Bladder Cancer Clinical Trial

Treatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin or Who Refuse Cisplatin

Summary

A global phase 3, multicenter, randomized, trial, to Determine the Efficacy and Safety of Durvalumab in combination with Tremelimumab and Enfortumab Vedotin or Durvalumab in combination with Enfortumab vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin or who refuse Cisplantin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer.

The goal of the study is to explore the triplet combination of Durvalumab, Tremelimumab and Enfortumab Vedotin in terms of efficacy and safety compared to the current Standard Of Care (SOC).

Volga trial consists of two parts: Safety Run-In and Main Study. In total the study aims to enroll approximately 830 patients, who will receive triplet combination, duplet combination of Durvalumab and Enfortumab vedotin or currently approved SOC in the main trial. In the main part of the trial there is two out of three chances of being on a treatment arm and the treatment is assigned at random by a computer system.

In this trial patients in the two treatment arms will receive either 3 cycles of neoadjuvant Durvalumab + Tremelimumab + Enfortumab Vedotin or Durvalumab + Enfortumab vedotin and after surgery both treatment arms will continue with adjuvant Durvalumab.

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Full Description

Not provided

View Eligibility Criteria

Eligibility Criteria

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 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, as defined by any of the 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.

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

830

Study ID:

NCT04960709

Recruitment Status:

Recruiting

Sponsor:

AstraZeneca

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There are 221 Locations for this study

