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Brief Title: Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC

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.

INTRODUCTION

  • Org Study ID: D933RC00001
  • Secondary ID: 2018-001811-59
  • NTC ID: NCT03732677
  • Sponsor: 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

  • Overall Status
    Recruiting
  • Start Date
    November 16, 2018
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Pathologic complete response (pCR) rates at time of cystectomy

Primary Outcome 1 - Timeframe: Up to 6 months

Primary Outcome 2 - Measure: Event-free survival (EFS) per central review defined as time from randomization to event

Primary Outcome 2 - Timeframe: Up to 48 months

CONDITION

  • Muscle Invasive Bladder Cancer

ELIGIBILITY

Inclusion:
Patient resectable muscle-invasive bladder cancer with clinical stage T2-T4aN0/1M0 with transitional and mixed transitional cell histology

- Patients must be planning to undergo a radical cystectomy

- 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 (N2-N3) or metastatic (M1) 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

Gender: All

Minimum Age: 18 Years

Maximum Age: 130 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

LOCATION

Facility Status Contact
Facility: Research Site
Birmingham, Alabama 35294
United States
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Los Angeles, California 90095
United States
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Palo Alto, California 94304
United States
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New Haven, Connecticut 06520
United States
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Chicago, Illinois 60611
United States
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Iowa City, Iowa 52242
United States
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Westwood, Kansas 66205
United States
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Louisville, Kentucky 40202
United States
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Ann Arbor, Michigan 48109
United States
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New York, New York 10029
United States
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Rochester, New York 14642
United States
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Burlington, Vermont 05401
United States
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Milwaukee, Wisconsin 53226
United States
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Brisbane, Alberta 4122
Australia
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Elizabeth Vale, British Columbia 5112
Australia
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Macquarie University, Ontario 2109
Australia
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Melbourne, Ontario 3004
Australia
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Murdoch, Ontario 6150
Australia
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South Brisbane, Quebec 4101
Australia
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Brugge, Quebec 8000
Belgium
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Charleroi, 6000
Belgium
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Kortrijk, 8500
Belgium
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Leuven, 3000
Belgium
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Liège, 4000
Belgium
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Roeselare, 8800
Belgium
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Edmonton, T6G 1Z2
Canada
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Vancouver, V5Z 4E6
Canada
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Ottawa, K1H 8L6
Canada
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Toronto, M5G IX6
Canada
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Montreal, H2X 0C2
Canada
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Sherbrooke, J1H 5N4
Canada
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Antofagasta, 1267348
Chile
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Santiago, 7520349
Chile
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Temuco, 4810469
Chile
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Viña del Mar, 2540488
Chile
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Brno, 656 53
Czechia
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Brno, 656 91
Czechia
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Hradec Kralove, 500 05
Czechia
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Olomouc, 779 00
Czechia
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Praha 2, 128 08
Czechia
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Praha, 140 59
Czechia
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Angers Cedex 01, 49033
France
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Dijon, 21079
France
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Grenoble Cedex 09, 38043
France
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Montpellier, 34070
France
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Nimes, 30029
France
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Pierre Benite, 69495
France
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Poitiers Cedex, 86021
France
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Bergisch Gladbach, 51465
Germany
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Bonn, 53127
Germany
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Göttingen, 37075
Germany
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Herne, 44625
Germany
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Jena, 07747
Germany
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Köln, 50937
Germany
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Magdeburg, 39120
Germany
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Mannheim, 68167
Germany
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Münster, 48149
Germany
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Würzburg, 97080
Germany
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Haifa, 31096
Israel
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Jerusalem, 91120
Israel
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Kfar Saba, 95847
Israel
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Petach-Tikva, 4941492
Israel
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Ramat Gan, 52621
Israel
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Bari, 70124
Italy
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Firenze, 50134
Italy
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Milano, 20132
Italy
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Milano, 20133
Italy
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Napoli, 80131
Italy
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Orbassano, 10043
Italy
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Pozzuoli, 80078
Italy
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Verona, 37126
Italy
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Bunkyo-ku, 113-8603
Japan
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Fukuoka-shi, 811-1347
Japan
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Fukuoka, 812-8582
Japan
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Hirosaki-shi, 036-8563
Japan
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Hiroshima-shi, 730-8518
Japan
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Kanazawa-shi, 920-8641
Japan
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Koto-ku, 135-8550
Japan
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Kumamoto-shi, 860-0008
Japan
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Miyazaki-city, 889-1692
Japan
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Nagasaki-shi, 852-8501
Japan
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Nagoya-shi, 466-8560
Japan
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Niigata-shi, 951-8520
Japan
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Osaka-shi, 541-8567
Japan
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Osaka-shi, 545-8586
Japan
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Osakasayama-shi, 589-8511
Japan
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Sendai-shi, 980-0872
Japan
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Toyama-shi, 930-0194
Japan
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Tsukuba-shi, 305-8576
Japan
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Yokohama-shi, 232-0024
Japan
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Yokohama-shi, 241-8515
Japan
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Amsterdam, 1066 CX
Netherlands
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Breda, 4818 CK
Netherlands
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Rotterdam, 3015 GD
Netherlands
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Baguio City, 2600
Philippines
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Cebu, 6000
Philippines
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Davao City, 8000
Philippines
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Makati, 1229
Philippines
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Manila, 1015
Philippines
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Quezon City, 1101
Philippines
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Quezon City, 1104
Philippines
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Grudziądz, 86-300
Poland
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Krasnoyarsk, 660133
Russian Federation
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Moscow, 105077
Russian Federation
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Nizhniy Novgorod, 603074
Russian Federation
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Novosibirsk, 630007
Russian Federation
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Samara, 443031
Russian Federation
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St Petersburg, 194044
Russian Federation
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St. Petersburg, 197022
Russian Federation
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Ufa, 450000
Russian Federation
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Badalona, 08916
Spain
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Barcelona, 08035
Spain
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Córdoba, 14004
Spain
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Las Palmas de Gran Canaria, 35016
Spain
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Madrid, 28007
Spain
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Madrid, 28041
Spain
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Santander, 39008
Spain
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Sevilla, 41013
Spain
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Kaohsiung, 807
Taiwan
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Taichung, 40443
Taiwan
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Taichung, 40705
Taiwan
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Tainan, 704
Taiwan
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Tainan, 710
Taiwan
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Taipei City, 10050
Taiwan
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Taipei, 11217
Taiwan
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Taoyuan, 333
Taiwan
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Ankara, 06590
Turkey
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Edirne, 22030
Turkey
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Istanbul, 34030
Turkey
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İstanbul, 34457
Turkey
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Izmir, 35575
Turkey
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Karsiyaka, EH4 2XR
Turkey
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Edinburgh, E1 1BB
United Kingdom
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London, NG5 1PB
United Kingdom
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Sheffield, CH63 4JY
United Kingdom
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Wirral, 100000
United Kingdom
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Hanoi City, 700000
Vietnam
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Ho Chi Minh, 70000
Vietnam
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Hochiminh,
Vietnam
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