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BRIEF 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

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


  • Org Study ID: D933RC00001
  • Secondary ID: 2018-001811-59
  • NCT ID: NCT03732677
  • NCT Alias:
  • Sponsor: AstraZeneca - Industry
  • Source: 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

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

Primary Outcomes:

Primary Outcome 1 - Measure: Pathologic complete response (pCR) rates at time of cystectomy following neoadjuvant treatment, as assessed by central pathology review

Primary Outcome 1 - Time Frame: Up to 36 months

Primary Outcome 2 - Measure: 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

Primary Outcome 2 - Time Frame: Up to 48 months

Condition:

  • Muscle Invasive Bladder Cancer

Eligibility

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

- 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
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Gender: All

Minimum Age: 18 Years

Maximum Age: 130 Years

Healthy Volunteers: No

Overall Contact

Name: AstraZeneca Clinical Study Information Center

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

Locations

Facility Status Contact
Research Site
Birmingham, Alabama 35294
United States
Not yet recruiting
Research Site
Fountain Valley, California 92708
United States
Withdrawn
Research Site
Fullerton, California 92835
United States
Withdrawn
Research Site
Los Angeles, California 90095
United States
Not yet recruiting
Research Site
Monterey, California 93940
United States
Withdrawn
Research Site
Salinas, California 93901
United States
Withdrawn
Research Site
Santa Rosa, California 95403
United States
Withdrawn
Research Site
Stanford, California 94305-5824
United States
Not yet recruiting
Research Site
Denver, Colorado 80211
United States
Withdrawn
Research Site
New Haven, Connecticut 06520
United States
Not yet recruiting
Research Site
Tampa, Florida 33612
United States
Withdrawn
Research Site
Chicago, Illinois 60611
United States
Not yet recruiting
Research Site
Iowa City, Iowa 52242
United States
Not yet recruiting
Research Site
Westwood, Kansas 66205
United States
Not yet recruiting
Research Site
Louisville, Kentucky 40202
United States
Recruiting
Research Site
New Orleans, Louisiana 70112
United States
Not yet recruiting
Research Site
Baltimore, Maryland 21204
United States
Recruiting
Research Site
Ann Arbor, Michigan 48109
United States
Not yet recruiting
Research Site
Detroit, Michigan 48201
United States
Not yet recruiting
Research Site
Neptune, New Jersey 07754
United States
Withdrawn
Research Site
New Brunswick, New Jersey 08903
United States
Withdrawn
Research Site
New York, New York 10029
United States
Not yet recruiting
Research Site
Rochester, New York 14642
United States
Not yet recruiting
Research Site
Durham, North Carolina 27710
United States
Not yet recruiting
Research Site
Columbus, Ohio 43210
United States
Withdrawn
Research Site
Bethlehem, Pennsylvania 18015
United States
Recruiting
Research Site
Providence, Rhode Island 02903
United States
Not yet recruiting
Research Site
Burlington, Vermont 05401
United States
Not yet recruiting
Research Site
Milwaukee, Wisconsin 53226
United States
Not yet recruiting
Research Site
Box Hill, 3128
Australia
Recruiting
Research Site
Elizabeth Vale, 5112
Australia
Recruiting
Research Site
Herston, 4029
Australia
Recruiting
Research Site
Macquarie University, 2109
Australia
Recruiting
Research Site
Murdoch, 6150
Australia
Recruiting
Research Site
Prahran, 3004
Australia
Recruiting
Research Site
South Brisbane, 4101
Australia
Recruiting
Research Site
Brugge, 8000
Belgium
Not yet recruiting
Research Site
Charleroi, 6000
Belgium
Not yet recruiting
