Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New hope for bladder cancer patients who Can't take standard chemo

NCT ID NCT04960709

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests whether combining two immunotherapy drugs (durvalumab and tremelimumab) with a targeted therapy (enfortumab vedotin) works better than current standard care for people with muscle-invasive bladder cancer who cannot take or refuse cisplatin chemotherapy. About 712 participants will receive the drug combinations before and after bladder removal surgery. The study aims to see if these combinations improve event-free survival and are safe.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

712 people

The number who actually took part.

Started

Aug 2021

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 130 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically or cytologically documented muscle-invasive UC of the bladder. * Participants with transitional cell and mixed transitional/non-transitional cell histologies; * Participants with MIBC clinical tumor (T) stage T2-T4aN0/1M0 or UC of the bladder with clinical state T1N1M0 (participants with T1 stage are allowed only with N1 disease) * Participants should also have not received prior systemic chemotherapy or immunotherapy for the treatment of MIBC or bladder UC. * Medically fit for cystectomy and able to receive neoadjuvant therapy; * Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC; * ECOG performance status of 0,1,2 at enrollment. * Availability of tumor sample prior to study entry; * Must have a life expectancy of at least 12 weeks at randomization. * Cisplatin-ineligible, following criteria based on Galsky et al 2011 OR Refuse cisplatin based chemotherapy (must be documented in the medical records) Exclusion criteria: * Evidence of lymph node (N2+) or metastatic TCC/UC disease at the time of screening. * Active infection * Uncontrolled intercurrent illness * Prior exposure to immune-mediated therapy (with exclusion of Bacillus-Calmette Guerin \[BCG\]), including but not limited to other anti-CTLA-4, anti--PD-1, anti PD-L1, or anti-PD-L2 antibodies. * Current or prior use of immunosuppressive medication within 14 days before the first dose of IPs.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Muscle invasive bladder cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

infiltrating bladder urothelial carcinoma Urinary Bladder Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Muscle invasive bladder cancer

