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

Brief description of study

The purpose of the study is to determine the safety, tolerability, and effectiveness of the combination therapy of nivolumab plus ipilimumab administered every 3 weeks for up to four doses, followed by nivolumab monotherapy versus the standard of care in patients with previously untreated unresectable or metastatic urothelial cancer. Nivolumab and ipilimumab are types of immunotherapy that are being tested to see if they will allow the body’s immune system to work against tumor cells. Nivolumab is FDA and European Union approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed during a period of up to 1 year after first-line platinum-containing chemotherapy, however, ipilimumab is not specifically approved for bladder cancer so is considered experimental in this protocol.

Clinical Study Identifier: s18-00919
ClinicalTrials.gov Identifier: NCT03036098
Principal Investigator: Mary K O'Keeffe.

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