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

Official Title

A Phase III, Randomized, Open-Label, Controlled, Multi-Centre, 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.

Summary:

This is a randomized, open-label, controlled, multi-centre, 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).

Trial Description

Primary Outcome:

• Overall Survival (OS)

• Overall Survival (OS)
• Overall Survival at 24 months (OS24)
• Progression Free Survival (PFS)
• Alive and Progression Free Survival at 12 months (APF12)
• Objective Response Rate (ORR)
• Duration of Response (DoR)
• Disease Control Rate (DCR)
• Time from randomization to second (PFS2)
• To assess disease-related symptoms, physical functioning, and other Health-related quality of life

View this trial on ClinicalTrials.gov