Assessment of Efficacy and Safety of Durvalumab Plus BCG Compared to the Standard Therapy With BCG in Non-muscle Invasive Bladder Cancer
NCT ID: NCT03528694
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1018 participants
INTERVENTIONAL
2018-05-14
2028-10-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Durvalumab plus BCG (induction + maintenance)
Durvalumab (MEDI4736) plus Bacillus Calmette-Guerrin (BCG) combination therapy
Durvalumab (MEDI4736)
Investigational product
Bacillus Calmette-Guerin (BCG)
Standard of care
Durvalumab plus BCG (induction only)
Durvalumab (MEDI4736) plus Bacillus Calmette-Guerrin (BCG) combination therapy
Durvalumab (MEDI4736)
Investigational product
Bacillus Calmette-Guerin (BCG)
Standard of care
BCG treatment (Standard of care therapy)
Bacillus Calmette-Guerrin (BCG) standard of care treatment
Bacillus Calmette-Guerin (BCG)
Standard of care
Interventions
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Durvalumab (MEDI4736)
Investigational product
Bacillus Calmette-Guerin (BCG)
Standard of care
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Auchenflower, , Australia
Research Site
Box Hill, , Australia
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Brisbane, , Australia
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Kogarah, , Australia
Research Site
Orange, , Australia
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Parkville, , Australia
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Westmead, , Australia
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Wollongong, , Australia
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Graz, , Austria
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Innsbruck, , Austria
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Linz, , Austria
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Salzburg, , Austria
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Vienna, , Austria
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Brussels, , Belgium
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Ghent, , Belgium
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Leuven, , Belgium
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Roeselare, , Belgium
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Kingston, Ontario, Canada
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Toronto, Ontario, Canada
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Chicoutimi, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Amiens, , France
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Angers, , France
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Bordeaux, , France
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Lyon, , France
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Marseille, , France
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Montpellier, , France
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Strasbourg, , France
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Suresnes, , France
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Berlin, , Germany
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Cologne, , Germany
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Duisburg, , Germany
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Hanover, , Germany
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Heidelberg, , Germany
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Marburg, , Germany
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Mettmann, , Germany
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Mühlheim An Der Ruhr, , Germany
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München, , Germany
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Münster, , Germany
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Nürtingen, , Germany
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Wesel, , Germany
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Würselen, , Germany
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Zirndorf, , Germany
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Bunkyō City, , Japan
Research Site
Fukuoka, , Japan
Research Site
Hirosaki-shi, , Japan
Research Site
Kanazawa, , Japan
Research Site
Kita-gun, , Japan
Research Site
Koshigaya-shi, , Japan
Research Site
Kōtoku, , Japan
Research Site
Matsuyama, , Japan
Research Site
Miyazaki, , Japan
Research Site
Nagasaki, , Japan
Research Site
Nagoya, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Osakasayama-shi, , Japan
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Sapporo, , Japan
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Shinjuku-ku, , Japan
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Toyama, , Japan
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Tsukuba, , Japan
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Yokohama, , Japan
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Amsterdam, , Netherlands
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Breda, , Netherlands
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Utrecht, , Netherlands
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Bialystok, , Poland
Research Site
Gdansk, , Poland
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Grudziądz, , Poland
Research Site
Koszalin, , Poland
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Piotrkow Trybunalski, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Wroclaw, , Poland
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Ivanovo, , Russia
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Krasnoyarsk, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Obninsk, , Russia
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Omsk, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Vologda, , Russia
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Yaroslavl, , Russia
Research Site
Badajoz, , Spain
Research Site
Barcelona, , Spain
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Barcelona, , Spain
Research Site
Barcelona, , Spain
Research Site
Barcelona, , Spain
Research Site
Elche(Alicante), , Spain
Research Site
Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
Research Site
Madrid, , Spain
Research Site
Málaga, , Spain
Research Site
Oviedo, , Spain
Research Site
Pamplona, , Spain
Research Site
Pozuelo de Alarcón, , Spain
Research Site
Seville, , Spain
Research Site
Seville, , Spain
Research Site
Valencia, , Spain
Research Site
Valencia, , Spain
Research Site
Birmingham, , United Kingdom
Research Site
Glasgow, , United Kingdom
Research Site
Guildford, , United Kingdom
Research Site
London, , United Kingdom
Research Site
London, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Sheffield, , United Kingdom
Research Site
Southampton, , United Kingdom
Research Site
Taunton, , United Kingdom
Countries
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References
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De Santis M, Palou Redorta J, Nishiyama H, Krawczynski M, Seyitkuliev A, Novikov A, Guerrero-Ramos F, Zukov R, Kato M, Kawahara T, Goeman L, Puente J, Hellmis E, Powles T, Radziszewski P, Gust KM, Vasey P, Bigot P, Fradet Y, Hunting J, Armstrong J, Boulos S, Hois S, Shore ND; POTOMAC Investigators. Durvalumab in combination with BCG for BCG-naive, high-risk, non-muscle-invasive bladder cancer (POTOMAC): final analysis of a randomised, open-label, phase 3 trial. Lancet. 2025 Nov 8;406(10516):2221-2234. doi: 10.1016/S0140-6736(25)01897-5. Epub 2025 Oct 17.
Other Identifiers
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2017-002979-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D419JC00001
Identifier Type: -
Identifier Source: org_study_id
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