Active, Not Recruiting
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 - CA209-901
Updated: 19 August, 2024 | ClinicalTrials.gov
Phase
Gender(s)
Age Range
Active, Not Recruiting
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
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