Study of Enfortumab Vedotin and Pembrolizumab for Patients with Advanced or Metastatic Urothelial Cancer

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What is this study about?

This clinical trial is focused on studying treatments for urothelial cancer, a type of cancer that affects the bladder and other parts of the urinary system. The study is comparing two different treatment approaches. One group of participants will receive a combination of two medications: enfortumab vedotin and pembrolizumab. Pembrolizumab is also known by its code name, MK-3475. The other group will receive standard chemotherapy, which may include medications like gemcitabine, cisplatin, or carboplatin. These treatments are given as solutions through an infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to compare the effectiveness of the combination treatment with the standard chemotherapy in people who have not received prior treatment for their advanced or metastatic urothelial cancer. Participants will be randomly assigned to one of the two treatment groups. The study will monitor the participants over a period of time to see how well the cancer responds to the treatments and to assess overall survival rates.

Throughout the study, participants will receive regular medical check-ups and monitoring to ensure their safety and to track the progress of their treatment. The study aims to provide valuable information on whether the combination of enfortumab vedotin and pembrolizumab offers better outcomes compared to the standard chemotherapy options for patients with this type of cancer.

1 joining the study

Upon joining the study, the patient will be randomly assigned to one of two groups: the experimental group or the control group.

The experimental group will receive a combination of enfortumab vedotin and pembrolizumab, while the control group will receive chemotherapy with either gemcitabine and cisplatin or carboplatin.

2 treatment administration

All medications will be administered as a solution for infusion, which means they will be given through a vein (intravenously).

The specific dosage and frequency of administration will depend on the group to which the patient is assigned.

3 monitoring and assessments

Throughout the study, the patient’s health and response to treatment will be closely monitored.

Regular assessments will be conducted to evaluate the progression of the disease and the patient’s overall health status.

4 completion of treatment

The duration of the treatment will vary depending on the patient’s response and the specific protocol of the study.

After completing the treatment, follow-up assessments will be conducted to monitor the patient’s health and any long-term effects of the treatment.

Who Can Join the Study?

Must have a type of cancer called urothelial carcinoma, which affects areas like the bladder, kidney area, or tubes that carry urine.
Must be 18 years or older.
Must have a measurable disease, meaning the cancer can be measured by doctors using specific guidelines.
Must have a performance status score of 0, 1, or 2, which is a way to measure how well you can perform daily activities. If the score is 2, additional health criteria must be met.
Must provide a sample of the tumor for testing before starting the study. If an old sample is not available, a new one may be needed.
Must have adequate blood and organ function based on specific lab tests.
Women who can have children must agree not to become pregnant during the study and for 6 months after. They must also have a negative pregnancy test before starting the study and use effective birth control.
Women must agree not to breastfeed or donate eggs during the study and for 6 months after.
Men who can father children must agree not to donate sperm during the study and for 6 months after. They must also use effective birth control.
Men with pregnant or breastfeeding partners must use specific precautions to prevent exposure to their partner during the study and for 6 months after.
Must not have received previous treatment for advanced urothelial carcinoma, except in certain cases where treatment was given over 12 months ago.
Must be eligible to receive certain chemotherapy drugs, as determined by the doctor.
Must provide written consent to participate in the study.

Who Cannot Join the Study?

Patients who have a different type of cancer other than urothelial cancer cannot participate. Urothelial cancer is a type of cancer that affects the lining of the urinary system.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not able to follow the study procedures or who have conditions that make it unsafe for them to participate cannot join the study.
Patients who are part of a vulnerable population, meaning they might need special protection or care, may not be eligible to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
University Hospital Jena KöR	Jena	Germany
Hospital Clinico San Carlos	Madrid	Spain
Institut Gustave Roussy	Villejuif	France
Zuyderland Medisch Centrum Stichting	Geleen	The Netherlands
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium
Hospital Universitario De Navarra	Pamplona	Spain
Frisius	Heerenveen	The Netherlands

