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New combo therapy shows promise in bladder cancer fight

NCT ID NCT03528694

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 08, 2026 · Updated 2 times

Summary

This study tests whether adding the immunotherapy drug durvalumab to standard BCG treatment helps keep high-risk bladder cancer from coming back. About 1,000 adults with non-muscle-invasive bladder cancer who have not had BCG before will receive either the combination or BCG alone. The main goal is to see if the combination extends the time patients remain cancer-free.

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

1,018 people

The number who actually took part.

Started

May 2018

Expected to finish

Oct 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: For inclusion in the study, patients should fulfill the following criteria: * Aged at least 18 years * BCG-naïve (patients who have not received prior intravesical BCG or who previously received but stopped BCG more than 3 years before study entry are eligible) * Local histological confirmation (based on pathology report) of high-risk transitional cell carcinoma of the urothelium of the urinary bladder confined to the mucosa or submucosa. A high risk tumor is defined as one of the following * T1 tumor * High grade/ G3 tumor * CIS * Multiple and recurrent and large (with diameter of largest tumor ≥3 cm) tumors (all conditions must be met in this point) * Complete resection of all Ta/T1 papillary disease prior to randomization, with the TURBT removing high-risk NMIBC performed not more than 4 months before randomization in the study. Patients with residual CIS after TURBT are eligible * No prior radiotherapy for bladder cancer * No prior exposure to immune-mediated therapy of cancer including, but not limited to, other anti CTLA-4, anti-PD-1, anti-PD-L1, and anti-programmed cell death ligand 2 antibodies. Patients who have been treated with anticancer vaccines will be excluded Exclusion Criteria: Patients should not enter the study if any of the following exclusion criteria are fulfilled: * Evidence of muscle-invasive, locally advanced, metastatic, and/or extra vesical bladder cancer (ie, T2, T3, T4, and / or stage IV) * Concurrent extravesical (ie, urethra, ureter, or renal pelvis), non-muscle-invasive transitional cell carcinoma of the urothelium * Previous investigational product (IP) assignment in the present study * Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for noncancer related conditions (eg, hormone replacement therapy) is acceptable. Chemotherapy for previous instances of NMIBC is acceptable. * Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). The following are exceptions to this criterion: * Patients with vitiligo or alopecia * Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement * Any chronic skin condition that does not require systemic therapy * Patients without active disease in the last 5 years may be included but only after consultation with the Study Physician * Patients with celiac disease controlled by diet alone * History of another primary malignancy except for * Malignancy treated with curative intent and with no known active disease ≥ 2 years before the first dose of IP and of low potential risk for recurrence during the study period * Adequately treated nonmelanoma skin cancer or lentigo maligna withoutevidence of disease * Adequately treated CIS without evidence of disease * Prostate cancer (tumor/node/metastasis stage) of stage ≤ T2cN0M0 without biochemical recurrence or progression that in the opinion of the Investigator does not require active intervention * Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. 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, computed tomography \[CT\] scan premedication)

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Conditions

The condition(s) this trial relates to.

non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms superficial urinary bladder carcinoma

