Phase
Condition
N/ATreatment
Carboplatin + Gemcitabine
Durvalumab
Cisplatin + Gemcitabine
Clinical Study ID
Ages 18-130 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Patients with histologically or cytologically documented, unresectable, locallyadvanced or metastatic transitional cell carcinoma (transitional cell and mixedtransitional/non-transitional cell histologies) of the urothelium (including renalpelvis, ureters, urinary bladder, and urethra)
Patients who have not been previously treated with first-line chemotherapy. Patientswho have received prior definitive chemoradiation, adjuvant or neoadjuvant treatmentfor locally advanced disease are eligible provided that progression to locallyadvanced or metastatic disease has occurred >12 months from the last therapy [forchemoradiation and adjuvant treatment] or >12 months from the last surgery [forneoadjuvant treatment].
At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 targetlesion at baseline.
World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG)performance status (PS) of 0 or 1 at enrolment
Adequate organ and marrow function as defined in the protocol
Life expectancy ≥12 weeks in the opinion of the investigator
Evidence of post-menopausal status, or negative urinary or serum pregnancy test forfemale pre-menopausal patients.
Exclusion
Key Exclusion Criteria:
Prior exposure to immune-mediated therapy (with exclusion of Bacillus CalmetteGuerin), including but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD L1, oranti-PD-L2 antibodies, except therapeutic anticancer vaccines, which are permitted.Prior local intervesical chemotherapy or immunotherapy is allowed if completed atleast 28 days prior to the initiation of study treatment.
No severe concomitant condition that requires immunosuppression medication
Untreated central nervous system (CNS) metastases and/or carcinomatous meningitis
Patients who may be eligible for or are being considered for radical resectionduring the course of the study.
Any medical contraindications to platinum (cisplatin or carboplatin) based doubletchemotherapy and/or known allergy or hypersensitivity to any of the study drugs orany of the study drug excipients
Study Design
Connect with a study center
Research Site
Buenos Aires, C1120AAT
ArgentinaSite Not Available
Research Site
Ciudad de Buenos Aires, C1419AHL
ArgentinaSite Not Available
Research Site
Rosario, S2000DEJ
ArgentinaSite Not Available
Research Site
Box Hill, 3128
AustraliaSite Not Available
Research Site
Elizabeth Vale, 5112
AustraliaSite Not Available
Research Site
Kogarah, 2217
AustraliaSite Not Available
Research Site
Macquarie University, 2109
AustraliaSite Not Available
Research Site
Murdoch, 6150
AustraliaSite Not Available
Research Site
Orange, 2800
AustraliaSite Not Available
Research Site
South Brisbane, 4101
AustraliaSite Not Available
Research Site
St Albans, 3021
AustraliaSite Not Available
Research Site
Belo Horizonte, 30380-472
BrazilSite Not Available
Research Site
Curitiba, 80810-050
BrazilSite Not Available
Research Site
Fortaleza, 60336-232
BrazilSite Not Available
Research Site
Porto Alegre, 91350-200
BrazilSite Not Available
Research Site
Ribeirão Preto, 14048-900
BrazilSite Not Available
Research Site
Rio de Janeiro, 20231-050
BrazilSite Not Available
Research Site
Salvador, 41.950-610
BrazilSite Not Available
Research Site
Santa Maria, 97015-450
BrazilSite Not Available
Research Site
Sao Paulo, 01327-001
BrazilSite Not Available
Research Site
São José do Rio Preto, 15090-000
BrazilSite Not Available
Research Site
São Paulo, 01246-000
BrazilSite Not Available
Research Site
Burgas, 8000
BulgariaSite Not Available
Research Site
Pleven, 5800
BulgariaSite Not Available
Research Site
Plovdiv, 4000
BulgariaSite Not Available
Research Site
Sofia, 1527
BulgariaSite Not Available
Research Site
Varna, 9010
BulgariaSite Not Available
Research Site
Calgary, Alberta T2N 5G2
CanadaSite Not Available
