Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care Chemotherapy in Treatment of Patients With Untreated Inoperable or Metastatic Urothelial Cancer (CheckMate901)

The purpose of this study is to determine whether an investigational immunotherapy nivolumab in combination with ipilimumab is more effective than standard of care chemotherapy in treating patients with previously untreated inoperable or metastatic urothelial cancer.

Inclusion Criteria:
• Metastatic or inoperable urothelial cancer
• Must have at least 1 lesion with measurable disease
• Must have full activity or, if limited, must be able to walk and carry out activities such as light house work or office work
• No prior systemic chemotherapy treatment in the metastatic setting

Exclusion Criteria:
• Patients with disease that is suitable for local therapy administered with curative intent
• Patients with active brain metastases or leptomeningeal metastases
• Patients with active, known or suspected autoimmune disease
• Prior treatment with an anti-PD1, anti-PDL1, anti-PDL2, anti-CD137, or anti-CTLA4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Phase III
Brendan Curti, M.D.
BMS (Bristol-Myers Squibb)
  • Providence Cancer Institute Franz Clinic