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Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC (NIAGARA)

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ClinicalTrials.gov Identifier: NCT03732677
Recruitment Status : Recruiting
First Posted : November 6, 2018
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment and Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer

Condition or disease Intervention/treatment Phase
Muscle Invasive Bladder Cancer Drug: Durvalumab Drug: Cisplatin Drug: Gemcitabine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1050 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Open-Label, Multi-Center, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Gemcitabine+Cisplatin for Neoadjuvant Treatment Followed by Durvalumab Alone for Adjuvant Treatment in Patients With Muscle-Invasive Bladder Cancer
Actual Study Start Date : November 16, 2018
Estimated Primary Completion Date : December 18, 2025
Estimated Study Completion Date : December 18, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: Arm 1
Chemotherapy + Durvalumab
Drug: Durvalumab
Anti- PD-L1 Antibody

Drug: Cisplatin
Chemotherapy Agent

Drug: Gemcitabine
Chemotherapy agent

Active Comparator: Arm 2
Chemotherapy alone
Drug: Cisplatin
Chemotherapy Agent

Drug: Gemcitabine
Chemotherapy agent




Primary Outcome Measures :
  1. Pathologic complete response (pCR) rates at time of cystectomy following neoadjuvant treatment, as assessed by central pathology review [ Time Frame: Up to 6 months ]
  2. Event-free survival (EFS) per central review defined as time from randomization to the first recurrence of disease (after cystectomy), or progression in patients who were precluded for cystectomy, or death due to any cause, whichever occurs first [ Time Frame: Up to 48 months ]

Secondary Outcome Measures :
  1. Proportion of patients who achieve <P2 (Pa,P1 and Cis) at time of cystectomy following neoadjuvant treatment, as assessed by central pathology review [ Time Frame: Up to 6 months ]
  2. EFS at 24 months (EFS24) defined as time from randomization to the first recurrence of disease (after cystectomy), or first progression in patients who were precluded for cystectomy, or death due to any cause, whichever occurs first [ Time Frame: Up to 24 months ]
  3. Proportion of patients who undergo cystectomy [ Time Frame: Up to 6 months ]
  4. Overall survival rate at 5 years, as determined based on time from date of randomization to date of death, from any cause [ Time Frame: Up to 60 months ]
  5. PFS2 defined as the time from the date of randomization to the earliest date of progression which occurs on subsequent therapy following an EFS event or death [ Time Frame: Up to 84 months ]
  6. Safety and Tolerability as evaluated by adverse events occurring throughout the study [ Time Frame: Up to 84 months ]
  7. Immunogenicity of durvalumab when used in combination with gemcitabine/cisplatin as measured by presence of antidrug antibodies (ADA) [ Time Frame: Up to 12 months ]


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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • Patient resectable muscle-invasive bladder cancer with clinical stage T2N0M0-T4aN0M0 with transitional cell histology
  • Patients must be planning to undergo a radical cystectomy at the time of randomization
  • 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 or metastatic 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03732677