Research Site
Edmonton, Alberta T6G 1Z2
CanadaSite Not Available
Research Site
Vancouver, British Columbia V5Z 4E6
CanadaSite Not Available
Research Site
Hamilton, Ontario L8V 5C2
CanadaSite Not Available
Research Site
Ottawa, Ontario K1H 8L6
CanadaSite Not Available
Research Site
Toronto, Ontario M5G IX6
CanadaSite Not Available
Research Site
Montreal, Quebec H3T 1E2
CanadaSite Not Available
Research Site
Sherbrooke, Quebec J1H 5N4
CanadaSite Not Available
Research Site
Beijing, 100191
ChinaSite Not Available
Research Site
Changchun, 130021
ChinaSite Not Available
Research Site
Changsha, 410008
ChinaSite Not Available
Research Site
Chengdu, 610072
ChinaSite Not Available
Research Site
Chongqing, 400038
ChinaSite Not Available
Research Site
Dalian, 116027
ChinaSite Not Available
Research Site
Guangzhou, 510060
ChinaSite Not Available
Research Site
Hangzhou, 310014
ChinaSite Not Available
Research Site
Harbin, 150049
ChinaSite Not Available
Research Site
Hefei, 230022
ChinaSite Not Available
Research Site
Jinan, 250012
ChinaSite Not Available
Research Site
Nanchang, 330006
ChinaSite Not Available
Research Site
Nanjing, 2100008
ChinaSite Not Available
Research Site
Shanghai, 200032
ChinaSite Not Available
Research Site
Shenyang, 110001
ChinaSite Not Available
Research Site
Suzhou, 215006
ChinaSite Not Available
Research Site
Tianjin,
ChinaSite Not Available
Research Site
Urumqi, 830000
ChinaSite Not Available
Research Site
Wuhan, 430022
ChinaSite Not Available
Research Site
Xi'an, 710061
ChinaSite Not Available
Research Site
Xiamen, 361003
ChinaSite Not Available
Research Site
Zhengzhou, 450052
ChinaSite Not Available
Research Site
Brno, 656 91
CzechiaSite Not Available
Research Site
Hradec Kralove, 500 05
CzechiaSite Not Available
Research Site
Olomouc, 77900
CzechiaSite Not Available
Research Site
Ostrava, 708 52
CzechiaSite Not Available
Research Site
Praha, 140 59
CzechiaSite Not Available
Research Site
Praha 2, 128 08
CzechiaSite Not Available
Research Site
Praha 8, 180 81
CzechiaSite Not Available
Research Site
Budapest, 1122
HungarySite Not Available
Research Site
Debrecen, 4032
HungarySite Not Available
Research Site
Gyula, 5700
HungarySite Not Available
Research Site
Györ, 9024
HungarySite Not Available
Research Site
Győr, 9024
HungarySite Not Available
Research Site
Kecskemét, 6000
HungarySite Not Available
Research Site
Szolnok, 5000
HungarySite Not Available
Research Site
Ahmedabad, 380015
IndiaSite Not Available
Research Site
Bangalore, 560055
IndiaSite Not Available
Research Site
Calicut, 673601
IndiaSite Not Available
Research Site
Gurgaon, 122001
IndiaSite Not Available
Research Site
Hubli, 580025
IndiaSite Not Available
Research Site
Hyderabad, 500084
IndiaSite Not Available
Research Site
Kolkata, 700160
IndiaSite Not Available
Research Site
Mangalore, 575018
IndiaSite Not Available
Research Site
Mysuru, 570017
IndiaSite Not Available
Research Site
Nagpur, 440012
IndiaSite Not Available
Research Site
Nasik, 422005
IndiaSite Not Available
Research Site
New Delhi, 110085
IndiaSite Not Available
Research Site
Pune, 411004
IndiaSite Not Available
Research Site
Vadodara, 390007
IndiaSite Not Available
Research Site
Haifa, 31096
IsraelSite Not Available
Research Site
Jerusalem, 91120
IsraelSite Not Available
Research Site
Kfar Saba, 95847
IsraelSite Not Available
Research Site
Petach-Tikva, 4941492
IsraelSite Not Available
Research Site
Ramat Gan, 52621
IsraelSite Not Available
Research Site
Arezzo, 52100
ItalySite Not Available
Research Site
Catania, 95126
ItalySite Not Available
Research Site
Milano, 20132
ItalySite Not Available
Research Site
Napoli, 80131
ItalySite Not Available
Research Site
Orbassano, 10043
ItalySite Not Available
Research Site
Parma, 43126
ItalySite Not Available
Research Site
Pavia, 27100
ItalySite Not Available
Research Site
Roma, 00100
ItalySite Not Available
Research Site
San Giovanni Rotondo, 71013
ItalySite Not Available
