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Clinical Trials

Topic   Metastatic Urothelial Cancer
Title   A Phase 3, Open-label, Randomized Study of Nivolumab Combined with Ipilimumab, or with Standard of Care Chemotherapy, versus Standard of Care Chemotherapy in Participants with Previously Untreated Unresectable or Metastatic Urothelial Cancer
Summary   The purpose of this study is to compare the efficacy of Nivolumab with Ipilimumab (both immunotherapy drugs) versus standard of care chemotherapy in Cisplatin-ineligible participants with previously untreated, unresectable or metastatic urothelial carcinoma (UC). This study has 2 treatment arms. Participants in one arm will receive combination therapy (Nivolumab + Ipilimumab) for up to 4 doses, followed by Nivolumab every 4 weeks. Participants in the other arm will receive up to 6 cycles of standard of care chemotherapy. For more information, please visit
Description   The primary purpose of this study is to test a combination of Nivolumab and Ipilimumab for Urothelial Cancer, Doctors are studying this combination to learn more about its effectiveness compared to the treatment that is most commonly given for Urothelial Cancer.

The study aims to demonstrate that treatment with Nivolumab combined with Ipilimumab will improve efficacy in Cisplatin-ineligible participants with previously untreated unresectable or metastatic urothelial cancer.
IRB Number   WIRB Protocol #20171048
Inclusion/Notes   To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • This study is for patients age 18 and older.
  • Have bladder or urinary tract cancer that has spread or cannot be removed by surgery
  • Have not received systematic chemotherapy for Urinary tract cancer
  • Do not have cancer that spread to the brain
  • Do not have an autoimmune disease (for example lupus, celiac disease, rheumatoid arthritis)
  • Histological or cytological evidence of metastatic or surgically unresectable transitional cell carcinoma (TCC) of the urothelium
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and are capable of all but physically strenuous activities.
Status   Open
Start Date   11/14/2016
Principal Name   Mary O’Keeffe, MD
Contact Name   Tara Simon, Research Nurse Coordinator
Fax   516-663-1822
Current Trial Type   Interventional
Phone   516-663-1822
Alternate Phone   516-663-8391