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Bladder cancer drug combo shows promise in major trial

NCT ID NCT03732677

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Updated 1 time

Summary

This study tests whether adding the immunotherapy drug durvalumab to standard chemotherapy before and after bladder removal surgery helps people with muscle-invasive bladder cancer. About 1,063 participants will receive either the drug combo or standard care. The goal is to see if the cancer disappears completely after treatment and if it delays the cancer from coming back.

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

1,063 people

The number who actually took part.

Started

Nov 2018

Expected to finish

Nov 2027

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: * Patient resectable muscle-invasive bladder cancer with clinical stage T2-T4aN0/1M0 with transitional and mixed transitional cell histology * Patients must be planning to undergo a radical cystectomy * Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC * ECOG performance status of 0 or 1 * Must have a life expectancy of at least 12 weeks at randomization Exclusion: * Evidence of lymph node (N2-N3) or metastatic (M1) disease at time of screening. * Prior pelvic radiotherapy treatment within 2 years of randomization to study * 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 investigational product (IP). The following are exceptions to this criterion: Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular injection); Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent; Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication) * Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. * Uncontrolled intercurrent illness * Active infection including Tuberculosis, Hepatitis B, Hepatitis C, and Human Immunodeficiency

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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

    Birmingham, Alabama, 35294, United States

  • Research Site

    Los Angeles, California, 90095, United States

  • Research Site

    Palo Alto, California, 94304, United States

  • Research Site

    New Haven, Connecticut, 06520, United States

  • Research Site

    Chicago, Illinois, 60611, United States

  • Research Site

    Geneva, Illinois, 60134, United States

  • Research Site

    Iowa City, Iowa, 52242, United States

  • Research Site

    Westwood, Kansas, 66205, United States

  • Research Site

    Louisville, Kentucky, 40202, United States

  • Research Site

    New Orleans, Louisiana, 70112, United States

  • Research Site

    Towson, Maryland, 21204, United States

  • Research Site

    Ann Arbor, Michigan, 48109, United States

  • Research Site

    Detroit, Michigan, 48201, United States

  • Research Site

    New York, New York, 10029, United States

  • Research Site

    Rochester, New York, 14642, United States

  • Research Site

    Bethlehem, Pennsylvania, 18015, United States

  • Research Site

    Burlington, Vermont, 05401, United States

  • Research Site

    Milwaukee, Wisconsin, 53226, United States

  • Research Site

    Brisbane, 4122, Australia

  • Research Site

    Elizabeth Vale, 5112, Australia

  • Research Site

    Macquarie University, 2109, Australia

  • Research Site

    Melbourne, 3004, Australia

  • Research Site

    Murdoch, 6150, Australia

  • Research Site

    South Brisbane, 4101, Australia

  • Research Site

    Bruges, 8000, Belgium

  • Research Site

    Charleroi, 6000, Belgium

  • Research Site

    Kortrijk, 8500, Belgium

  • Research Site

    Leuven, 3000, Belgium

  • Research Site

    Liège, 4000, Belgium

  • Research Site

    Roeselare, 8800, Belgium

  • Research Site

    Barretos, 14784-400, Brazil

  • Research Site

    Porto Alegre, 90020-090, Brazil

  • Research Site

    Porto Alegre, 90470-340, Brazil

  • Research Site

    Porto Alegre, 90610-000, Brazil

