Participants in the study will be closely observed to see how their cancer responds to the treatment and to ensure their safety throughout the process. The study aims to provide valuable information that could improve treatment options for people with muscle-invasive bladder cancer in the future.

1 initial treatment phase

The initial phase involves the administration of a combination of medications to treat muscle-invasive bladder cancer.

The medications used are durvalumab, gemcitabine, and cisplatin. These are administered intravenously, meaning they are given through a vein.

This phase is known as the neoadjuvant treatment phase, which means the treatment is given before the main treatment, such as surgery.

2 surgery

Following the initial treatment phase, a surgical procedure called radical cystectomy is planned.

This surgery involves the removal of the bladder and is a standard treatment for muscle-invasive bladder cancer.

3 post-surgery treatment phase

After surgery, the treatment continues with the administration of durvalumab alone.

This phase is referred to as the adjuvant treatment phase, which means the treatment is given after the main treatment to help prevent cancer from returning.

Durvalumab is administered intravenously during this phase.

4 monitoring and follow-up

Throughout the trial, regular monitoring and follow-up appointments are scheduled to assess the effectiveness and safety of the treatment.

These appointments may include various tests and evaluations to track the progress of the treatment and the patient’s health status.

Who Can Join the Study?

  • Patients must have a type of bladder cancer called muscle-invasive transitional cell carcinoma (TCC), confirmed by a doctor through tests.
  • The cancer should be at a stage where it can be surgically removed, specifically stages T2 to T4a, with no spread to distant parts of the body (N0/1M0).
  • Patients should be planning to have a surgery called radical cystectomy, which involves removing the bladder.
  • Patients must not have received any previous treatments like chemotherapy or immunotherapy for this type of bladder cancer.
  • Patients should have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but can still carry out light work.
  • A sample of the tumor must be available before joining the study.
  • Patients should have a life expectancy of at least 12 weeks when they start the study.
  • Both male and female patients are eligible to participate.
  • Patients must be within the age range of 18 to 64 years old.

Who Cannot Join the Study?

  • Patients who do not have a confirmed diagnosis of muscle-invasive transitional cell carcinoma (TCC) of the bladder. This means that the cancer must be confirmed by examining tissue samples under a microscope.
  • Patients who are not within the specified age range for the study. The study has specific age requirements that participants must meet.
  • Patients who are not able to follow the study procedures or comply with the study requirements. This means that participants must be able to understand and follow the instructions given by the study team.
  • Patients who have other medical conditions that might interfere with the study or make participation unsafe. This means that if a patient has other health issues that could affect the study results or their safety, they may not be able to participate.
  • Patients who are pregnant or breastfeeding. This is because the study may involve treatments that could affect the baby.
  • Patients who are participating in another clinical trial. This is to ensure that the results of the study are not influenced by other treatments or interventions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Centr Georges Francois Leclerc Dijon France
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie Koszalin Poland
University Hospital Jena KöR Jena Germany
Universitaetsmedizin Goettingen Goettingen Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Katholieke Universiteit te Leuven Leuven Belgium
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nimes Nimes France
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centre hospitalier universitaire de Liege Liege Belgium
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Amphia Hospital Breda The Netherlands
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Algemeen Ziekenhuis Delta Roeselare Belgium
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Grand Hopital De Charleroi Charleroi Belgium
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
Centre De Cancerologue Du Grand Montpellier Montpellier France
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie Olsztyn Poland
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku Bialystok Poland
Med Polonia Sp. z o.o. Poznan Poland
Virgen del Rocío University Hospital Sevilla Spain
Universitaetsklinikum Regensburg AöR Regensburg Germany
Universitaetsklinikum Erlangen AöR Erlangen Germany
Ospedale San Raffaele S.r.l. Milan Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Universita’ Degli Studi Di Verona Verona Italy
Universitaetsklinikum Magdeburg AöR Magdeburg Germany
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
University Hospital Olomouc Olomouc Czechia
Netherlands Cancer Institute Amsterdam The Netherlands
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Fakultni Thomayerova nemocnice Prague Czechia
Hvcdypxf Ubjkkmzblzvik Mpzjzaq Dq Vbebimcwze Santander Spain
Dzrraldusxyk Csrxbgo Opkeglnhm Pigfmdoiqygl I Hlkbdbyycvj Wroclaw Poland
Rnttbhhdpm Sxqzxmn Sgguaklpzqhpbvq Ijf Dyk Weqxlrliys Bpyygxfxjrxd Grudziadz Poland
Mmksmsixfk Spiufhd Splsrlvmtypmzpc Izkdietevocv Pqxinrdede W Ondposban Ostroleka Poland
Maqtou Hxcxtqbi Hepyh Upcxwvjwlgqueiypsqnj dic Rheeqihjjeroymki Bpeaeo Herne Germany
Umfabhwhfm Hfwebasp Cawfook Cologne Germany
Evzbtng Udhuvsdlybab Mwcumzv Camkvpd Rkuzlakdt (emumuox Mgy Rotterdam The Netherlands
Uspsuunmzbjjhydycvxae Mggktxfv Adc Munster Germany
Ndjkzwgz Izkhbgfq Oetfkmdvt Ibh Muvbl Sbehgywmtqkugcftnjawrerimseo Iavldaav Bbqujjzp Cracow Poland
Urpzbifejpwkoarpjjlbu Wthyowkyn Ayu Wuerzburg Germany
Alylpic Uxuyq Sttiyywov Lfvpjo Db Bwbdgzp Bologna Italy
Ucvraicwkqydjl Ceiaajp Kniethhgx Gdansk Poland
Cpsiwf Hblrowfenpm Rbrumbqv Dwfkvgbzxtcuct Angers France
Hizltfkl Udvwjbqjhzpjs Hjitoweh Tyffz y Ppwftx Iulneuzo Cbqssm dccfxvfdntfycxkxv (fwvv Badalona Spain
Hysxecif Vzsp dmibjnri Barcelona Spain

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
18.12.2023
Czechia Czechia
Not recruiting
18.12.2023
France France
Not recruiting
18.12.2023
Germany Germany
Not recruiting
18.12.2023
Italy Italy
Not recruiting
18.12.2023
Poland Poland
Not recruiting
18.12.2023
Spain Spain
Not recruiting
18.12.2023
The Netherlands The Netherlands
Not recruiting
18.12.2023

Trial locations

Durvalumab is a medication used in this trial to help the body’s immune system fight cancer. It is given to patients both before and after surgery to see if it can improve outcomes in muscle-invasive bladder cancer.

Gemcitabine is a chemotherapy drug used in this trial to kill cancer cells. It is given in combination with other treatments to enhance its effectiveness against bladder cancer.

Cisplatin is another chemotherapy drug used alongside gemcitabine in this trial. It works by damaging the DNA of cancer cells, which helps to stop their growth and spread.

Investigated diseases:

Muscle-Invasive Bladder Cancer – This disease is characterized by the growth of cancerous cells in the muscle layer of the bladder wall. It begins when transitional cells, which line the bladder, undergo abnormal changes and start to multiply uncontrollably. As the disease progresses, the cancer can invade deeper layers of the bladder and potentially spread to nearby tissues or organs. 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 ID:
2023-510015-19-00
NCT ID:
NCT03732677
Trial Phase:
Therapeutic confirmatory (Phase III)

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