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Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer

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ClinicalTrials.gov Identifier: NCT02516241
Recruitment Status : Recruiting
First Posted : August 5, 2015
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 (Durvalumab) Monotherapy and MEDI4736 (Durvalumab) in Combination with Tremelimumab Versus Standard of Care Chemotherapy in Patients with Stage IV Urothelial Cancer

Condition or disease Intervention/treatment Phase
Urothelial Cancer Drug: MEDI4736 (Durvalumab) Drug: Tremelimumab Drug: Cisplatin Drug: Carboplatin Drug: Gemcitabine Phase 3

Detailed Description:
This is a randomized, open-label, controlled, multi-center, global Phase III study to determine the efficacy and safety of MEDI4736 (Durvalumab) monotherapy and MEDI4736 (Durvalumab) in combination with tremelimumab versus SoC (cisplatin + gemcitabine or carboplatin + gemcitabine doublet) first-line chemotherapy in treatment-naïve patients with histologically or cytologically documented, unresectable, Stage IV transitional cell carcinoma (transitional cell and mixed transitional/non-transitional cell histologies) of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra) and to allow sufficient flexibility for Investigators and patients to select the agents that reflect their normal clinical practice and national guidelines. The patients enrolled in the study will be randomized 1:1:1 to receive treatment with combination therapy, monotherapy, or SoC (cisplatin + gemcitabine or carboplatin + gemcitabine, based on cisplatin eligibility). Patients will be treated with MEDI4736 (Durvalumab) or MEDI4736 (Durvalumab) with tremelimumab, or treated with SoC until progressive disease (PD) is confirmed, unacceptable toxicity occurs, withdrawal of consent, or another discontinuation criterion is met. Patients will be followed for up to 2 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 (Durvalumab) Monotherapy and MEDI4736 (Durvalumab) in Combination With Tremelimumab Versus Standard of Care Chemotherapy in Patients With Unresectable Stage IV Urothelial Cancer
Actual Study Start Date : November 2, 2015
Estimated Primary Completion Date : September 23, 2019
Estimated Study Completion Date : September 23, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arm Intervention/treatment
Experimental: Combination Therapy
MEDI4736 (Durvalumab) + Tremelimumab
Drug: MEDI4736 (Durvalumab)
IV infusion

Drug: Tremelimumab
IV infusion

Experimental: Monotherapy
MEDI4736 (Durvalumab)
Drug: MEDI4736 (Durvalumab)
IV infusion

Active Comparator: Standard of Care
Standard of Care Chemotherapy Treatment
Drug: Cisplatin
IV infusion

Drug: Carboplatin
IV infusion

Drug: Gemcitabine
IV infusion




Primary Outcome Measures :
  1. To assess the efficacy of MEDI4736 + tremelimumab combination therapy versus SoC in terms of OS in patients with unresectable Stage IV UC [ Time Frame: Up to 4 years ]
  2. To assess the efficacy of MEDI4736 monotherapy versus SoC in terms of OS in patients with unresectable Stage IV PD-L1- High UC [ Time Frame: up to 4 years ]

Secondary Outcome Measures :
  1. To assess the efficacy of MEDI4736 monotherapy compared to SoC in terms of PFS in patients with PD-L1-High UC [ Time Frame: 4 years ]
  2. To assess the efficacy of MEDI4736 + tremelimumab combination therapy versus SoC in terms of PFS in patients with UC [ Time Frame: 4 years ]
  3. To further assess the efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of ORR [ Time Frame: 4 years ]
  4. To further assess the efficacy of MEDI4736 monotherapy compared to SoC in terms of ORR [ Time Frame: 4 years ]
  5. To assess disease-related symptoms and HRQoL in UC patients treated with MEDI4736 monotherapy and MEDI4736 + tremelimumab combination therapy compared with SoC and each other using the FACT-BL questionnaire [ Time Frame: 4 years ]
  6. To assess the serum concentration of MEDI4736/tremelimumab of MEDI4736 monotherapy and MEDI4736 + tremelimumab combination therapy [ Time Frame: up to 6 months ]
  7. To investigate the immunogenicity of MEDI4736 monotherapy and MEDI4736 + tremelimumab combination therapy [ Time Frame: 4 years ]
  8. To assess the objective response rate (ORR) of MEDI4736 monotherapy in patients who are not cisplatin-eligible [ Time Frame: 4 years ]
  9. To assess the duration of response (DoR) of MEDI4736 monotherapy in patients who are not cisplatin-eligible [ Time Frame: 4 years ]