  • Research Site

    Porto Alegre, 91350-200, Brazil

  • Research Site

    Rio de Janeiro, 20231-050, Brazil

  • Research Site

    Santa Maria, 97015-450, Brazil

  • Research Site

    São José do Rio Preto, 15090-000, Brazil

  • Research Site

    São Paulo, 01246-000, Brazil

  • Research Site

    São Paulo, 01323-903, Brazil

  • Research Site

    São Paulo, 01509-900, Brazil

  • Research Site

    São Paulo, 03102-002, Brazil

  • Research Site

    Edmonton, Alberta, T6G 1Z2, Canada

  • Research Site

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Research Site

    London, Ontario, N6A 5W9, Canada

  • Research Site

    Ottawa, Ontario, K1H 8L6, Canada

  • Research Site

    Toronto, Ontario, M5G IX6, Canada

  • Research Site

    Montreal, Quebec, H2X 0C2, Canada

  • Research Site

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Research Site

    Antofagasta, 1267348, Chile

  • Research Site

    Port Montt, 5480000, Chile

  • Research Site

    Santiago, 7520349, Chile

  • Research Site

    Temuco, 4810218, Chile

  • Research Site

    Temuco, 4810469, Chile

  • Research Site

    Viña del Mar, 2540488, Chile

  • Research Site

    Brno, 656 53, Czechia

  • Research Site

    Brno, 656 91, Czechia

  • Research Site

    Hradec Králové, 500 05, Czechia

  • Research Site

    Olomouc, 77900, Czechia

  • Research Site

    Prague, 128 08, Czechia

  • Research Site

    Prague, 140 59, Czechia

  • Research Site

    Prague, 180 81, Czechia

  • Research Site

    Angers, 49033, France

  • Research Site

    Dijon, 21079, France

  • Research Site

    Grenoble, 38043, France

  • Research Site

    Montpellier, 34070, France

  • Research Site

    Nîmes, 30029, France

  • Research Site

    Pierre-Bénite, 69495, France

  • Research Site

    Poitiers, 86021, France

  • Research Site

    Rouen, F-76031 CE, France

  • Research Site

    Bergisch Gladbach, 51465, Germany

  • Research Site

    Bonn, 53127, Germany

  • Research Site

    Cologne, 50937, Germany

  • Research Site

    Erlangen, 91054, Germany

  • Research Site

    Göttingen, 37075, Germany

  • Research Site

    Herne, 44625, Germany

  • Research Site

    Jena, 07747, Germany

  • Research Site

    Magdeburg, 39120, Germany

  • Research Site

    Mannheim, 68167, Germany

  • Research Site

    Münster, 48149, Germany

  • Research Site

    Nuremberg, 90491, Germany

  • Research Site

    Oldenburg, 23758, Germany

  • Research Site

    Regensburg, 93053, Germany

  • Research Site

    Ulm, 89081, Germany

  • Research Site

    Würzburg, 97080, Germany

  • Research Site

    Haifa, 31096, Israel

  • Research Site

    Jerusalem, 91120, Israel

  • Research Site

    Kfar Saba, 95847, Israel

  • Research Site

    Petah Tikva, 4941492, Israel

  • Research Site

    Ramat Gan, 52621, Israel

  • Research Site

    Bari, 70124, Italy

  • Research Site

    Bologna, 40138, Italy

  • Research Site

    Florence, 50134, Italy

  • Research Site

    Milan, 20132, Italy

  • Research Site

    Milan, 20133, Italy

  • Research Site

    Naples, 80131, Italy

  • Research Site

    Orbassano, 10043, Italy

  • Research Site

    Pozzuoli, 80078, Italy

  • Research Site

    Verona, 37126, Italy

  • Research Site

    Bunkyō City, 113-8603, Japan

  • Research Site

    Fukuoka, 811-1347, Japan

  • Research Site

    Fukuoka, 812-8582, Japan

  • Research Site

    Hirosaki-shi, 036-8563, Japan

  • Research Site

    Hiroshima, 730-8518, Japan

  • Research Site

    Kanazawa, 920-8641, Japan

  • Research Site

    Kōtoku, 135-8550, Japan

  • Research Site

    Kumamoto, 860-0008, Japan

  • Research Site

    Miyazaki, 889-1692, Japan

  • Research Site

    Nagasaki, 852-8501, Japan

  • Research Site

    Nagoya, 466-8560, Japan

  • Research Site

    Niigata, 951-8520, Japan

  • Research Site

    Osaka, 541-8567, Japan

  • Research Site

