NCT03682068

Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer

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.

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,246 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open-label, controlled, multi-center, global Phase III study to determine the efficacy and safety of combining durvalumab ± tremelimumab with standard of care (SoC) chemotherapy (cisplatin + gemcitabine or carboplatin + gemcitabine doublet) followed by durvalumab monotherapy versus SoC alone as first-line chemotherapy in patients with histologically or cytologically documented, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra).

Conditions

• Unresectable Locally Advanced Urothelial Cancer
• Metastatic Urothelial Cancer

Interventions

Type	Name	Description
DRUG	Durvalumab	Durvalumab IV (intravenous infusion)
DRUG	Tremelimumab	Tremelimumab IV (intravenous infusion)
DRUG	Cisplatin + Gemcitabine	Cisplatin IV (intravenous)+ Gemcitabine IV(intravenous), as standard of care.
DRUG	Carboplatin + Gemcitabine	Carboplatin IV (intravenous)+ Gemcitabine IV(intravenous), as standard of care.

Timeline

• Start date: 2018-09-27
• Primary completion: 2026-04-29
• Completion: 2026-04-29
• First posted: 2018-09-24
• Last updated: 2026-02-03

Locations

222 sites across 22 countries: United States, Argentina, Australia, Brazil, Bulgaria, Canada, China, Czechia, Hungary, India, Israel, Italy, Japan, Philippines, Poland, Russia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Vietnam

Regulatory

• FDA-regulated drug study