Other Outcome Measures:
  1. To use summary of adverse events to assess the safety of MEDI4736 monotherapy and MEDI4736 + tremelimumab combination therapy compared to SoC [ Time Frame: 4 years ]
    AEs (both in terms of MedDRA preferred terms and CTCAE grade) will be listed individually by patient. The number of patients experiencing each AE will be summarized by treatment arm and CTCAE grade.



Information from the National Library of Medicine

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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 Criteria:

  • Patients with histologically or cytologically documented, unresectable, Stage IV transitional cell carcinoma of the urothelium who have not been previously treated with first-line chemotherapy.
  • Patients eligible or ineligible for cisplatin-based chemotherapy. Cisplatin ineligibility is defined as meeting 1 of the following criteria: • Creatinine clearance (calculated or measured) <60 mL/min calculated by Cockcroft-Gault equation (using actual body weight) or by measured 24-hour urine collection for determination • Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 audiometric hearing loss • CTCAE Grade ≥2 peripheral neuropathy • New York Heart Association ≥Class III heart failure.
  • Tumor PD-L1 status, with Immunohistochemical (IHC) assay confirmed by a reference laboratory, must be known prior to randomization.

Exclusion Criteria:

  • Prior exposure to immune-mediated therapy, including but not limited to, other anti cytotoxic T-lymphocyte-associated protein 4 (CTLA 4), anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies, including therapeutic anticancer vaccines. Prior local intervesical chemotherapy or immunotherapy is allowed if completed at least 28 days prior to the initiation of study treatment.
  • History of allogenic organ transplantation that requires use of immunosuppressive agents.
  • Active or prior documented autoimmune or inflammatory disorders. The following are exceptions to this criterion: • Patients with vitiligo or alopecia • Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement • Any chronic skin condition that does not require systemic therapy • Patients without active disease in the last 3 years may be included but only after consultation with AstraZeneca • Patients with celiac disease controlled by diet alone may be included but only after consultation with AstraZeneca.
  • Brain metastases or spinal cord compression unless the patient's condition is stable and off steroids for at least 14 days prior to the start of study treatment. Patients with suspected or known brain metastases at screening should have an MRI (preferred)/CT, preferably with IV contrast to access baseline disease status.
  • Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
  • 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. Note: Patients, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of IP.

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): NCT02516241


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Contact: AstraZeneca Cancer Study Locator Service 1-877-400-4656 AstraZeneca@emergingmed.com