    Osaka, 545-8586, Japan

  • Research Site

    Osakasayama-shi, 589-8511, Japan

  • Research Site

    Sendai, 980-0872, Japan

  • Research Site

    Toyama, 930-0194, Japan

  • Research Site

    Tsukuba, 305-8576, Japan

  • Research Site

    Yokohama, 232-0024, Japan

  • Research Site

    Yokohama, 241-8515, Japan

  • Research Site

    Amsterdam, 1066 CX, Netherlands

  • Research Site

    Amsterdam, 1081 HV, Netherlands

  • Research Site

    Breda, 4818 CK, Netherlands

  • Research Site

    Rotterdam, 3015 GD, Netherlands

  • Research Site

    Baguio City, 2600, Philippines

  • Research Site

    Cebu, 6000, Philippines

  • Research Site

    Davao City, 8000, Philippines

  • Research Site

    Makati, 1229, Philippines

  • Research Site

    Manila, 1015, Philippines

  • Research Site

    Quezon City, 1101, Philippines

  • Research Site

    Quezon City, 1104, Philippines

  • Research Site

    Bialystok, 15-027, Poland

  • Research Site

    Gdansk, 80-952, Poland

  • Research Site

    Grudziądz, 86-300, Poland

  • Research Site

    Koszalin, 75-581, Poland

  • Research Site

    Krakow, 30-510, Poland

  • Research Site

    Olsztyn, 10-228, Poland

  • Research Site

    Ostrołęka, 07-410, Poland

  • Research Site

    Poznan, 60-693, Poland

  • Research Site

    Warsaw, 02-781, Poland

  • Research Site

    Wroclaw, 53-413, Poland

  • Research Site

    Krasnoyarsk, 660133, Russia

  • Research Site

    Moscow, 105077, Russia

  • Research Site

    Nizhny Novgorod, 603074, Russia

  • Research Site

    Novosibirsk, 630007, Russia

  • Research Site

    Saint Petersburg, 194017, Russia

  • Research Site

    Saint Petersburg, 194044, Russia

  • Research Site

    Saint Petersburg, 194354, Russia

  • Research Site

    Saint Petersburg, 197022, Russia

  • Research Site

    Samara, 443031, Russia

  • Research Site

    Ufa, 450000, Russia

  • Research Site

    Vologda, 160012, Russia

  • Research Site

    Daegu, 41404, South Korea

  • Research Site

    Goyang-si, 10408, South Korea

  • Research Site

    Gyeonggi-do, 13620, South Korea

  • Research Site

    Incheon, 21565, South Korea

  • Research Site

    Seoul, 03080, South Korea

  • Research Site

    Seoul, 05505, South Korea

  • Research Site

    Seoul, 136-705, South Korea

  • Research Site

    Badalona, 08916, Spain

  • Research Site

    Barcelona, 08035, Spain

  • Research Site

    Córdoba, 14004, Spain

  • Research Site

    Las Palmas de Gran Canaria, 35016, Spain

  • Research Site

    Madrid, 28007, Spain

  • Research Site

    Madrid, 28041, Spain

  • Research Site

    Santander, 39008, Spain

  • Research Site

    Seville, 41013, Spain

  • Research Site

    Kaohsiung City, 807, Taiwan

  • Research Site

    Taichung, 404, Taiwan

  • Research Site

    Taichung, 40705, Taiwan

  • Research Site

    Tainan, 704, Taiwan

  • Research Site

    Tainan, 710, Taiwan

  • Research Site

    Taipei, 10050, Taiwan

  • Research Site

    Taipei, 11217, Taiwan

  • Research Site

    Taoyuan City, 333, Taiwan

  • Research Site

    Ankara, 06590, Turkey (Türkiye)

  • Research Site

    Cordaleo, 35575, Turkey (Türkiye)

  • Research Site

    Edirne, 22030, Turkey (Türkiye)

  • Research Site

    Istanbul, 34030, Turkey (Türkiye)

  • Research Site

    Istanbul, 34457, Turkey (Türkiye)

  • Research Site

    Izmir, Turkey (Türkiye)

  • Research Site

    Edinburgh, EH4 2XR, United Kingdom

  • Research Site

    London, E1 1BB, United Kingdom

  • Research Site

    Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

  • Research Site

    Nottingham, NG5 1PB, United Kingdom

  • Research Site

    Sheffield, S10 2SJ, United Kingdom

  • Research Site

    Hanoi, 100000, Vietnam

  • Research Site

    Ho Chi Minh City, 700000, Vietnam

  • Research Site

    Hochiminh, 70000, Vietnam

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