Study of Enfortumab Vedotin and Pembrolizumab for Bladder Preservation in Patients with Muscle‑Invasive Bladder Cancer

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What is this study about?

Muscle-invasive Bladder Cancer is a form of bladder cancer that has grown into the muscle layer of the bladder wall. The study looks at whether a combination of two medicines, enfortumab vedotin given as a solution for infusion and pembrolizumab given as an injection, can treat this condition while allowing the bladder to be kept intact.

The purpose of the study is to find out if the drug combination can lead to a clinical complete response, meaning no detectable cancer after treatment, and to see how many participants remain free of disease for two years. Researchers will also record any side effects and overall safety.

Participants will receive the two medicines together in a series of treatment cycles over several months, with regular doctor visits, scans, and lab tests to check how the cancer is responding and to monitor health. After the treatment period, follow‑up visits will continue for up to two years to observe long‑term outcomes.

1 initial treatment visit

on the first day after joining the study you receive two medicines. enfortumab vedotin is given as a 125 mg infusion (a liquid that is delivered into a vein). pembrolizumab is given as a 400 mg injection (a liquid that is delivered under the skin or into a vein). the exact schedule for repeating these medicines is defined by the study protocol.

the medical team monitors you for any immediate reactions during and after the administration of the medicines.

2 subsequent treatment cycles

you return for additional treatment cycles as instructed by the study schedule. each cycle includes the same doses of enfortumab vedotin (125 mg) and pembrolizumab (400 mg). the interval between cycles is determined by the protocol, but the same medicines and doses are used each time.

3 assessment after four cycles

after completing four cycles of treatment, the investigators evaluate whether a complete clinical response has been achieved. a complete clinical response means that no signs of cancer are found with the tests used in the study.

4 ongoing follow‑up

following the treatment period, you are followed for up to two years. during this time the investigators assess bladder‑preservation event‑free survival, which measures how long the bladder remains cancer‑free without any events related to the disease.

Who Can Join the Study?

You must be 18 years old or older when you sign the informed consent form.
You need to have bladder cancer that has grown into the muscle layer, confirmed by looking at tissue under a microscope, and it must be in one of the specific early‑stage categories (stage cT2‑cT4a, with or without limited spread to nearby lymph nodes).
At least half of the tumor must be made up of urothelial carcinoma, which is the most common type of bladder cancer.
A urologist or cancer doctor must determine that you are a candidate for surgery to remove the bladder (radical cystectomy) and to remove nearby lymph nodes (pelvic lymph node dissection).
You must have a stored sample of your tumor tissue that can be accessed, or you will need a small tissue sample taken (a biopsy) before the study starts.
Your overall health and ability to carry out daily activities must be rated between 0 and 2 on the ECOG performance status scale (0 = fully active, 2 = able to care for yourself but not able to work).
You must have had a tumor removal procedure called transurethral resection of bladder tumor (TURBT) within about two months (60 days, plus up to 14 days) before the screening visit.

Who Cannot Join the Study?