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Locations
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United States, California
Research Site Completed
Los Angeles, California, United States, 90095
Research Site Active, not recruiting
Stanford, California, United States, 94305
United States, Colorado
Research Site Active, not recruiting
Aurora, Colorado, United States, 80045
United States, Connecticut
Research Site Active, not recruiting
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Research Site Withdrawn
Washington, District of Columbia, United States, 20007
United States, Florida
Research Site Completed
Tampa, Florida, United States, 33612
United States, Georgia
Research Site Completed
Atlanta, Georgia, United States, 30322
United States, Kentucky
Research Site Active, not recruiting
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Research Site Withdrawn
Boston, Massachusetts, United States, 02114
Research Site Withdrawn
Boston, Massachusetts, United States, 02115
Research Site Active, not recruiting
Boston, Massachusetts, United States, 02215
Research Site Withdrawn
Boston, Massachusetts, United States, 02215
United States, Michigan
Research Site Active, not recruiting
Ann Arbor, Michigan, United States, 48109
Research Site Completed
Detroit, Michigan, United States, 48201
United States, Minnesota
Research Site Withdrawn
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Research Site Withdrawn
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Research Site Completed
Omaha, Nebraska, United States, 68130
United States, New York
Research Site Withdrawn
Bronx, New York, United States, 10467
Research Site Active, not recruiting
New York, New York, United States, 10021
Research Site Active, not recruiting
New York, New York, United States, 10029
United States, Ohio
Research Site Withdrawn
Cleveland, Ohio, United States, 44106
United States, Tennessee
Research Site Active, not recruiting
Memphis, Tennessee, United States, 38120
Research Site Completed
Nashville, Tennessee, United States, 37203
United States, Texas
Research Site Withdrawn
Houston, Texas, United States, 77030
United States, Washington
Research Site Active, not recruiting
Seattle, Washington, United States, 98101
Research Site Withdrawn
Seattle, Washington, United States, 98104
Australia
Research Site Active, not recruiting
Box Hill, Australia, 3128
Research Site Completed
Elizabeth Vale, Australia, 5112
Research Site Active, not recruiting
Macquarie University, Australia, 2109
Research Site Active, not recruiting
St Leonards, Australia, 2065
Research Site Active, not recruiting
Waratah, Australia, 2298
Austria
Research Site Completed
Linz, Austria, 4010
Research Site Withdrawn
Wien, Austria, 1020
Research Site Completed
Wien, Austria, 1090
Research Site Active, not recruiting
Wien, Austria, 1140
Belgium
Research Site Active, not recruiting
Brussels, Belgium, 1000
Research Site Active, not recruiting
Bruxelles, Belgium, 1200
Research Site Active, not recruiting
Leuven, Belgium, 3000
Research Site Active, not recruiting
Liège, Belgium, 4000
Brazil
Research Site Active, not recruiting
Barretos, Brazil, 14784-400
Research Site Active, not recruiting
Belo Horizonte, Brazil, 30380-472
Research Site Completed
Ijui, Brazil, 98700-000
Research Site Completed
Itajai, Brazil, 88310-110
Research Site Completed
Porto Alegre, Brazil, 90035-003
Research Site Active, not recruiting
Porto Alegre, Brazil, 90610-000
Research Site Active, not recruiting
Porto Alegre, Brazil, 91350-200
Research Site Completed
Rio de Janeiro, Brazil, 20231-050
Research Site Active, not recruiting
Rio de Janeiro, Brazil, 22793-080
Research Site Completed
Sao Paulo, Brazil, 01209-000
Research Site Completed
Sao Paulo, Brazil, 01321-001
Research Site Completed
Sao Paulo, Brazil, 01509-900
Research Site Active, not recruiting
São José do Rio Preto, Brazil, 15090-000
Research Site Withdrawn
São Paulo, Brazil, 01246-000
Canada, Alberta
Research Site Completed
Calgary, Alberta, Canada, T2N 4N2
Research Site Completed
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Research Site Completed
Kelowna, British Columbia, Canada, V1Y 5L3