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

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Locations
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United States, Alabama
Research Site Recruiting
Birmingham, Alabama, United States, 35294
United States, California
Research Site Withdrawn
Fountain Valley, California, United States, 92708
Research Site Withdrawn
Fullerton, California, United States, 92835
Research Site Recruiting
Los Angeles, California, United States, 90095
Research Site Withdrawn
Monterey, California, United States, 93940
Research Site Withdrawn
Salinas, California, United States, 93901
Research Site Withdrawn
Santa Rosa, California, United States, 95403
Research Site Recruiting
Stanford, California, United States, 94305-5824
United States, Colorado
Research Site Withdrawn
Denver, Colorado, United States, 80211
United States, Connecticut
Research Site Recruiting
New Haven, Connecticut, United States, 06520
United States, Florida
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Tampa, Florida, United States, 33612
United States, Illinois
Research Site Not yet recruiting
Chicago, Illinois, United States, 60611
United States, Iowa
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Iowa City, Iowa, United States, 52242
United States, Kansas
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Westwood, Kansas, United States, 66205
United States, Kentucky
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Louisville, Kentucky, United States, 40202
United States, Louisiana
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New Orleans, Louisiana, United States, 70112
Research Site Withdrawn
New Orleans, Louisiana, United States, 70121
United States, Maryland
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Baltimore, Maryland, United States, 21204
United States, Michigan
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Ann Arbor, Michigan, United States, 48109
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Detroit, Michigan, United States, 48201
United States, New Jersey
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Neptune, New Jersey, United States, 07754
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New Brunswick, New Jersey, United States, 08903
United States, New York
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New York, New York, United States, 10029
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Rochester, New York, United States, 14642
United States, North Carolina
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Durham, North Carolina, United States, 27710
United States, Ohio
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Columbus, Ohio, United States, 43210
United States, Pennsylvania
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Bethlehem, Pennsylvania, United States, 18015
United States, Rhode Island
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Providence, Rhode Island, United States, 02903
United States, Vermont
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Burlington, Vermont, United States, 05401
United States, Wisconsin
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Milwaukee, Wisconsin, United States, 53226
Australia
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Box Hill, Australia, 3128
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Elizabeth Vale, Australia, 5112
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Herston, Australia, 4029
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Macquarie University, Australia, 2109
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Murdoch, Australia, 6150
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Prahran, Australia, 3004
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South Brisbane, Australia, 4101
Belgium
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Brugge, Belgium, 8000
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Charleroi, Belgium, 6000
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Kortrijk, Belgium, 8500
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Leuven, Belgium, 3000
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Liège, Belgium, 4000
Brazil
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Barretos, Brazil, 14784-400
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Passo Fundo, Brazil, 99010-080
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Porto Alegre, Brazil, 90020-090
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Porto Alegre, Brazil, 90470-340
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Porto Alegre, Brazil, 90610-000
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Porto Alegre, Brazil, 91350-200
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Rio de Janeiro, Brazil, 20231-050
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Sao Paulo, Brazil, 01323-903
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Sao Paulo, Brazil, 01509-900
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Sao Paulo, Brazil, 04101-000
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São José do Rio Preto, Brazil, 15090-000
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São Paulo, Brazil, 01246-000
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São Paulo, Brazil, 03102-002
Canada, Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
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Hamilton, Ontario, Canada, L8V 5C2
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London, Ontario, Canada, N6A 5W9
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Ottawa, Ontario, Canada, K1H 8L6
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Toronto, Ontario, Canada, M5G IX6
Canada, Quebec
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Montreal, Quebec, Canada, H2X 0C2
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Sherbrooke, Quebec, Canada, J1H 5N4
Chile
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Antofagasta, Chile, 1267348
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Puerto Montt, Chile, 5480000
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Santiago de Chile, Chile, 6770128
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Santiago, Chile, 7520349
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Temuco, Chile, 4810218
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Viña del Mar, Chile, 2540488
Czechia
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Brno, Czechia, 656 53
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Hradec Kralove, Czechia, 500 05
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Olomouc, Czechia, 779 00
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Praha 5, Czechia, 150 06
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Praha, Czechia, 180 81
France
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Angers Cedex 01, France, 49033
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Dijon, France, 21079
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Grenoble Cedex 09, France, 38043
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Montpellier, France, 34070
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Nimes, France, 30029
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Pierre Benite, France, 69495
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Poitiers Cedex, France, 86021
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Rouen, France, F-76031 CE
Germany
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Bonn, Germany, 53127
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Köln, Germany, 50937
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Magdeburg, Germany, 39120
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Nürnberg, Germany, 90491
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Ulm, Germany, 89081
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Würzburg, Germany, 97080
Israel
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Haifa, Israel, 31096
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Jerusalem, Israel, 91120
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Kfar Saba, Israel, 95847
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Petach-Tikva, Israel, 4941492
