Study Comparing Enfortumab Vedotin and Pembrolizumab with Chemotherapy for Patients with Muscle-Invasive Bladder Cancer

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What is this study about?

This clinical trial is focused on studying treatments for muscle-invasive bladder cancer, a type of cancer that affects the bladder muscle. The study will compare two different treatment approaches. One group of participants will receive a combination of two medications: enfortumab vedotin and pembrolizumab (also known by the code name MK-3475). The other group will receive a combination of gemcitabine and cisplatin, which are commonly used chemotherapy drugs. The purpose of the study is to evaluate which treatment is more effective in improving the outcomes for patients with this type of cancer.

Participants in the study will be randomly assigned to one of the two treatment groups. Those in the first group will receive enfortumab vedotin and pembrolizumab, while those in the second group will receive gemcitabine and cisplatin. All treatments will be administered through an intravenous infusion, which means the medication is given directly into a vein. The study will follow participants over a period of time to monitor their health and the progression of their cancer.

The main goal of the study is to compare the event-free survival, which refers to the length of time participants remain free from certain negative events related to their cancer. Additionally, the study will look at other outcomes such as overall survival, which is the length of time participants live after starting the treatment, and the rate of complete response, which means the cancer has disappeared after treatment. Participants’ quality of life will also be assessed throughout the study to understand the impact of the treatments on their daily lives.

1 joining the study

Upon joining the study, you will be assigned to one of two groups. Each group will receive a different treatment plan for muscle-invasive bladder cancer.

2 treatment group assignment

If assigned to Arm A, you will receive a combination of enfortumab vedotin and pembrolizumab. These medications are administered through an intravenous infusion, which means they are given directly into your vein.

If assigned to Arm B, you will receive gemcitabine and cisplatin, also administered through an intravenous infusion.

3 treatment administration

For Arm A, the treatment with enfortumab vedotin and pembrolizumab will be given before and after surgery. The exact schedule and dosage will be explained by your healthcare provider.

For Arm B, the treatment with gemcitabine and cisplatin will be given before surgery. The exact schedule and dosage will be explained by your healthcare provider.

4 surgery

Both groups will undergo a surgical procedure called radical cystectomy (RC) with pelvic lymph node dissection (PLND). This surgery involves the removal of the bladder and nearby lymph nodes.

5 post-surgery treatment

After surgery, if you are in Arm A, you will continue to receive enfortumab vedotin and pembrolizumab as part of your treatment plan.

If you are in Arm B, no further chemotherapy is planned after surgery.

6 follow-up and monitoring

Throughout the study, regular follow-up visits will be scheduled to monitor your health and the effectiveness of the treatment. These visits may include physical exams, imaging tests, and laboratory tests.

Who Can Join the Study?

  • Have a histologically confirmed diagnosis of urothelial carcinoma (UC) / muscle invasive bladder cancer (MIBC) with predominant (50% or more) urothelial histology. This means that a tissue sample from your bladder shows this type of cancer under a microscope.
  • Have clinically non-metastatic bladder cancer, which means the cancer has not spread to other parts of the body. This is determined by imaging tests like a CT scan or MRI of the chest, abdomen, and pelvis.
  • Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND). This means your doctor believes you can undergo surgery to remove the bladder and nearby lymph nodes.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. This is a scale used to assess how well you can perform daily activities. A score of 0 means you are fully active, and a score of 1 means you have some restrictions but can still do light work.
  • Have adequate organ function, meaning your vital organs like the liver and kidneys are working well enough to handle treatment.
  • Be within the age range of adults and older adults.
  • Both male and female participants are eligible.

Who Cannot Join the Study?