Research Site Active, not recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Nova Scotia
Research Site Active, not recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Research Site Active, not recruiting
Hamilton, Ontario, Canada, L8V 5C2
Research Site Withdrawn
Kingston, Ontario, Canada, K7L 2V7
Research Site Completed
Newmarket, Ontario, Canada, L3Y 2P9
Research Site Completed
Oshawa, Ontario, Canada, L1G 2B9
Research Site Completed
Ottawa, Ontario, Canada, K1H 1C4
Research Site Active, not recruiting
Toronto, Ontario, Canada, M4N 3M5
Research Site Active, not recruiting
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Research Site Active, not recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Canada
Research Site Active, not recruiting
Quebec, Canada, G1R 3S1
China
Research Site Recruiting
Beijing, China, 100034
Research Site Recruiting
Beijing, China, 100039
Research Site Recruiting
Beijing, China, 100191
Research Site Not yet recruiting
Beijing, China, 100730
Research Site Recruiting
Changchun, China, 130012
Research Site Recruiting
Changsha, China, 410013
Research Site Recruiting
ChongQing, China, 400038
Research Site Withdrawn
Guangzhou, China, 510120
Research Site Recruiting
Hangzhou, China, 310009
Research Site Recruiting
Hangzhou, China, 310014
Research Site Not yet recruiting
Jinan, China, 250012
Research Site Recruiting
Nanjing, China, 210008
Research Site Recruiting
Shanghai, China, 200000
Research Site Recruiting
Shanghai, China, 200032
Research Site Recruiting
Shanghai, China, 200072
Research Site Recruiting
Shanghai, China, 200080
Research Site Recruiting
Shanghai, China, 200127
Research Site Recruiting
Shenyang, China, 110001
Research Site Recruiting
Tianjin, China, 300211
Research Site Recruiting
Xi'an, China, 710061
Research Site Recruiting
Xiamen, China, 361003
Denmark
Research Site Completed
Herlev, Denmark, 2730
Research Site Completed
København Ø, Denmark, 2100
Research Site Completed
Odense C, Denmark, 5000
Research Site Completed
Århus C, Denmark, 8000
France
Research Site Active, not recruiting
Bordeaux Cedex, France, 33075
Research Site Active, not recruiting
Bordeaux, France, 33000
Research Site Active, not recruiting
Caen Cedex, France, 14076
Research Site Active, not recruiting
Lyon Cedex 08, France, 69373
Research Site Completed
Marseille cedex 09, France, 13273
Research Site Completed
Paris Cedex 10, France, 75475
Research Site Completed
Poitiers Cedex, France, 86021
Research Site Active, not recruiting
Suresnes Cedex, France, 92151
Research Site Active, not recruiting
Toulouse, France, 31059
Research Site Active, not recruiting
Villejuif, France, 94805
Germany
Research Site Completed
Düsseldorf, Germany, 40225
Research Site Completed
Erlangen, Germany, 91054
Research Site Completed
Hannover, Germany, 30625
Research Site Completed
Heidelberg, Germany, 69120
Research Site Completed
Jena, Germany, 07747
Research Site Withdrawn
Lübeck, Germany, 23538
Research Site Active, not recruiting
München, Germany, 81675
Research Site Active, not recruiting
Münster, Germany, 48149
Greece
Research Site Active, not recruiting
Athens, Greece, 11528
Research Site Active, not recruiting
Heraklion, Greece, 711 11
Research Site Active, not recruiting
Holargos, Athens, Greece, 155 62
Research Site Active, not recruiting
Ilion, Greece
Research Site Active, not recruiting
Maroussi, Athens, Greece, 15125
Research Site Active, not recruiting
Patras, Greece, 26500
Research Site Completed
Thessaloniki, Greece, 56 429
Israel
Research Site Active, not recruiting
Haifa, Israel, 31096
Research Site Completed
Jerusalem, Israel, 91120
Research Site Active, not recruiting
Petach-Tikva, Israel, 4941492
Research Site Active, not recruiting
Ramat Gan, Israel, 5265601
Research Site Completed
Zerifin, Israel, 70300
Italy
Research Site Active, not recruiting
Arezzo, Italy, 52100
Research Site Withdrawn
Genova, Italy, 16100
Research Site Active, not recruiting
Meldola, Italy, 47014
Research Site Active, not recruiting
Milano, Italy, 20132
Research Site Active, not recruiting
Milano, Italy, 20133
Research Site Completed
Napoli, Italy, 80131
Research Site Active, not recruiting
Orbassano, Italy, 10043
Research Site Completed
Pavia, Italy, 27100