Contacts and locations

Locations

  • Research Site

    Orange, California, 92868, United States

  • Research Site

    Santa Monica, California, 90404, United States

  • Research Site

    New Haven, Connecticut, 06510, United States

  • Research Site

    Washington D.C., District of Columbia, 20010, United States

  • Research Site

    Fort Myers, Florida, 33901, United States

  • Research Site

    Coeur d'Alene, Idaho, 83814, United States

  • Research Site

    Maywood, Illinois, 60153, United States

  • Research Site

    Indianapolis, Indiana, 46250, United States

  • Research Site

    Iowa City, Iowa, 52242, United States

  • Research Site

    Louisville, Kentucky, 40207, United States

  • Research Site

    Scarborough, Maine, 04074, United States

  • Research Site

    Boston, Massachusetts, 02111, United States

  • Research Site

    Brighton, Michigan, 48114, United States

  • Research Site

    Jackson, Mississippi, 39213, United States

  • Research Site

    Las Vegas, Nevada, 89102, United States

  • Research Site

    Saddle Brook, New Jersey, 07663, United States

  • Research Site

    Brooklyn, New York, 11219, United States

  • Research Site

    Buffalo, New York, 14263, United States

  • Research Site

    New York, New York, 10040, United States

  • Research Site

    Syracuse, New York, 13210, United States

  • Research Site

    Portland, Oregon, 97239, United States

  • Research Site

    Hershey, Pennsylvania, 17033, United States

  • Research Site

    Pittsburgh, Pennsylvania, 15212, United States

  • Research Site

    Knoxville, Tennessee, 37932, United States

  • Research Site

    Austin, Texas, 78731, United States

  • Research Site

    Dallas, Texas, 75246, United States

  • Research Site

    Fort Worth, Texas, 76104, United States

  • Research Site

    Houston, Texas, 77030, United States

  • Research Site

    Irving, Texas, 75063, United States

  • Research Site

    Norfolk, Virginia, 23502, United States

  • Research Site

    Spokane, Washington, 99208, United States

  • Research Site

    Buenos Aires, C1431FWO, Argentina

  • Research Site

    CABA, C1426ANZ, Argentina

  • Research Site

    Ciudad de Buenos Aires, C1280AEB, Argentina

  • Research Site

    Ciudad de Buenos Aires, C1419AHL, Argentina

  • Research Site

    Pergamino, B2700CPM, Argentina

  • Research Site

    Graz, 8036, Austria

  • Research Site

    Krems, 3500, Austria

  • Research Site

    Linz, 4020, Austria

  • Research Site

    Vienna, 1020, Austria

  • Research Site

    Wiener Neustadt, 2700, Austria

  • Research Site

    Barretos, 14784-400, Brazil

  • Research Site

    Curitiba, 81520-060, Brazil

  • Research Site

    Fortaleza, 60135-237, Brazil

  • Research Site

    Porto Alegre, 90035-001, Brazil

  • Research Site

    Porto Alegre, 90035-003, Brazil

  • Research Site

    Rio de Janeiro, 22250-905, Brazil

  • Research Site

    Santa Maria, 97015-450, Brazil

  • Research Site

    São Paulo, 01246-000, Brazil

  • Research Site

    São Paulo, 01323-903, Brazil

  • Research Site

    Săo Paulo, 03162-065, Brazil

  • Research Site

    Uberlândia, 38408-150, Brazil

  • Research Site

    Abbotsford British Columbia, British Columbia, V2S 3N5, Canada

  • Research Site

    Toronto, Ontario, M4N 3M5, Canada

  • Research Site

    Québec, Quebec, G1R 2J6, Canada

  • Research Site

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Research Site

    Santiago, 7500653, Chile

  • Research Site

    Santiago, 7500921, Chile

  • Research Site

    Amiens, 80090, France

  • Research Site

    Bayonne, 64100, France

  • Research Site

    Clermont-Ferrand, 63011, France

  • Research Site

    Lille, 59000, France

  • Research Site

    Lyon, 69008, France

  • Research Site

    Marseille, 13273, France

  • Research Site

    Marseille, 13385, France

  • Research Site

    Montpellier, 34070, France

  • Research Site

    Nice, 06189, France

  • Research Site

    Pierre-Bénite, 69495, France

  • Research Site

    Quint-Fonsegrives, 31130, France

  • Research Site

    Saint-Priez En Jarez, 42270, France

  • Research Site

    Strasbourg, 67091, France

  • Research Site

    Suresnes, 92151, France

  • Research Site

    Vandœuvre-lès-Nancy, 54519, France

  • Research Site

    Bielefeld, 33611, Germany

  • Research Site

    Bochum, 44791, Germany

  • Research Site

    Cologne, 50937, Germany

  • Research Site

    Düsseldorf, 40225, Germany

  • Research Site

    Giessen, 35392, Germany

  • Research Site

    Hanover, 30625, Germany

  • Research Site

    Herne, 44625, Germany

  • Research Site

    Magdeburg, 39120, Germany

  • Research Site

    Mainz, 55131, Germany

  • Research Site

    Mannheim, 68167, Germany

  • Research Site

    München, 81377, Germany

  • Research Site

    Münster, 48149, Germany

  • Research Site

    Regensburg, 93053, Germany

  • Research Site

    Reutlingen, 72766, Germany

  • Research Site

    Ulm, 89075, Germany

  • Research Site

    Athens, 11528, Greece

  • Research Site

    Athens, 12462, Greece

  • Research Site

    Maroussi, Athens, 15125, Greece

  • Research Site

    Shatin, 00000, Hong Kong