Research Site
Terni, 05100
ItalySite Not Available
Research Site
Verona, 37134
ItalySite Not Available
Research Site
Bunkyo-ku, 113-8603
JapanSite Not Available
Research Site
Chuo-ku, 104-0045
JapanSite Not Available
Research Site
Fukuoka-shi, 811-1347
JapanSite Not Available
Research Site
Hirosaki-shi, 036-8563
JapanSite Not Available
Research Site
Kanazawa-shi, 920-8641
JapanSite Not Available
Research Site
Kita-gun, 761-0793
JapanSite Not Available
Research Site
Koshigaya-shi, 343-8555
JapanSite Not Available
Research Site
Koto-ku, 135-8550
JapanSite Not Available
Research Site
Kumamoto-shi, 860-0008
JapanSite Not Available
Research Site
Kyoto-shi, 606-8507
JapanSite Not Available
Research Site
Miyazaki-city, 889-1692
JapanSite Not Available
Research Site
Nagasaki-shi, 852-8501
JapanSite Not Available
Research Site
Nagoya-shi, 467-0001
JapanSite Not Available
Research Site
Niigata-shi, 951-8520
JapanSite Not Available
Research Site
Osaka-shi, 545-8586
JapanSite Not Available
Research Site
Osakasayama-shi, 589-8511
JapanSite Not Available
Research Site
Shinjuku-ku, 160-8582
JapanSite Not Available
Research Site
Suita-shi, 565-0871
JapanSite Not Available
Research Site
Toyama-shi, 930-0194
JapanSite Not Available
Research Site
Tsukuba-shi, 305-8576
JapanSite Not Available
Research Site
Yokohama-shi, 232-0024
JapanSite Not Available
Research Site
Goyang-si, 10408
Korea, Republic ofSite Not Available
Research Site
Incheon, 21565
Korea, Republic ofSite Not Available
Research Site
Seoul, 02841
Korea, Republic ofSite Not Available
Research Site
Suwon, 16247
Korea, Republic ofSite Not Available
Research Site
Suwon-si, 442-723
Korea, Republic ofSite Not Available
Research Site
Bacolod, 6100
PhilippinesSite Not Available
Research Site
Baguio City, 2600
PhilippinesSite Not Available
Research Site
Cebu, 6000
PhilippinesSite Not Available
Research Site
Davao City, 8000
PhilippinesSite Not Available
Research Site
Iloilo City,
PhilippinesSite Not Available
Research Site
Legazpi City, 4500
PhilippinesSite Not Available
Research Site
Makati, 1229
PhilippinesSite Not Available
Research Site
Manila, 1015
PhilippinesSite Not Available
Research Site
Quezon City, 1104
PhilippinesSite Not Available
Research Site
Bialystok, 15-027
PolandSite Not Available
Research Site
Gdańsk, 80-952
PolandSite Not Available
Research Site
Grudziądz, 86-300
PolandSite Not Available
Research Site
Koszalin, 75-581
PolandSite Not Available
Research Site
Kraków, 31-501
PolandSite Not Available
Research Site
Lublin, 20-090
PolandSite Not Available
Research Site
Olsztyn, 10-228
PolandSite Not Available
Research Site
Otwock, 05-400
PolandSite Not Available
Research Site
Poznan, 60-693
PolandSite Not Available
Research Site
Radom, 26-600
PolandSite Not Available
Research Site
Warszawa, 02-781
PolandSite Not Available
Research Site
Wroclaw, 53-413
PolandSite Not Available
Research Site
Wrocław, 50-556
PolandSite Not Available
Research Site
Łódź, 93-509
PolandSite Not Available
Research Site
Ivanovo, 153040
Russian FederationSite Not Available
Research Site
Krasnoyarsk, 660133
Russian FederationSite Not Available
Research Site
Lipetsk, 398005
Russian FederationSite Not Available
Research Site
Moscow, 105229
Russian FederationSite Not Available
Research Site
Nizhniy Novgorod, 603137
Russian FederationSite Not Available
Research Site
Nizhny Novgorod, 603006
Russian FederationSite Not Available
Research Site
Omsk, 644013
Russian FederationSite Not Available
Research Site
Rostov-on-Don, 344037
Russian FederationSite Not Available
Research Site
Ryazan, 390046
Russian FederationSite Not Available
Research Site
Saint-Petersburg, 195067
Russian FederationSite Not Available
Research Site
St. Petersburg, 199178
Russian FederationSite Not Available
Research Site
St.-Petersburg,, 198205
Russian FederationSite Not Available
Research Site
St.Petersburg, 191014
Russian FederationSite Not Available
Research Site
Tyumen, 625041
Russian FederationSite Not Available
Research Site
Vologda, 160012
Russian FederationSite Not Available
Research Site
Barcelona, 8003
SpainSite Not Available
Research Site
Lugo, 27003
SpainSite Not Available
Research Site
Madrid, 28034
SpainSite Not Available
Research Site
Malaga, 29010
SpainSite Not Available
Research Site
Santander, 39008
SpainSite Not Available
Research Site
Sevilla, 41013
SpainSite Not Available
Research Site
Taichung, 40705
TaiwanSite Not Available
Research Site
Tainan, 704
TaiwanSite Not Available
Research Site
Taipei, 11217
TaiwanSite Not Available
Research Site
Taipei City, 10050
TaiwanSite Not Available
Research Site
Tao-Yuan, 333
TaiwanSite Not Available
Research Site
Taoyuan, 333
TaiwanSite Not Available
Research Site
Bangkok, 10400
ThailandSite Not Available
Research Site
Chom Thon, 50200
ThailandSite Not Available
Research Site
Khon Kaen, 40002
ThailandSite Not Available
Research Site
Lampang, 52000
ThailandSite Not Available
Research Site
Muang, 50200
ThailandSite Not Available
Research Site
Mueang, 50200
ThailandSite Not Available
Research Site
Songkla, 90110
ThailandSite Not Available
Research Site
Adana, 1260
TurkeySite Not Available
Research Site
Adapazari, 54290
TurkeySite Not Available
Research Site
Ankara, 06590
TurkeySite Not Available
Research Site
Edirne, 22030
TurkeySite Not Available
Research Site
Istanbul, 34030
TurkeySite Not Available
Research Site
Izmir,
TurkeySite Not Available
Research Site
Birmingham, Alabama 35294
United StatesSite Not Available
Research Site
Bakersfield, California 93309
United StatesSite Not Available
Research Site
Fountain Valley, California 92708
United StatesSite Not Available
Research Site
Fullerton, California 92835
United StatesSite Not Available
Research Site
Los Angeles, California 90095
United StatesSite Not Available
Research Site
Salinas, California 93901
United StatesSite Not Available
Research Site
Santa Barbara, California 93105
United StatesSite Not Available
Research Site
Santa Monica, California 90904
United StatesSite Not Available
Research Site
Truckee, California 96161
United StatesSite Not Available
Research Site
New Haven, Connecticut 06520
United StatesSite Not Available
Research Site
Washington, District of Columbia 20007
United StatesSite Not Available
Research Site
Orlando, Florida 32806
United StatesSite Not Available
Research Site
Chicago, Illinois 60611
United StatesSite Not Available
Research Site
Fort Wayne, Indiana 46804
United StatesSite Not Available
Research Site
Kansas City, Kansas 66160
United StatesSite Not Available
Research Site
Louisville, Kentucky 40202
United StatesSite Not Available
Research Site
New Orleans, Louisiana 70112
United StatesSite Not Available
Research Site
Grand Rapids, Michigan 49503
United StatesSite Not Available
Research Site
Bozeman, Montana 59715
United StatesSite Not Available
Research Site
Livingston, New Jersey 07039
United StatesSite Not Available
Research Site
Neptune, New Jersey 07753
United StatesSite Not Available
Research Site
Bronx, New York 10467
United StatesSite Not Available
Research Site
Lake Success, New York 11042
United StatesSite Not Available
Research Site
New Hyde Park, New York 11042
United StatesSite Not Available
Research Site
New York, New York 10065
United StatesSite Not Available
Research Site
Rochester, New York 14642
United StatesSite Not Available
Research Site
Philadelphia, Pennsylvania 19111
United StatesSite Not Available
Research Site
Sioux Falls, South Dakota 57104
United StatesSite Not Available
Research Site
Germantown, Tennessee 38138
United StatesSite Not Available
Research Site
Fort Worth, Texas 76104
United StatesSite Not Available
Research Site
Ha Noi, 100000
VietnamSite Not Available
Research Site
Hanoi, 10000
VietnamSite Not Available
Research Site
Ho Chi Minh, 70000
VietnamSite Not Available
Research Site
Ho Chi Minh city,
VietnamSite Not Available
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