Research Site Completed
Roma, Italy, 00152
Research Site Active, not recruiting
San Giovanni Rotondo, Italy, 71013
Japan
Research Site Active, not recruiting
Akita-shi, Japan, 010-8543
Research Site Completed
Bunkyo-ku, Japan, 113-8603
Research Site Active, not recruiting
Fukuoka-shi, Japan, 811-1347
Research Site Completed
Hakata-shi, Japan, 812-0033
Research Site Active, not recruiting
Hirosaki-shi, Japan, 036-8563
Research Site Active, not recruiting
Hiroshima-shi, Japan, 730-8518
Research Site Completed
Izumo-shi, Japan, 693-8501
Research Site Completed
Kagoshima-shi, Japan, 890-8520
Research Site Active, not recruiting
Kanazawa-shi, Japan, 920-8641
Research Site Active, not recruiting
Kita-gun, Japan, 761-0793
Research Site Completed
Kobe-shi, Japan, 650-0047
Research Site Completed
Koshigaya-shi, Japan, 343-8555
Research Site Completed
Koto-ku, Japan, 135-8550
Research Site Active, not recruiting
Kumamoto-shi, Japan, 860-0008
Research Site Active, not recruiting
Kyoto-shi, Japan, 606-8507
Research Site Withdrawn
Matsumoto-shi, Japan, 399-8701
Research Site Active, not recruiting
Matsuyama-shi, Japan, 791-0280
Research Site Completed
Morioka-shi, Japan, 020-8505
Research Site Active, not recruiting
Nagasaki-shi, Japan, 852-8501
Research Site Completed
Nagoya-shi, Japan, 460-0001
Research Site Active, not recruiting
Nagoya-shi, Japan, 466-8560
Research Site Withdrawn
Niigata-shi, Japan, 951-8566
Research Site Completed
Osaka-shi, Japan, 541-8567
Research Site Completed
Osaka-shi, Japan, 545-8586
Research Site Active, not recruiting
Osakasayama-shi, Japan, 589-8511
Research Site Active, not recruiting
Saga-shi, Japan, 840-8571
Research Site Completed
Sagamihara-shi, Japan, 252-0315
Research Site Completed
Sakura-shi, Japan, 285-8741
Research Site Completed
Sapporo-shi, Japan, 060-8648
Research Site Active, not recruiting
Suita-shi, Japan, 565-0871
Research Site Completed
Takatsuki-shi, Japan, 569-8686
Research Site Completed
Yokohama-shi, Japan, 232-0024
Research Site Completed
Yokohama-shi, Japan, 236-0004
Korea, Republic of
Research Site Active, not recruiting
Incheon, Korea, Republic of, 21565
Research Site Active, not recruiting
Seongnam-si, Korea, Republic of, 13620
Research Site Completed
Seoul, Korea, Republic of, 02841
Research Site Active, not recruiting
Seoul, Korea, Republic of, 03080
Research Site Active, not recruiting
Seoul, Korea, Republic of, 03722
Research Site Active, not recruiting
Seoul, Korea, Republic of, 05505
Research Site Active, not recruiting
Seoul, Korea, Republic of, 135-710
Mexico
Research Site Active, not recruiting
Guadalajara, Mexico, 44280
Research Site Completed
León, Mexico, 37000
Research Site Completed
Mexico, D.F, Mexico, 01120
Research Site Completed
Mexico, Mexico, 06760
Research Site Withdrawn
Mexico, Mexico, 14080
Research Site Completed
Monterrey, Mexico, 64460
Research Site Completed
México, Mexico, 04739
Netherlands
Research Site Active, not recruiting
Amsterdam, Netherlands, 1066 CX
Research Site Active, not recruiting
Amsterdam, Netherlands, 1081 HV
Research Site Active, not recruiting
Breda, Netherlands, 4819 EV
Research Site Completed
Enschede, Netherlands, 7512 KZ
Research Site Active, not recruiting
Groningen, Netherlands, 9713 GZ
Research Site Completed
Leiden, Netherlands, 2333 ZA
Research Site Active, not recruiting
Maastricht, Netherlands, 6229 HX
Research Site Active, not recruiting
Nijmegen, Netherlands, 6525 GA
Poland
Research Site Completed
Gdańsk, Poland, 80-214
Research Site Terminated
Gdańsk, Poland, 80-462
Research Site Completed
Gdynia, Poland, 81-519
Research Site Completed
Gliwice, Poland, 44-101
Research Site Withdrawn
Katowice, Poland, 40-074
Research Site Withdrawn
Kielce, Poland, 25-734
Research Site Completed
Olsztyn, Poland, 10-228
Research Site Active, not recruiting
Otwock, Poland, 05-400
Research Site Withdrawn
Poznan, Poland, 60-780
Research Site Completed
Szczecin, Poland, 70-111
Research Site Completed
Warszawa, Poland, 02-781
Research Site Withdrawn
Wrocław, Poland, 50-556
Portugal
Research Site Withdrawn
Coimbra, Portugal, 3000-075
Research Site Withdrawn
Covilhã, Portugal, 6200-251
Research Site Active, not recruiting
Lisboa, Portugal, 1649-035