  • Patients who do not have Muscle Invasive Bladder Cancer cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are not part of the specified clinical trial groups cannot participate.
  • Patients who are not male or female cannot participate.
  • Patients who are considered part of a vulnerable population cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
KBC Zagreb Zagreb Croatia
Vivantes Netzwerk fuer Gesundheit GmbH Berlin Germany
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet Szolnok Hungary
Radiotherapy Center Cluj S.R.L. Floresti Romania
Complex Oncological Center Plovdiv EOOD Plovdiv Bulgaria
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o. Siedlce Poland
Clinical Research Center Sp. z o.o. Medic-R sp.k. Poznan Poland
Martha-Maria Krankenhaus Halle-Doelau gGmbH Halle (Saale) Germany
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada Manresa Spain
General University Hospital Of Larissa Larissa Greece
University Of Debrecen Debrecen Hungary
Virgen del Rocío University Hospital Sevilla Spain
Centre Hospitalier Universitaire d’Orléans Orléans France
Universitaetsklinikum Regensburg AöR Regensburg Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Ospedale San Raffaele S.r.l. Milan Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Universita’ Degli Studi Di Verona Verona Italy
Alexandra Hospital Athens Greece
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E. Lisbon Portugal
Universita’ Politecnica Delle Marche Ancona Italy
Universidade De Santiago De Compostela Santiago De Compostela Spain
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
General University Hospital Of Patras Patras Greece
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
University Hospital Olomouc Olomouc Czechia
Groupe Hospitalier Diaconesses Croix Saint Simon Paris France
Cardiomed S.R.L. Cluj Napoca Romania
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
KBC Split Split Croatia
Spitalul De Oncologie Monza S.R.L. Bucharest Romania
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Fakultni Thomayerova nemocnice Prague Czechia
University Of Szeged Szeged Hungary
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Aajgzkq Srstsuhmw Lwdepv Nhveuy 2 Necp Pozzuoli Italy
Mgzmsh Histvgbs Hlurp Uexzfyvsldnvgbvnybmd dcw Rlsnrscelgmqhesw Bfzipi Herne Germany
Ckfnpg Hiloxdqfbnk Ej Upjhoraybxwst Dh Lopbckx Limoges France
Agvsgcg Oawsumtqwzq Pbm Lyzvcxlnxvsdqmfdr Cjggipnrrx Catania Italy
Bxdpydsx Uyixvgzkvc Hgyunonj Cmtynb Besançon France
Csieuh Hdnddgpwlv E Ubbqqkaxymyly Dc Cqslxpn Exkuok Coimbra Portugal
Uyncuwwtcrwdifcufshob Mgnoxkvg Aib Munster Germany
Nunkovaq Ibpmarjy Osmojkaqs Ish Mysst Syumhdhkojimwuoxdrgcammhpszt Inhkwima Bmlkjyvw Cracow Poland
Uxyxrdkdlzjktifdnuobw Wasprwynr Alm Wuerzburg Germany
Ivuuipky Cynsjs Dkavvibawmsfqgzxm L'hospitalet De Llobregat Spain
Hjomyvb Prkje Lz Bmqd – Rrfurb Sipej Lille France
Hfgpdxda Vcoz dwaahtxp Barcelona Spain
Wobebmrkrj Stwsoyo Iek Sjgbsae Puk W Pyypaeodx Przemysl Poland

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

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
21.04.2021
Croatia Croatia
Not recruiting
21.04.2021
Czechia Czechia
Not recruiting
21.04.2021
France France
Not recruiting
21.04.2021
Germany Germany
Not recruiting
21.04.2021
Greece Greece
Not recruiting
21.04.2021
Hungary Hungary
Not recruiting
21.04.2021
Italy Italy
Not recruiting
21.04.2021
Poland Poland
Not recruiting
21.04.2021
Portugal Portugal
Not recruiting
21.04.2021
Romania Romania
Not recruiting
21.04.2021
Spain Spain
Not recruiting
21.04.2021

Trial locations

Enfortumab Vedotin is a type of cancer treatment known as an antibody-drug conjugate. It works by attaching to cancer cells and delivering a powerful drug directly to them, which helps to kill the cancer cells while trying to minimize damage to normal cells. In this trial, it is being used to treat muscle-invasive bladder cancer.

Pembrolizumab, also known as MK-3475, is an immunotherapy medication. It helps your immune system to recognize and attack cancer cells more effectively. It is used in this trial to help treat muscle-invasive bladder cancer by boosting the body’s natural defenses against the cancer.

Gemcitabine is a chemotherapy drug that works by interfering with the DNA of cancer cells, preventing them from growing and dividing. It is used in this trial as part of a treatment plan for muscle-invasive bladder cancer, aiming to shrink the tumor before surgery.

Cisplatin is another chemotherapy medication that helps to kill cancer cells by damaging their DNA. It is often used in combination with other drugs to treat various types of cancer, including bladder cancer, as part of a strategy to reduce the size of the tumor before surgical removal.

Muscle Invasive Bladder Cancer – Muscle Invasive Bladder Cancer is a type of bladder cancer that has spread into the muscle layer of the bladder wall. It typically begins in the cells lining the bladder and progresses deeper into the bladder muscle. As the cancer grows, it can invade surrounding tissues and organs, potentially spreading to other parts of the body. The progression of this disease can lead to symptoms such as blood in the urine, frequent urination, and pain during urination. Over time, the cancer may cause more severe symptoms as it affects other areas. The disease’s progression is influenced by various factors, including the cancer’s stage and grade.

Trial ID:
2023-505615-21-00
Protocol code:
MK3475-B15
NCT ID:
NCT04700124
Trial Phase:
Therapeutic confirmatory (Phase III)

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