Bladder Cancer Clinical Trial
Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC
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
Eligibility Criteria
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
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There are 184 Locations for this study
Birmingham Alabama, 35294, United States
Los Angeles California, 90095, United States
Palo Alto California, 94304, United States
New Haven Connecticut, 06520, United States
Chicago Illinois, 60611, United States
Geneva Illinois, 60134, United States
Iowa City Iowa, 52242, United States
Westwood Kansas, 66205, United States
Louisville Kentucky, 40202, United States
New Orleans Louisiana, 70112, United States
Towson Maryland, 21204, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48201, United States
New York New York, 10029, United States
Rochester New York, 14642, United States
Bethlehem Pennsylvania, 18015, United States
Burlington Vermont, 05401, United States
Milwaukee Wisconsin, 53226, United States
Brisbane , 4122, Australia
Elizabeth Vale , 5112, Australia
Macquarie University , 2109, Australia
Melbourne , 3004, Australia
Murdoch , 6150, Australia
South Brisbane , 4101, Australia
Brugge , 8000, Belgium
Charleroi , 6000, Belgium
Kortrijk , 8500, Belgium
Leuven , 3000, Belgium
Liège , 4000, Belgium
Roeselare , 8800, Belgium
Barretos , 14784, Brazil
Porto Alegre , 90020, Brazil
Porto Alegre , 90470, Brazil
Porto Alegre , 90610, Brazil
Porto Alegre , 91350, Brazil
Rio de Janeiro , 20231, Brazil
Santa Maria , 97015, Brazil
Sao Paulo , 01323, Brazil
Sao Paulo , 01509, Brazil
São José do Rio Preto , 15090, Brazil
São Paulo , 01246, Brazil
São Paulo , 03102, Brazil
Edmonton Alberta, T6G 1, Canada
Vancouver British Columbia, V5Z 4, Canada
London Ontario, N6A 5, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M5G I, Canada
Montreal Quebec, H2X 0, Canada
Sherbrooke Quebec, J1H 5, Canada
Antofagasta , 12673, Chile
Puerto Montt , 54800, Chile
Santiago , 75203, Chile
Temuco , 48102, Chile
Temuco , 48104, Chile
Viña del Mar , 25404, Chile
Brno , 656 5, Czechia
Brno , 656 9, Czechia
Hradec Kralove , 500 0, Czechia
Olomouc , 779 0, Czechia
Praha 2 , 128 0, Czechia
Praha 8 , 180 8, Czechia
Praha , 140 5, Czechia
Angers Cedex 01 , 49033, France
Dijon , 21079, France
Grenoble Cedex 09 , 38043, France
Montpellier , 34070, France
Nimes , 30029, France
Pierre Benite , 69495, France
Poitiers Cedex , 86021, France
Rouen , F-760, France
Bergisch Gladbach , 51465, Germany
Bonn , 53127, Germany
Erlangen , 91054, Germany
Göttingen , 37075, Germany
Herne , 44625, Germany
Jena , 07747, Germany
Köln , 50937, Germany
Magdeburg , 39120, Germany
Mannheim , 68167, Germany
Münster , 48149, Germany
Nürnberg , 90491, Germany
Oldenburg , 23758, Germany
Regensburg , 93053, Germany
Ulm , 89081, Germany
Würzburg , 97080, Germany
Haifa , 31096, Israel
Jerusalem , 91120, Israel
Kfar Saba , 95847, Israel
Petach-Tikva , 49414, Israel
Ramat Gan , 52621, Israel
Bari , 70124, Italy
Bologna , 40138, Italy
Firenze , 50134, Italy
Milano , 20132, Italy
Milano , 20133, Italy
Napoli , 80131, Italy
Orbassano , 10043, Italy
Pozzuoli , 80078, Italy
Verona , 37126, Italy
Bunkyo-ku , 113-8, Japan
Fukuoka-shi , 811-1, Japan
Fukuoka , 812-8, Japan
Hirosaki-shi , 036-8, Japan
Hiroshima-shi , 730-8, Japan
Kanazawa-shi , 920-8, Japan
Koto-ku , 135-8, Japan
Kumamoto-shi , 860-0, Japan
Miyazaki-city , 889-1, Japan
Nagasaki-shi , 852-8, Japan
Nagoya-shi , 466-8, Japan
Niigata-shi , 951-8, Japan
Osaka-shi , 541-8, Japan
Osaka-shi , 545-8, Japan
Osakasayama-shi , 589-8, Japan
Sendai-shi , 980-0, Japan
Toyama-shi , 930-0, Japan
Tsukuba-shi , 305-8, Japan
Yokohama-shi , 232-0, Japan
Yokohama-shi , 241-8, Japan
Daegu , 41404, Korea, Republic of
Goyang-si , 10408, Korea, Republic of
Gyeonggi-do , 13620, Korea, Republic of
Incheon , 21565, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 136-7, Korea, Republic of
Amsterdam , 1066 , Netherlands
Amsterdam , 1081 , Netherlands
Breda , 4818 , Netherlands
Rotterdam , 3015 , Netherlands
Baguio City , 2600, Philippines
Cebu , 6000, Philippines
Davao City , 8000, Philippines
Makati , 1229, Philippines
Manila , 1015, Philippines
Quezon City , 1101, Philippines
Quezon City , 1104, Philippines
Bialystok , 15-02, Poland
Gdańsk , 80-21, Poland
Grudziądz , 86-30, Poland
Koszalin , 75-58, Poland
Kraków , 30-51, Poland
Olsztyn , 10-22, Poland
Ostrołęka , 07-41, Poland
Poznan , 60-69, Poland
Warszawa , 02-78, Poland
Wroclaw , 53-41, Poland
Krasnoyarsk , 66013, Russian Federation
Moscow , 10507, Russian Federation
Nizhniy Novgorod , 60307, Russian Federation
Novosibirsk , 63000, Russian Federation
Samara , 44303, Russian Federation
St Petersburg , 19404, Russian Federation
St. Petersburg , 19401, Russian Federation
St. Petersburg , 19435, Russian Federation
St. Petersburg , 19702, Russian Federation
Ufa , 45000, Russian Federation
Vologda , 16001, Russian Federation
Badalona , 08916, Spain
Barcelona , 08035, Spain
Córdoba , 14004, Spain
Las Palmas de Gran Canaria , 35016, Spain
Madrid , 28007, Spain
Madrid , 28041, Spain
Santander , 39008, Spain
Sevilla , 41013, Spain
Kaohsiung , 807, Taiwan
Taichung , 404, Taiwan
Taichung , 40705, Taiwan
Tainan , 704, Taiwan
Tainan , 710, Taiwan
Taipei City , 10050, Taiwan
Taipei , 11217, Taiwan
Taoyuan City , 333, Taiwan
Ankara , 06590, Turkey
Edirne , 22030, Turkey
Istanbul , 34030, Turkey
İstanbul , 34457, Turkey
Izmir , , Turkey
Karsiyaka , 35575, Turkey
Edinburgh , EH4 2, United Kingdom
London , E1 1B, United Kingdom
Nottingham , NG5 1, United Kingdom
Sheffield , S10 2, United Kingdom
Wirral , CH63 , United Kingdom
Hanoi , 10000, Vietnam
Ho Chi Minh , 70000, Vietnam
Hochiminh , 70000, Vietnam
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