Research Site Withdrawn
Lisboa, Portugal, 1998-018
Research Site Completed
Loures, Portugal, 2674-514
Research Site Active, not recruiting
Porto, Portugal, 4099-001
Research Site Withdrawn
Porto, Portugal, 4200-319
Russian Federation
Research Site Active, not recruiting
Moscow, Russian Federation, 105229
Research Site Withdrawn
Moscow, Russian Federation, 107005
Research Site Withdrawn
Moscow, Russian Federation, 111123
Research Site Active, not recruiting
Moscow, Russian Federation, 115478
Research Site Withdrawn
Moscow, Russian Federation, 125367
Research Site Completed
Murmansk, Russian Federation, 183047
Research Site Active, not recruiting
Nizhnyi Novgorod, Russian Federation, 603001
Research Site Active, not recruiting
Obninsk, Russian Federation, 249036
Research Site Completed
Obninsk, Russian Federation, 249036
Research Site Active, not recruiting
Omsk, Russian Federation, 644013
Research Site Active, not recruiting
Saint Petersburg, Russian Federation, 191015
Research Site Active, not recruiting
Saint-Petersburg, Russian Federation, 197758
Research Site Withdrawn
Sochi, Russian Federation, 354057
Research Site Active, not recruiting
St. Petersburg, Russian Federation, 194354
Research Site Active, not recruiting
St. Petersburg, Russian Federation, 199178
Research Site Completed
St.Petersburg, Russian Federation, 191014
Research Site Withdrawn
Tjumen, Russian Federation, 625041
Research Site Active, not recruiting
Ufa, Russian Federation, 450054
Research Site Completed
Yaroslavl, Russian Federation, 150054
Spain
Research Site Active, not recruiting
Badajoz, Spain, 06008
Research Site Active, not recruiting
Badalona, Spain, 08916
Research Site Active, not recruiting
Barcelona, Spain, 08003
Research Site Active, not recruiting
Barcelona, Spain, 08035
Research Site Active, not recruiting
Barcelona, Spain, 08243
Research Site Active, not recruiting
Elche(Alicante), Spain, 03202
Research Site Active, not recruiting
Madrid, Spain, 28007
Research Site Active, not recruiting
Madrid, Spain, 28040
Research Site Active, not recruiting
Madrid, Spain, 28041
Research Site Active, not recruiting
Madrid, Spain, 28050
Research Site Completed
Pozuelo de Alarcon, Spain, 28223
Research Site Active, not recruiting
Santiago de Compostela, Spain, 15706
Research Site Active, not recruiting
Sevilla, Spain, 41013
Research Site Withdrawn
Valencia, Spain, 46009
Taiwan
Research Site Active, not recruiting
Kaohsiung, Taiwan
Research Site Active, not recruiting
Taichung, Taiwan, 00407
Research Site Active, not recruiting
Tainan, Taiwan, 704
Research Site Completed
Taipei, Taiwan, 10002
Research Site Active, not recruiting
Taipei, Taiwan, 112
Research Site Active, not recruiting
Taoyuan City, Taiwan, 333
Turkey
Research Site Withdrawn
Adana, Turkey
Research Site Completed
Ankara, Turkey, 06230
Research Site Withdrawn
Ankara, Turkey, 6500
Research Site Completed
Edirne, Turkey, 22030
Research Site Withdrawn
Istanbul, Turkey, 34662
Research Site Completed
Izmir, Turkey, 35100
United Kingdom
Research Site Completed
Cambridge, United Kingdom, CB2 0QQ
Research Site Active, not recruiting
Cardiff., United Kingdom, CF14 2TL
Research Site Active, not recruiting
Glasgow, United Kingdom, G12 0YN
Research Site Active, not recruiting
Leeds, United Kingdom, LS9 7TF
Research Site Active, not recruiting
London, United Kingdom, EC1A 7BE
Research Site Completed
London, United Kingdom, SE1 9RT
Research Site Active, not recruiting
Manchester, United Kingdom, M20 4BX
Research Site Active, not recruiting
Sheffield, United Kingdom, S10 2SJ
Research Site Active, not recruiting
Southampton, United Kingdom, SO16 6YD
Research Site Completed
Wirral, United Kingdom, CH63 4JY
Sponsors and Collaborators
AstraZeneca

Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02516241     History of Changes
Other Study ID Numbers: D419BC00001
First Posted: August 5, 2015    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Keywords provided by AstraZeneca:
Urothelial Cancer
Phase III
Additional relevant MeSH terms:
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Gemcitabine
Carboplatin
Durvalumab
Tremelimumab
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