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Trial ID CA209-901  |   NCT03036098

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

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Summary

  • Phase 3
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

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

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • Histological or cytological evidence of metastatic or surgically inoperable transitional cell cancer (TCC) of the urothelium involving the renal pelvis, ureter, bladder or urethra
    1. No prior systemic chemotherapy for metastatic or surgically inoperable urothelial cancer (UC)
      1. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
        1. Women and men must agree to follow specific methods of contraception, if applicable

          Exclusion Criteria

          Exclusion Criteria Icon
          :
          • Disease that is suitable for local therapy administered with curative intent
            1. 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
              1. 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
                Additional Information *

                Treatment Options

                Study Arms

                ASSIGNED INTERVENTION

                Study Arms

                Experimental: Arm A: Investigational immunotherapy

                ASSIGNED INTERVENTION
                • Biological: Nivolumab, Ipilimumab

                Study Arms

                Active Comparator: Arm B: Standard of care chemotherapy

                ASSIGNED INTERVENTION
                • Drug: Gemcitabine, Cisplatin, Carboplatin

                Study Arms

                Experimental: Arm C: Investigational immunotherapy

                ASSIGNED INTERVENTION
                • Biological: Nivolumab
                • Drug: Gemcitabine, Cisplatin

                Study Arms

                Active Comparator: Arm D: Standard of care chemotherapy

                ASSIGNED INTERVENTION
                • Drug: Gemcitabine, Cisplatin

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