NILE : A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line Durvalumab in Combination With Standard of Care Chemotherapy and Durvalumab in Combination With Tremelimumab and Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone in Patients With Unresectable Locally Advanced or Metastatic Urothelial Cancer

Trial Identifiers

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• NCT03682068
• D933SC00001

Scientific Title

A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line Durvalumab in Combination With Standard of Care Chemotherapy and Durvalumab in Combination With Tremelimumab and Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone in Patients With Unresectable Locally Advanced or Metastatic Urothelial Cancer

Commercial Sponsor

AstraZeneca

Summary

In this trial, participants will be randomised into one of three arms. In Experimental Arm 1, participants will receive Durvalumab (intravenously every three weeks)in combination with standard of care chemotherapy (SoC), followed by Durvalumab monotherapy every four weeks. In Experimental Arm 2, participants will receive Durvalumab and Tremelimumab (intravenously every three weeks) in combination with SoC, followed by Durvalumab monotherapy every four weeks. In this Arm, Tremelimumab will be administered over four cycles. In the Active Comparator Arm, participants will receive SoC (with either cisplatin + gemcitabine OR carboplatin + gemcitabine) every three weeks for six cycles.