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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

Recruiting

This is a randomized, open-label, Phase 3 study comparing combination therapy of nivolumab plus ipilimumab administered every 3 weeks for up to 4 doses, followed by nivolumab monotherapy administered every 4 weeks, versus the standard of care in participants with previously untreated unresectable or metastatic urothelial cancer. In addition, a substudy of treatment with nivolumab 360mg in combination with SoC every 3 weeks for up to 6 cycles followed by nivolumab monotherapy versus SoC alone will be evaluated in cisplatin-eligible participants with previously untreated unresectable or metastatic urothelial cancer.

I'm interested

This study is NOT accepting healthy volunteers

Urothelial Cancer

Patricia Beckmann - beckm001@umn.edu
Gautam Jha
Phase III
STUDY00001304
NCT03036098
See this study on ClinicalTrials.gov

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