As listed by the trial registrant

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

Non-muscle invasive bladder cancer

Contacts and locations

Locations

  • Research Site

    Auchenflower, 4066, Australia

  • Research Site

    Box Hill, 3128, Australia

  • Research Site

    Brisbane, 4122, Australia

  • Research Site

    Kogarah, 2217, Australia

  • Research Site

    Orange, 2800, Australia

  • Research Site

    Parkville, 3000, Australia

  • Research Site

    Westmead, 2145, Australia

  • Research Site

    Wollongong, 2500, Australia

  • Research Site

    Graz, 8036, Austria

  • Research Site

    Innsbruck, 6020, Austria

  • Research Site

    Linz, 4020, Austria

  • Research Site

    Salzburg, 5020, Austria

  • Research Site

    Vienna, 1090, Austria

  • Research Site

    Brussels, 1070, Belgium

  • Research Site

    Ghent, 9000, Belgium

  • Research Site

    Leuven, 3000, Belgium

  • Research Site

    Roeselare, 8800, Belgium

  • Research Site

    Kingston, Ontario, K7L 3J7, Canada

  • Research Site

    Toronto, Ontario, M5G 2M9, Canada

  • Research Site

    Chicoutimi, Quebec, G7H 5H6, Canada

  • Research Site

    Montreal, Quebec, H2X 3E4, Canada

  • Research Site

    Québec, Quebec, G1J 1Z4, Canada

  • Research Site

    Amiens, 80054, France

  • Research Site

    Angers, 49033, France

  • Research Site

    Bordeaux, 33076, France

  • Research Site

    Lyon, 69437, France

  • Research Site

    Marseille, 13003, France

  • Research Site

    Montpellier, 34295, France

  • Research Site

    Strasbourg, 67098, France

  • Research Site

    Suresnes, 92151, France

  • Research Site

    Berlin, 10117, Germany

  • Research Site

    Cologne, 50968, Germany

  • Research Site

    Duisburg, 47169, Germany

  • Research Site

    Hanover, 30625, Germany

  • Research Site

    Heidelberg, 69120, Germany

  • Research Site

    Marburg, 35043, Germany

  • Research Site

    Mettmann, 40822, Germany

  • Research Site

    Mühlheim An Der Ruhr, 45468, Germany

  • Research Site

    München, 81377, Germany

  • Research Site

    Münster, 48149, Germany

  • Research Site

    Nürtingen, 72622, Germany

  • Research Site

    Wesel, 46483, Germany

  • Research Site

    Würselen, 52146, Germany

  • Research Site

    Zirndorf, 90513, Germany

  • Research Site

    Bunkyō City, 113-8603, Japan

  • Research Site

    Fukuoka, 812-8582, Japan

  • Research Site

    Hirosaki-shi, 036-8563, Japan

  • Research Site

    Kanazawa, 920-8641, Japan

  • Research Site

    Kita-gun, 761-0793, Japan

  • Research Site

    Koshigaya-shi, 343-8555, Japan

  • Research Site

    Kōtoku, 135-8550, Japan

  • Research Site

    Matsuyama, 791-0280, Japan

  • Research Site

    Miyazaki, 889-1692, Japan

  • Research Site

    Nagasaki, 852-8501, Japan

  • Research Site

    Nagoya, 467-0001, 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

    Sapporo, 060-8543, Japan

  • Research Site

    Shinjuku-ku, 160-8582, Japan

  • Research Site

    Toyama, 930-0194, Japan

  • Research Site

    Tsukuba, 305-8576, Japan

  • Research Site

    Yokohama, 232-0024, Japan

  • Research Site

    Amsterdam, 1081 HV, Netherlands

  • Research Site

    Breda, 4818 CK, Netherlands

  • Research Site

    Utrecht, 3543 AZ, Netherlands

  • Research Site

    Bialystok, 15-950, Poland

  • Research Site

    Gdansk, 80-952, Poland

  • Research Site

    Grudziądz, 86-300, Poland

  • Research Site

    Koszalin, 75-581, Poland

  • Research Site

    Piotrkow Trybunalski, 97-300, Poland

  • Research Site

    Poznan, 61-731, Poland

  • Research Site

    Warsaw, 02-005, Poland

  • Research Site

    Warsaw, 02-781, Poland

  • Research Site

    Wroclaw, 50-556, Poland

  • Research Site

    Wroclaw, 53-413, Poland

  • Research Site

    Ivanovo, 153040, Russia

  • Research Site

    Krasnoyarsk, 660133, Russia

  • Research Site

    Moscow, 105077, Russia

  • Research Site

    Moscow, 115280, Russia

  • Research Site

    Moscow, 125367, Russia

  • Research Site

    Nizhny Novgorod, 603074, Russia

  • Research Site

    Obninsk, 249036, Russia

  • Research Site

    Omsk, 644013, Russia

  • Research Site

    Saint Petersburg, 191014, Russia

  • Research Site

    Saint Petersburg, 194017, Russia

  • Research Site

    Saint Petersburg, 194044, Russia

  • Research Site

    Saint Petersburg, 194354, Russia

  • Research Site

    Saint Petersburg, 195271, Russia

  • Research Site

    Saint Petersburg, 197758, Russia

  • Research Site

    Vologda, 160012, Russia

  • Research Site

    Yaroslavl, 150054, Russia

  • Research Site

    Badajoz, 06008, Spain

  • Research Site

    Barcelona, 08025, Spain

  • Research Site

    Barcelona, 08036, Spain

  • Research Site

    Barcelona, 08208, Spain

  • Research Site

    Barcelona, 8003, Spain

  • Research Site

    Elche(Alicante), 03202, Spain

  • Research Site

    Madrid, 08035, Spain

  • Research Site

    Madrid, 28040, Spain

  • Research Site

    Madrid, 28041, Spain

  • Research Site

    Madrid, 28046, Spain

  • Research Site

    Málaga, 29010, Spain

  • Research Site

    Oviedo, 33011, Spain

  • Research Site

    Pamplona, 31008, Spain

  • Research Site

    Pozuelo de Alarcón, 28223, Spain

  • Research Site

    Seville, 41009, Spain

  • Research Site

    Seville, 41014, Spain

  • Research Site

    Valencia, 46014, Spain

  • Research Site

    Valencia, 46026, Spain

  • Research Site

    Birmingham, B15 2TH, United Kingdom

  • Research Site

    Glasgow, G12 0YN, United Kingdom

  • Research Site

    Guildford, CU2 7XX, United Kingdom

  • Research Site

    London, E1 1BB, United Kingdom

  • Research Site

    London, NW1 2PG, United Kingdom

  • Research Site

    London, SE1 9RT, United Kingdom

  • Research Site

    Sheffield, S10 2JF, United Kingdom

  • Research Site

    Southampton, S016 6YD, United Kingdom

  • Research Site

    Taunton, TA1 5DA, United Kingdom

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