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Phoenix Arizona, 85054, United States
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Orange California, 92868, United States
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Santa Monica California, 90404, United States
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Colorado Springs Colorado, 80909, United States
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New Haven Connecticut, 06510, United States
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Washington District of Columbia, 20010, United States
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Fort Myers Florida, 33901, United States
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Coeur d'Alene Idaho, 83814, United States
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Maywood Illinois, 60153, United States
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Indianapolis Indiana, 46250, United States
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Brighton Michigan, 48114, United States
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Detroit Michigan, 48202, United States
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Jackson Mississippi, 39213, United States
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Las Vegas Nevada, 89102, United States
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Saddle Brook New Jersey, 07663, United States
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Brooklyn New York, 11219, United States
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Buffalo New York, 14263, United States
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Syracuse New York, 13210, United States
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Cincinnati Ohio, 45219, United States
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Columbus Ohio, 43212, United States
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Portland Oregon, 97239, United States
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Hershey Pennsylvania, 17033, United States
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Fort Worth Texas, 76104, United States
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Houston Texas, 77030, United States
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Irving Texas, 75063, United States
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Norfolk Virginia, 23502, United States
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Tacoma Washington, 98405, United States
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Berazategui , B1884, Argentina
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Buenos Aires , C1120, Argentina
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Caba , C1280, Argentina
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Caba , C1426, Argentina
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Ciudad Autónoma Buenos Aires , C1430, Argentina
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Ciudad de Buenos Aires , C1419, Argentina
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Pergamino , B2700, Argentina
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Pilar , B1629, Argentina
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Rosario , S2000, Argentina
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Graz , 8036, Austria
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Krems , 3500, Austria
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Linz , 4020, Austria
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Salzburg , 5020, Austria
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Wiener Neustadt , 2700, Austria
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Wien , 1020, Austria
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Wien , 1090, Austria
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Wien , 1140, Austria
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Barretos , 14784, Brazil
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Curitiba , 81520, Brazil
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Fortaleza , 60135, Brazil
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Porto Alegre , 90035, Brazil
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Porto Alegre , 90035, Brazil
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Porto Alegre , 90610, Brazil
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Rio de Janeiro , 22250, Brazil
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Santa Maria , 97015, Brazil
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Santo André , 09060, Brazil
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Sao Paulo , 01246, Brazil
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Sao Paulo , 01323, Brazil
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Săo Paulo , 03162, Brazil
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Uberlândia , 38408, Brazil
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Hamilton Ontario, L8V 5, Canada
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Toronto Ontario, M4N 3, Canada
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Toronto Ontario, M5G 2, Canada
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Montreal Quebec, H4A 3, Canada
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Santiago , 75006, Chile
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Santiago , 75009, Chile
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Barranquilla , 80001, Colombia
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Cali , 76004, Colombia
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Medellin , 05001, Colombia
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Medellín , , Colombia
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Amiens , 80090, France
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Bayonne , 64100, France
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Bordeaux Cedex , 33075, France
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Clermont Ferrand , 63011, France
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Lille , 59000, France
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Lyon , 69008, France
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Marseille CEDEX , 13273, France
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Marseille , 13385, France
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Montpellier , 34070, France
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Nice , 06189, France
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Quint-Fonsegrives , 31130, France
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Rennes , 35000, France
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Strasbourg , 67091, France
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Suresnes , 92150, France
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Vandoeuvre les Nancy , 54519, France
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Bielefeld , 33611, Germany
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Bochum , 44791, Germany
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Düsseldorf , 40225, Germany
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Giessen , 35392, Germany
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Hannover , 30559, Germany
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Hannover , 30625, Germany
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Köln , 50937, Germany
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Magdeburg , 39120, Germany
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Mainz , 55131, Germany
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Mannheim , 68167, Germany
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Muenchen , 81377, Germany
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Münster , 48149, Germany
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Regensburg , 93053, Germany
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Reutlingen , 72766, Germany
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Ulm , 89075, Germany
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Athens , 11528, Greece
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Athens , 12462, Greece
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Heraklion , 71110, Greece
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Maroussi, Athens , 15125, Greece
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Shatin , 00000, Hong Kong
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Hadera , 38100, Israel
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Haifa , 31096, Israel
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Holon , 58100, Israel
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Jerusalem , 91120, Israel
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Tel Aviv , 64239, Israel
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Aviano , 33081, Italy
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Bari , 70124, Italy
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Firenze , 50134, Italy
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Meldola , 47014, Italy
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Milano , 20132, Italy
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Milan , 20141, Italy
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Napoli , 80131, Italy
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Padova , 35128, Italy
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Pozzuoli , 80078, Italy
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Reggio Emilia , 42100, Italy
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Roma , 00128, Italy
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Roma , 00137, Italy
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Roma , 00144, Italy
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Terni , 05100, Italy
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Tricase , 73039, Italy
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Verona , 37124, Italy
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Bunkyo-ku , 113-8, Japan
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Fukuoka-shi , 811-1, Japan
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Hamamatsu-shi , 431-3, Japan
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Hirosaki-shi , 036-8, Japan
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Ichikawa-shi , 272-8, Japan
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Kanazawa-shi , 920-8, Japan
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Kashihara-shi , 634-8, Japan
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Kita-gun , 761-0, Japan
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Kobe-shi , 650-0, Japan
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Kumamoto-shi , 860-0, Japan
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Matsuyama-shi , 791-0, Japan
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Miyazaki-shi , 889-1, Japan
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Okayama-shi , 700-8, Japan
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Osaka-shi , 541-8, Japan
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Osaka-shi , 545-8, Japan
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Osakasayama-shi , 589-8, Japan
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Shinjuku-ku , 160-8, Japan
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Toyama-shi , 930-0, Japan
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Tsukuba-shi , 305-8, Japan
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Yokohama-shi , 241-8, Japan
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Busan , 47392, Korea, Republic of
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Goyang-si , 10408, Korea, Republic of
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Incheon , 405-7, Korea, Republic of
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Seodaemun-gu , 03722, Korea, Republic of
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Seongnam-si , 13620, Korea, Republic of
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Seoul , 03080, Korea, Republic of
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Seoul , 06351, Korea, Republic of
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Seoul , 07985, Korea, Republic of
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Colima , 28018, Mexico
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Monterrey , 64000, Mexico
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Monterrey , 64570, Mexico
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Tlalpan , 14050, Mexico
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Arnhem , 6815 , Netherlands
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Breda , 4818 , Netherlands
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Groningen , 9713 , Netherlands
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Hilversum , 1313 , Netherlands
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Hoofddorp , 2134 , Netherlands
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Leiden , 2333 , Netherlands
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Utrecht , 3508 , Netherlands
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Skórzewo , 60-18, Poland
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Warszawa , 02-78, Poland
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Braga , 4710, Portugal
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Coimbra , 3000-, Portugal
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Faro , 8000-, Portugal
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Lisboa , 1350-, Portugal
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Lisboa , 1500-, Portugal
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Lisboa , 1500-, Portugal
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Lisboa , 1649-, Portugal
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Lisbon , 1169-, Portugal
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Porto , 4200-, Portugal
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Vila Nova de Gaia , 4434-, Portugal
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Ekaterinburg , 62010, Russian Federation
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Nizhniy Novgorod , 60307, Russian Federation
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Novosibirsk , 63000, Russian Federation
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Saint Petersburg , 19323, Russian Federation
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St. Petersburg , 19435, Russian Federation
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Ufa , 45005, Russian Federation
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Belgrade , 11000, Serbia
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Belgrad , 11000, Serbia
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Nis , 18000, Serbia
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Sremska Kamenica , 21204, Serbia
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Barcelona , 08035, Spain
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Barcelona , 08036, Spain
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Barcelona , 08041, Spain
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Barcelona , 08208, Spain
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L'Hospitalet de Llobregat , 08907, Spain
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Las Palmas de Gran Canaria , 35016, Spain
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Madrid , 28033, Spain
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Madrid , 28040, Spain
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Madrid , 28046, Spain
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Pamplona , 31008, Spain
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Santander , 39008, Spain
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Sevilla , 41009, Spain
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Taichung , 40447, Taiwan
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Taichung , 40705, Taiwan
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Tainan , 70403, Taiwan
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Tainan , 710, Taiwan
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Taipei , 10048, Taiwan
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Bangkok , 10330, Thailand
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Dusit , 10300, Thailand
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Songkhla , 90110, Thailand
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Adana , 01060, Turkey
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Ankara , 06560, Turkey
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Ankara , 06620, Turkey
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Ankara , 5000, Turkey
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Ankara , , Turkey
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Antalya , , Turkey
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Istanbul , 32098, Turkey
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Istanbul , 34722, Turkey
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Karsiyaka , 35575, Turkey
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Malatya , 44280, Turkey
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Dnipropetrovsk , 49005, Ukraine
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Dnipro , 49102, Ukraine
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Kiev , 3022, Ukraine
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Blackburn , BB2 3, United Kingdom
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Bristol , BS2 8, United Kingdom
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Gillingham , ME7 5, United Kingdom
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Glasgow , G12 0, United Kingdom
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London , EC1A , United Kingdom
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London , NW1 2, United Kingdom
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Sheffield , S10 2, United Kingdom
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Ha Noi , 10000, Vietnam
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Hanoi , 10000, Vietnam
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Ho Chi Minh city , 70000, Vietnam
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Ho Chi Minh , 70000, Vietnam
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Hue , 53000, Vietnam

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

830

Study ID:

NCT04960709

Recruitment Status:

Recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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