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Active (not recruiting) Phase 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

Phase 3 – large-scale trial before approval
Conditions: Urothelial Cancer

Sponsor: Bristol-Myers Squibb

trial.available_in: БГ
Overview
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.
Who can participate
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
Locations 28
Argentina (1)
Local Institution - 0005
Capital Federal , Buenos Aires
Australia (1)
Local Institution - 0096
Waratah , New South Wales
Brazil (1)
Local Institution - 0017
Brasília , Federal District
Canada (1)
Local Institution - 0053
Halifax , Nova Scotia
Chile (1)
Local Institution - 0010
Santiago , Santiago Metropolitan
China (1)
Local Institution - 0171
Beijing , Beijing Municipality
Czech Republic (1)
Local Institution - 0160
Brno
Denmark (1)
Local Institution - 0190
Aalborg
Finland (1)
Local Institution - 0060
Helsinki
France (1)
Local Institution - 0091
Nîmes , Gard
Greece (1)
Local Institution - 0102
Athens
Israel (1)
Local Institution - 0199
Kfar Saba
Italy (1)
Local Institution - 0108
Arezzo
Japan (1)
Local Institution - 0136
Hirosaki , Aomori
Mexico (1)
Local Institution - 0129
Mexico City , Mexico City
Netherlands (1)
Local Institution - 0022
Amsterdam , North Holland
Norway (1)
Local Institution - 0074
Bergen
Peru (1)
Local Institution - 0031
Lima
Poland (1)
Local Institution - 0189
Bydgoszcz
Romania (1)
Local Institution - 0191
Cluj-Napoca , Cluj
Russia (1)
Local Institution
Moscow
Singapore (1)
Local Institution - 0192
Singapore , Central Singapore
South Korea (1)
Local Institution - 0125
Goyang-si , Gyeonggido
Spain (1)
Local Institution - 0070
A Coruña
Sweden (1)
Local Institution - 0075
Jönköping
Taiwan (1)
Local Institution - 0156
Kaohsiung City
Turkey (1)
Local Institution - 0194
Ankara
United States (1)
Local Institution - 0001
Anchorage , Alaska
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
24.03.2017
Completion date
15.05.2026
Registry ID
NCT03036098
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.