Research Site
Kortrijk, 8500
Belgium
Not yet recruiting
Research Site
Leuven, 3000
Belgium
Not yet recruiting
Research Site
Liège, 4000
Belgium
Not yet recruiting
Research Site
Barretos, 14784-400
Brazil
Not yet recruiting
Research Site
Passo Fundo, 99010-080
Brazil
Not yet recruiting
Research Site
Porto Alegre, 90020-090
Brazil
Recruiting
Research Site
Porto Alegre, 90470-340
Brazil
Recruiting
Research Site
Porto Alegre, 90610-000
Brazil
Not yet recruiting
Research Site
Porto Alegre, 91350-200
Brazil
Recruiting
Research Site
Rio de Janeiro, 20231-050
Brazil
Not yet recruiting
Research Site
Sao Paulo, 01323-903
Brazil
Not yet recruiting
Research Site
Sao Paulo, 01509-900
Brazil
Not yet recruiting
Research Site
Sao Paulo, 04101-000
Brazil
Withdrawn
Research Site
São José do Rio Preto, 15090-000
Brazil
Recruiting
Research Site
São Paulo, 01246-000
Brazil
Not yet recruiting
Research Site
São Paulo, 03102-002
Brazil
Recruiting
Research Site
Edmonton, Alberta T6G 1Z2
Canada
Recruiting
Research Site
Vancouver, British Columbia V5Z 4E6
Canada
Recruiting
Research Site
Hamilton, Ontario L8V 5C2
Canada
Not yet recruiting
Research Site
London, Ontario N6A 4L6
Canada
Not yet recruiting
Research Site
Ottawa, Ontario K1H 8L6
Canada
Recruiting
Research Site
Toronto, Ontario M5G IX6
Canada
Recruiting
Research Site
Montreal, Quebec H2X 3E4
Canada
Not yet recruiting
Research Site
Sherbrooke, Quebec J1H 5N4
Canada
Not yet recruiting
Research Site
Antofagasta, 1267348
Chile
Not yet recruiting
Research Site
Puerto Montt, 5480000
Chile
Not yet recruiting
Research Site
Santiago de Chile, 6770128
Chile
Not yet recruiting
Research Site
Santiago, 7520349
Chile
Not yet recruiting
Research Site
Viña del Mar, 2540488
Chile
Not yet recruiting
Research Site
Hradec Kralove, 500 05
Czechia
Recruiting
Research Site
Olomouc, 779 00
Czechia
Not yet recruiting
Research Site
Praha 5, 150 06
Czechia
Not yet recruiting
Research Site
Angers Cedex 01, 49033
France
Not yet recruiting
Research Site
Dijon, 21079
France
Not yet recruiting
Research Site
Nimes, 30029
France
Not yet recruiting
Research Site
Pierre Benite, 69495
France
Not yet recruiting
Research Site
Poitiers Cedex, 86021
France
Not yet recruiting
Research Site
Rouen, F-76031 CE
France
Not yet recruiting
Research Site
Fürth, 90763
Germany
Not yet recruiting
Research Site
Köln, 50937
Germany
Not yet recruiting
Research Site
Magdeburg, 39120
Germany
Not yet recruiting
Research Site
Ulm, 89081
Germany
Not yet recruiting
Research Site
Würzburg, 97080
Germany
Not yet recruiting
Research Site
Haifa, 31096
Israel
Recruiting
Research Site
Jerusalem, 91120
Israel
Recruiting
Research Site
Kfar Saba, 95847
Israel
Recruiting
Research Site
Petach-Tikva, 4941492
Israel
Recruiting
Research Site
Ramat Gan, 52621
Israel
Not yet recruiting
Research Site
Bologna, 40138
Italy
Not yet recruiting
Research Site
Firenze, 50134
Italy
Not yet recruiting
Research Site
Milano, 20133
Italy
Not yet recruiting
Research Site
Napoli, 80131
Italy
Not yet recruiting
Research Site
Orbassano, 10043
Italy
Not yet recruiting
Research Site
Bunkyo-ku, 113-8603
Japan
Recruiting
Research Site
Fukuoka-shi, 811-1347
Japan
Recruiting
Research Site
Fukuoka, 812-8582
Japan
Recruiting
Research Site
Hirosaki-shi, 036-8563
Japan
Recruiting
Research Site
Kanazawa-shi, 920-8641
Japan
Recruiting
Research Site
Koto-ku, 135-8550
Japan
Recruiting
Research Site
Miyazaki-city, 889-1692
Japan
Recruiting
Research Site
Nagasaki-shi, 852-8501
Japan
Recruiting
Research Site
Nagoya-shi, 466-8560
Japan
Not yet recruiting
Research Site
Niigata-shi, 951-8520
Japan
Recruiting
Research Site
Osaka-shi, 541-8567
Japan
Recruiting
Research Site
Osaka-shi, 545-0051
Japan
Recruiting
Research Site
Osakasayama-shi, 589-8511
Japan
Recruiting
Research Site