Other Sites

Site Name	City	Country
Krankenhaus Nordwest GmbH	Frankfurt	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Ospedale San Raffaele S.r.l.	Milan	Italy
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Hospital Clinic De Barcelona	Barcelona	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands
Universitaetsklinikum Mannheim GmbH	Mannheim	Germany
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Aalborg University Hospital	Aalborg	Denmark
Hospital Universitario Lucus Augusti	Lugo	Spain
Lux Med Onkologia Sp. z o.o.	Warsaw	Poland
University Hospital Olomouc	Olomouc	Czechia
Azienda USL Toscana Sud Est	Arezzo	Italy
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Azienda Socio Sanitaria Territoriale Di Cremona	Cremona	Italy
Netherlands Cancer Institute	Amsterdam	The Netherlands
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Centre hospitalier universitaire de Liege	Liege	Belgium
Universita Cattolica Del Sacro Cuore	Rome	Italy
Azienda Ospedaliera S Maria Di Terni	Terni	Italy
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Del Mar	Barcelona	Spain
Az Maria Middelares Gent	Gent	Belgium
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet	Szolnok	Hungary
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada	Manresa	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Universita’ Politecnica Delle Marche	Ancona	Italy
University Of Debrecen	Debrecen	Hungary
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Fakultni Thomayerova nemocnice	Prague	Czechia
Azienda Ospedaliero Universitaria Pisana	Pisa	Italy
Ikzegtxl Rdbyjdagv Puv Ls Scecmx Dww Txoici Dyyq Apljqqt Iuzv Slwtsi	Meldola	Italy
Auovslebw Uhc	Amsterdam	The Netherlands
Cdswot Hdedrwonylt Rukdrcdw Uhmjdurdhzkus Dm Tqvih	Tours	France
Hfjddmej Dt Lb Skxuq Cqyw I Szeb Pns	Barcelona	Spain
Cfufpv Ldjk Bhmrmo	Lyon	France
Ukkobsylkibtoyufrbgun Ezpei Axa	Essen	Germany
Hbjvtczv Uomfflsujplpb Mfxtyfl Ds Vqjmokdbnl	Santander	Spain
Isutpvcm Cufuuz Degpouxjorujvhrin	L'hospitalet De Llobregat	Spain
Csikcvvmi Uodwwdisveufgp Sqmicarfq	Woluwe-Saint-Lambert	Belgium
Uupibijdbpyjibcemrcog Dkwblakpyfh Ayf	Duesseldorf	Germany
Enwatkg Unewpkejxlaj Mayvktd Cnfcltj Rufhftgme (tslmwby Mlt	Rotterdam	The Netherlands
Hvmyuibn Vtph dqlqgqha	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	28.02.2020
Czechia	Not recruiting	28.02.2020
Denmark	Not recruiting	28.02.2020
France	Not recruiting	28.02.2020
Germany	Not recruiting	28.02.2020
Hungary	Not recruiting	28.02.2020
Italy	Not recruiting	28.02.2020
Poland	Not recruiting	28.02.2020
Spain	Not recruiting	28.02.2020
The Netherlands	Not recruiting	28.02.2020

Trial locations

Investigated drugs:

Enfortumab Vedotin is a medication used in the trial to treat urothelial cancer. It is an antibody-drug conjugate, which means it combines an antibody with a drug to target and kill cancer cells more effectively. In this study, it is used in combination with another medication to see if it improves outcomes for patients with advanced cancer.

Pembrolizumab is an immunotherapy drug that helps the body’s immune system fight cancer. It works by blocking a specific protein on cancer cells, allowing the immune system to recognize and attack them. In this trial, it is used alongside enfortumab vedotin to evaluate its effectiveness in treating advanced urothelial cancer.

Gemcitabine is a chemotherapy drug used to treat various types of cancer, including urothelial cancer. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing. In this study, it is part of the control arm to compare its effectiveness against the experimental treatment.

Cisplatin is another chemotherapy medication used in the trial. It works by damaging the DNA in cancer cells, which stops them from multiplying. It is often used in combination with other chemotherapy drugs to treat advanced cancers.

Carboplatin is similar to cisplatin and is used as an alternative chemotherapy option in the trial. It also targets the DNA of cancer cells to prevent their growth. The study compares its effectiveness with the experimental treatment to determine the best approach for treating advanced urothelial cancer.

Urothelial Cancer – Urothelial cancer is a type of cancer that begins in the urothelial cells lining the bladder and other parts of the urinary tract. It is the most common form of bladder cancer. The disease often starts in the bladder’s inner lining and can progress to invade deeper layers of the bladder wall. As it advances, it may spread to nearby tissues and organs, including the lymph nodes and other parts of the body. Symptoms can include blood in the urine, frequent urination, and pain during urination. The progression of the disease can vary, with some cases remaining superficial while others become more invasive.

Trial ID:

2023-503421-19-00

Protocol code:

C5701003

NCT ID:

NCT04223856

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Enfortumab Vedotin and Pembrolizumab for Patients with Advanced or Metastatic Urothelial Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?