Having existing nerve problems that cause numbness or weakness (known as sensory or motor neuropathy) at a moderate level or worse (Grade ≥ 2) excludes you.
Having cancer that has spread to many lymph nodes (N2 disease) or to other parts of the body (metastatic disease, M1) as seen on imaging excludes you.
Having uncontrolled diabetes within the last three months excludes you. This is defined as a blood sugar control test called HbA1c of 8 % or higher, or an HbA1c between 7 % and < 8 % with symptoms like frequent urination or extreme thirst.
Having a second cancer diagnosed within three years before the study, or still having any leftover disease from a previous cancer, excludes you. (Exceptions are low‑risk non‑melanoma skin cancers, localized prostate cancers treated with cure intent, very low‑risk prostate cancers under watchful waiting, or carcinoma in situ that has been completely removed.)
Having received any previous treatment with drugs that block the immune checkpoints PD‑1, PD‑L1, PD‑L2 or other similar agents that affect T‑cell activity (such as CTLA‑4, OX‑40, CD137) excludes you.
Having received any prior systemic (whole‑body) anti‑cancer therapy for bladder cancer, or any investigational drugs (including enfortumab vedotin or other drugs that use the toxin MMAE attached to an antibody, called ADC) within three years before screening excludes you.
Having had a partial removal of the bladder (partial cystectomy) for bladder cancer excludes you.
Having received any radiation treatment to the bladder (radiotherapy) before the study excludes you.
Having an active eye surface infection or inflammation such as keratitis or an open sore on the eye (corneal ulceration) excludes you, unless it is a mild form called superficial punctate keratitis that is being treated.
Having a past history of non‑infectious lung inflammation (pneumonitis) or interstitial lung disease (ILD) that needed steroid treatment, or currently having pneumonitis/ILD, excludes you.
Having a history of specific lung diseases such as idiopathic pulmonary fibrosis, organizing pneumonia, drug‑induced pneumonitis, idiopathic pneumonitis, or showing active lung inflammation on a screening chest CT scan excludes you.
Having an immune system deficiency (immunodeficiency) or taking strong systemic steroids (more than 10 mg of prednisone or equivalent each day) or other immune‑suppressing medicines within seven days before the first dose excludes you. Inhaled or skin‑applied steroids are allowed if there is no active autoimmune disease, and low‑dose replacement steroids are allowed for adrenal insufficiency.
Having an active autoimmune disease (where the body attacks itself) that required systemic treatment (such as disease‑modifying drugs, steroids, or other immune‑suppressing medicines) in the past two years excludes you.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Jean Perrin	Clermont Ferrand	France
Comite Entreprise Paul Papin	Angers	France
Hospital Clinico San Carlos	Madrid	Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Centre Hospitalier Universitaire De Lille	Lille	France
Institut Gustave Roussy	Villejuif	France
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Oncopole Claudius Regaud	Toulouse	France
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Ospedale San Raffaele S.r.l.	Milan	Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr	Herne	Germany
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
Hospital Foch	Suresnes	France
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
SRH Wald-Klinikum Gera GmbH	Gera	Germany
Hopital Beaujon	Clichy	France
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Complejo Hospitalario Universitario Insular Materno Infantil	Las Palmas De Gran Canaria	Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari	Bari	Italy
Logicuro GmbH	Potsdam	Germany
Cymykd dl Reapvjintythi &tfdudl Ctviyskj Smzycd Awym	STRASBOURG, Alsace	France
Irewehdt Rvdfhczzz Psv Lt Skjlxj Dgq Tszghu Dbpi Avqchum Iowq Sdjjsp	Meldola	Italy
Uyxevyycmjpukdhhutmiz Dspcxohsehg Amk	Duesseldorf	Germany
Ufanbrqbbxsrbaczukbpb Munuitys Aje	Munster	Germany
Aiqyygx Otnixnrgkod Ufjqupvwxiydr Oocaaegp Rhklqrj	Foggia	Italy
Kerdzrmm dxh Uxgfaclhyzrn Mnwerttw Afr	Munich	Germany
Aphgcag Ukukm Smzivvorv Lxblhs Dz Bywrjdf	Bologna	Italy
Ahdpgbe Oefflqxgasp Uxfoeougkjjhp Pfnrw	Parma	Italy
Cgzehf Ltrd Bfmfnz	Lyon	France
Ibjvtz Icxieuei Ftnjbkbypatgw Oedndelmjhe	Rome	Italy
Hkkgunpu Uqfkmzzbsfqfr Dz Lw Pvrfzsrv	Madrid	Spain
Fsdlillia Pcht Lj Iiohcdgnezgwo Bmxnzztef Dcq Hfxsmphj Ulixskwmaxptj Lm Psv	Madrid	Spain
Hnnkfukz Utmrxmjedqmgvm Sdijfrgzpu &mswjmj Hzexzpe dk Hefmpuygpmu	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	31.07.2026
Germany	Not yet recruiting	31.07.2026
Italy	Not yet recruiting	31.07.2026
Spain	Not yet recruiting	31.07.2026

Trial locations

Investigated drugs:

Enfortumab vedotin (brand name Padcev) is a medicine that attaches to a protein found on bladder cancer cells. It carries a chemotherapy drug straight to those cells, helping to kill the cancer while causing less damage to normal cells. In this study the drug is given through an IV infusion and is combined with pembrolizumab to try to shrink or remove the tumor so the bladder can be saved.

Pembrolizumab (brand name Keytruda) is an immunotherapy that helps the body’s immune system see and attack cancer cells. It is given as an injection and works together with enfortumab vedotin to increase the chance that the cancer disappears completely and stays gone.

Muscle-invasive bladder cancer – It is a type of bladder cancer that has grown from the inner lining into the muscle layer of the bladder wall. The disease begins as abnormal cells in the bladder lining and then spreads deeper into the muscle. As it progresses, it can extend to nearby tissues and regional lymph nodes. This growth may cause changes in urinary habits, such as blood in the urine or difficulty urinating. The cancer continues to expand outward if not controlled.

Trial ID:

2025-524488-18-00

Protocol code:

7465-CL-0209

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Enfortumab Vedotin and Pembrolizumab for Bladder Preservation in Patients with Muscle‑Invasive Bladder Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?