  • Research Site

    Hadera, 38100, Israel

  • Research Site

    Haifa, 31096, Israel

  • Research Site

    Jerusalem, 9103102, Israel

  • Research Site

    Jerusalem, 9112001, Israel

  • Research Site

    Tel Aviv, 64239, Israel

  • Research Site

    Bari, 70124, Italy

  • Research Site

    Florence, 50134, Italy

  • Research Site

    Meldola, 47014, Italy

  • Research Site

    Milan, 20132, Italy

  • Research Site

    Milan, 20141, Italy

  • Research Site

    Padova, 35128, Italy

  • Research Site

    Pozzuoli, 80078, Italy

  • Research Site

    Reggio Emilia, 42100, Italy

  • Research Site

    Roma, 00128, Italy

  • Research Site

    Roma, 00137, Italy

  • Research Site

    Roma, 00144, Italy

  • Research Site

    Terni, 05100, Italy

  • Research Site

    Tricase, 73039, Italy

  • Research Site

    Verona, 37124, Italy

  • Research Site

    Bunkyō City, 113-8431, Japan

  • Research Site

    Fukuoka, 811-1395, Japan

  • Research Site

    Hamamatsu, 431-3192, Japan

  • Research Site

    Ichikawa-shi, 272-8516, Japan

  • Research Site

    Kanazawa, 920-8641, Japan

  • Research Site

    Kashihara-shi, 634-8522, Japan

  • Research Site

    Kawasaki-shi, 216-8511, Japan

  • Research Site

    Kita-gun, 761-0793, Japan

  • Research Site

    Kobe, 650-0017, Japan

  • Research Site

    Kumamoto, 860-0008, Japan

  • Research Site

    Matsuyama, 791-0288, Japan

  • Research Site

    Miyazaki, 889-1692, Japan

  • Research Site

    Niigata, 951-8566, Japan

  • Research Site

    Okayama, 700-8558, Japan

  • Research Site

    Osaka, 541-8567, Japan

  • Research Site

    Osaka, 545-8586, Japan

  • Research Site

    Osakasayama-shi, 589-8511, Japan

  • Research Site

    Toyama, 930-0194, Japan

  • Research Site

    Tsukuba, 305-8576, Japan

  • Research Site

    Yokohama, 241-8515, Japan

  • Research Site

    Colima, 28018, Mexico

  • Research Site

    Monterrey, 64000, Mexico

  • Research Site

    Arnhem, 6815 AD, Netherlands

  • Research Site

    Breda, 4818 CK, Netherlands

  • Research Site

    Groningen, 9713 GZ, Netherlands

  • Research Site

    Hoofddorp, 2134 TM, Netherlands

  • Research Site

    Leiden, 2333 ZA, Netherlands

  • Research Site

    Utrecht, 3508 GA, Netherlands

  • Research Site

    Gdansk, 80-214, Poland

  • Research Site

    Nowa Sól, 67-106, Poland

  • Research Site

    Skórzewo, 60-185, Poland

  • Research Site

    Warsaw, 02-781, Poland

  • Research Site

    Braga, 4710, Portugal

  • Research Site

    Coimbra, 3000-075, Portugal

  • Research Site

    Faro, 8000-386, Portugal

  • Research Site

    Lisbon, 1169-050, Portugal

  • Research Site

    Lisbon, 1350-352, Portugal

  • Research Site

    Lisbon, 1500-458, Portugal

  • Research Site

    Lisbon, 1500-650, Portugal

  • Research Site

    Lisbon, 1649-035, Portugal

  • Research Site

    Belgrade, 11000, Serbia

  • Research Site

    Kamenitz, 21204, Serbia

  • Research Site

    Busan, 47392, South Korea

  • Research Site

    Goyang-si, 10408, South Korea

  • Research Site

    Incheon, 405-760, South Korea

  • Research Site

    Seongnam-si, 13620, South Korea

  • Research Site

    Seoul, 02841, South Korea

  • Research Site

    Seoul, 03080, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    Seoul, 06591, South Korea

  • Research Site

    Seoul, 07985, South Korea

  • Research Site

    Barcelona, 08035, Spain

  • Research Site

    Barcelona, 08036, Spain

  • Research Site

    Barcelona, 08041, Spain

  • Research Site

    Barcelona, 08208, Spain

  • Research Site

    L'Hospitalet de Llobregat, 08907, Spain

  • Research Site

    Las Palmas de Gran Canaria, 35016, Spain

  • Research Site

    Madrid, 28033, Spain

  • Research Site

    Madrid, 28040, Spain

  • Research Site

    Madrid, 28046, Spain

  • Research Site

    Pamplona, 31008, Spain

  • Research Site

    Seville, 41009, Spain

  • Research Site

    Taichung, 40447, Taiwan

  • Research Site

    Taichung, 40705, Taiwan

  • Research Site

    Tainan, 70403, Taiwan

  • Research Site

    Tainan, 710, Taiwan

  • Research Site

    Bangkok, 10330, Thailand

  • Research Site

    Dusit, 10300, Thailand

  • Research Site

    Songkhla, 90110, Thailand

  • Research Site

    Adana, 01060, Turkey (Türkiye)

  • Research Site

    Ankara, 06560, Turkey (Türkiye)

  • Research Site

    Ankara, 06620, Turkey (Türkiye)

  • Research Site

    Ankara, 5000, Turkey (Türkiye)

  • Research Site

    Ankara, Turkey (Türkiye)

  • Research Site

    Antalya, 07025, Turkey (Türkiye)

  • Research Site

    Cordaleo, 35575, Turkey (Türkiye)

  • Research Site

    Edirne, 22030, Turkey (Türkiye)

  • Research Site

    Istanbul, 32098, Turkey (Türkiye)

  • Research Site

    Istanbul, 34722, Turkey (Türkiye)

  • Research Site

    London, EC1A 7BE, United Kingdom

  • Research Site

    London, NW1 2PG, United Kingdom

  • Research Site

    Hanoi, 100000, Vietnam

  • Research Site

    Hà Nội, 100000, Vietnam

  • Research Site

    Ho Chi Minh City, 700000, Vietnam

  • Research Site

    Huế, 530000, Vietnam

More trials for these conditions

Other studies related to the condition(s) this trial covers.