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Ramat Gan, Israel, 52621
Italy
Research Site Not yet recruiting
Bari, Italy, 70124
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Bologna, Italy, 40138
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Firenze, Italy, 50134
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Milano, Italy, 20133
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Napoli, Italy, 80131
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Orbassano, Italy, 10043
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Verona, Italy, 37134
Japan
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Bunkyo-ku, Japan, 113-8603
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Fukuoka-shi, Japan, 811-1347
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Fukuoka, Japan, 812-8582
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Hirosaki-shi, Japan, 036-8563
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Hiroshima-shi, Japan, 730-8518
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Kanazawa-shi, Japan, 920-8641
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Koto-ku, Japan, 135-8550
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Kumamoto-shi, Japan, 860-0008
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Miyazaki-city, Japan, 889-1692
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Nagasaki-shi, Japan, 852-8501
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Nagoya-shi, Japan, 466-8560
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Niigata-shi, Japan, 951-8520
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Osaka-shi, Japan, 541-8567
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Osaka-shi, Japan, 545-8586
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Osakasayama-shi, Japan, 589-8511
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Sendai-shi, Japan, 980-0872
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Shinjuku-ku, Japan, 160-8582
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Toyama-shi, Japan, 930-0194
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Tsukuba-shi, Japan, 305-8576
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Yokohama-shi, Japan, 232-0024
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Yokohama-shi, Japan, 241-8515
Korea, Republic of
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Daegu, Korea, Republic of, 41404
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Goyang-si, Korea, Republic of, 10408
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Incheon, Korea, Republic of, 21565
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Seongnam, Korea, Republic of, 13620
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Seoul, Korea, Republic of, 03080
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Seoul, Korea, Republic of, 136-705
Netherlands
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Amsterdam, Netherlands, 1066 CX
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Amsterdam, Netherlands, 1081 HV
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Breda, Netherlands, 4819 EV
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Rotterdam, Netherlands, 3015 GD
Philippines
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Baguio City, Philippines, 2600
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Cebu, Philippines, 6000
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Davao City, Philippines, 8000
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Makati, Philippines, 1229
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Manila, Philippines, 1015
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Quezon City, Philippines, 1101
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Quezon City, Philippines, 1104
Poland
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Bialystok, Poland, 15-027
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Gdańsk, Poland, 80-214
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Grudziądz, Poland, 86-300
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Koszalin, Poland, 75-581
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Olsztyn, Poland, 10-228
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Poznan, Poland, 60-693
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Radom, Poland, 26-600
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Warszawa, Poland, 02-781
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Wroclaw, Poland, 53-413
Russian Federation
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Ivanovo, Russian Federation, 153040
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Krasnoyarsk, Russian Federation, 660133
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Moscow, Russian Federation, 105077
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Nizhniy Novgorod, Russian Federation, 603074
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Omsk, Russian Federation, 644013
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Samara, Russian Federation, 443031
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St. Petersburg, Russian Federation, 194017
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St. Petersburg, Russian Federation, 194354
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Vologda, Russian Federation, 160012
Spain
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Badalona, Spain, 08916
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Barcelona, Spain, 08035
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Córdoba, Spain, 14004
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Las Palmas de Gran Canaria, Spain, 35016
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Madrid, Spain, 28007
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Madrid, Spain, 28041
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Santander, Spain, 39008
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Sevilla, Spain, 41013
Taiwan
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Kaohsiung, Taiwan, 807
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Taichung, Taiwan, 404
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Taichung, Taiwan, 40705
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Tainan, Taiwan, 704
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Tainan, Taiwan, 710
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Taipei City, Taiwan, 10050
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Taipei, Taiwan, 11217
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Taoyuan City, Taiwan, 333
Turkey
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Ankara, Turkey, 06590
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Edirne, Turkey, 22030
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Istanbul, Turkey, 34030
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Izmir, Turkey
United Kingdom
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Edinburgh, United Kingdom, EH4 2XR
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Guildford, United Kingdom, GU2 7WG
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London, United Kingdom, EC1A 7BE
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Nottingham, United Kingdom, NG5 1PB
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Sheffield, United Kingdom, S10 2SJ
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Wirral, United Kingdom, CH63 4JY
Vietnam
Research Site Recruiting
Hanoi, Vietnam, 100000
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Ho Chi Minh city, Vietnam, 700000
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Ho Chi Minh, Vietnam, 700000
Research Site Not yet recruiting
Hochiminh, Vietnam, 700000
Sponsors and Collaborators
AstraZeneca

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03732677     History of Changes
Other Study ID Numbers: D933RC00001
2018-001811-59 ( EudraCT Number )
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by AstraZeneca:
Bladder Cancer
Immunotherapy
PD-L1
Durvalumab (MEDI4736)
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Gemcitabine
Cisplatin
Durvalumab
Antibodies, Monoclonal
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological