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Активно (без набиране) Фаза 3 NCT03036098

Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer

Фаза 3 – широко изпитване преди одобрение
Заболявания: Urothelial Cancer

Спонсор: Bristol-Myers Squibb

Налично на: БГ
Обобщение
The purpose of this study is to determine whether an investigational immunotherapy nivolumab in combination with ipilimumab or in combination with standard of care chemotherapy is more effective than standard of care chemotherapy alone in treating participants with previously untreated inoperable or metastatic urothelial cancer.
Кой може да участва
Inclusion Criteria: * Histological or cytological evidence of metastatic or surgically inoperable transitional cell cancer (TCC) of the urothelium involving the renal pelvis, ureter, bladder or urethra * No prior systemic chemotherapy for metastatic or surgically inoperable urothelial cancer (UC) * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 * Women and men must agree to follow specific methods of contraception, if applicable Exclusion Criteria: * Disease that is suitable for local therapy administered with curative intent * Any serious or uncontrolled medical disorder in the opinion of the investigator that may increase the risk associated with study participation or study drug administration or interfere with the interpretation of study results * Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways Other protocol-defined inclusion/exclusion criteria apply
Места на провеждане 28
Argentina (1)
Local Institution - 0005
Capital Federal , Buenos Aires
Австралия (1)
Local Institution - 0096
Waratah , New South Wales
Бразилия (1)
Local Institution - 0017
Brasília , Federal District
Канада (1)
Local Institution - 0053
Halifax , Nova Scotia
Chile (1)
Local Institution - 0010
Santiago , Santiago Metropolitan
Китай (1)
Local Institution - 0171
Beijing , Beijing Municipality
Чехия (1)
Local Institution - 0160
Brno
Дания (1)
Local Institution - 0190
Aalborg
Финландия (1)
Local Institution - 0060
Helsinki
Франция (1)
Local Institution - 0091
Nîmes , Gard
Гърция (1)
Local Institution - 0102
Athens
Израел (1)
Local Institution - 0199
Kfar Saba
Италия (1)
Local Institution - 0108
Arezzo
Япония (1)
Local Institution - 0136
Hirosaki , Aomori
Mexico (1)
Local Institution - 0129
Mexico City , Mexico City
Нидерландия (1)
Local Institution - 0022
Amsterdam , North Holland
Норвегия (1)
Local Institution - 0074
Bergen
Peru (1)
Local Institution - 0031
Lima
Полша (1)
Local Institution - 0189
Bydgoszcz
Румъния (1)
Local Institution - 0191
Cluj-Napoca , Cluj
Russia (1)
Local Institution
Moscow
Сингапур (1)
Local Institution - 0192
Singapore , Central Singapore
Южна Корея (1)
Local Institution - 0125
Goyang-si , Gyeonggido
Испания (1)
Local Institution - 0070
A Coruña
Швеция (1)
Local Institution - 0075
Jönköping
Taiwan (1)
Local Institution - 0156
Kaohsiung City
Турция (1)
Local Institution - 0194
Ankara
САЩ (1)
Local Institution - 0001
Anchorage , Alaska
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
24.03.2017
Крайна дата
15.05.2026
Регистрационен номер
NCT03036098
Източник
anzctr
Запитване за медицински туризъм

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