Shinjuku-ku, 160-8582
Japan
Withdrawn
Research Site
Toyama-shi, 930-0194
Japan
Recruiting
Research Site
Tsukuba-shi, 305-8576
Japan
Not yet recruiting
Research Site
Yokohama-shi, 232-0024
Japan
Recruiting
Research Site
Yokohama-shi, 241-8515
Japan
Recruiting
Research Site
Daegu, 41404
Korea, Republic of
Recruiting
Research Site
Goyang-si, 10408
Korea, Republic of
Recruiting
Research Site
Incheon, 21565
Korea, Republic of
Recruiting
Research Site
Seongnam, 13620
Korea, Republic of
Recruiting
Research Site
Seoul, 03080
Korea, Republic of
Recruiting
Research Site
Seoul, 136-705
Korea, Republic of
Recruiting
Research Site
Amsterdam, 1066 CX
Netherlands
Recruiting
Research Site
Amsterdam, 1081 HV
Netherlands
Not yet recruiting
Research Site
Breda, 4819 EV
Netherlands
Not yet recruiting
Research Site
Rotterdam, 3015 GD
Netherlands
Not yet recruiting
Research Site
Baguio City, 2600
Philippines
Not yet recruiting
Research Site
Cebu, 6000
Philippines
Recruiting
Research Site
Davao City, 8000
Philippines
Recruiting
Research Site
Makati, 1229
Philippines
Not yet recruiting
Research Site
Manila, 1015
Philippines
Not yet recruiting
Research Site
Quezon City, 1104
Philippines
Not yet recruiting
Research Site
Quezon City,
Philippines
Not yet recruiting
Research Site
Bialystok, 15-027
Poland
Recruiting
Research Site
Gdańsk, 80-952
Poland
Recruiting
Research Site
Grudziądz, 86-300
Poland
Recruiting
Research Site
Koszalin, 75-581
Poland
Recruiting
Research Site
Olsztyn, 10-228
Poland
Recruiting
Research Site
Poznan, 60-693
Poland
Recruiting
Research Site
Radom, 26-600
Poland
Withdrawn
Research Site
Warszawa, 02-781
Poland
Recruiting
Research Site
Wroclaw, 53-413
Poland
Recruiting
Research Site
Ivanovo, 153040
Russian Federation
Withdrawn
Research Site
Krasnoyarsk, 660133
Russian Federation
Recruiting
Research Site
Moscow, 105077
Russian Federation
Withdrawn
Research Site
Nizhniy Novgorod, 603074
Russian Federation
Recruiting
Research Site
Omsk, 644013
Russian Federation
Recruiting
Research Site
Samara, 443031
Russian Federation
Recruiting
Research Site
St. Petersburg, 194017
Russian Federation
Recruiting
Research Site
St. Petersburg, 194354
Russian Federation
Recruiting
Research Site
Vologda, 160012
Russian Federation
Recruiting
Research Site
Badalona, 08916
Spain
Not yet recruiting
Research Site
Barcelona, 08035
Spain
Not yet recruiting
Research Site
Córdoba, 14004
Spain
Not yet recruiting
Research Site
Las Palmas de Gran Canaria, 35016
Spain
Not yet recruiting
Research Site
Madrid, 28007
Spain
Not yet recruiting
Research Site
Madrid, 28041
Spain
Not yet recruiting
Research Site
Santander, 39008
Spain
Not yet recruiting
Research Site
Sevilla, 41013
Spain
Not yet recruiting
Research Site
Kaohsiung, 807
Taiwan
Recruiting
Research Site
Taichung, 404
Taiwan
Recruiting
Research Site
Taichung, 40705
Taiwan
Not yet recruiting
Research Site
Tainan County,
Taiwan
Recruiting
Research Site
Tainan, 704
Taiwan
Recruiting
Research Site
Taipei City, 10050
Taiwan
Recruiting
Research Site
Taipei, 11217
Taiwan
Recruiting
Research Site
Taoyuan City, 333
Taiwan
Not yet recruiting
Research Site
Ankara, 06590
Turkey
Recruiting
Research Site
Edirne, 22030
Turkey
Recruiting
Research Site
Istanbul, 34030
Turkey
Recruiting
Research Site
Izmir,
Turkey
Recruiting
Research Site
Edinburgh, EH4 2XR
United Kingdom
Not yet recruiting
Research Site
Guildford, GU2 7WG
United Kingdom
Not yet recruiting
Research Site
London, EC1A 7BE
United Kingdom
Not yet recruiting
Research Site
Nottingham, NG5 1PB
United Kingdom
Not yet recruiting
Research Site
Sheffield, S10 2SJ
United Kingdom
Not yet recruiting
Research Site
Wirral, CH63 4JY
United Kingdom
Not yet recruiting
Research Site
Ha Noi, 100000
Vietnam
Recruiting
Research Site
Ho Chi Minh, 700000
Vietnam
Recruiting