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Recruiting

Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Patients With Untreated Inoperable or Metastatic Urothelial Cancer - CA209-901

Updated: 21 May, 2018   |   ClinicalTrials.gov

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the trial guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 3

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 54

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Arm A: Investigational immunotherapy
Biological: ipilimumab Biological: nivolumab
Active Comparator: Arm B: Standard of care chemotherapy
Drug: carboplatin Drug: cisplatin Drug: gemcitabine
Experimental: Arm C: Investigational immunotherapy
Drug: cisplatin Drug: gemcitabine Biological: nivolumab
Active Comparator: Arm D: Standard of care chemotherapy
Drug: cisplatin Drug: gemcitabine

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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 Other protocol defined inclusion/exclusion criteria could apply

Have questions? Call 855-907-3286 or Email Us

Have questions?
Call 855-907-3286 or Email Us