A Phase 3, Open-label, Randomized Study of Nivolumab Combined With Ipilimumab Versus Standard of Care Chemotherapy in Participants With Previously Untreated Unresectable or Metastatic Urothelial Cancer

Condition: Urothelial Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03036098

Sponsor: Bristol-Myers Squibb

Phase: Phase 3

Eligibility:

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:

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