A Phase III, Randomized, Open-label, Controlled, Multi-Center, Global Study of First-Line
MEDI4736 Monotherapy and MEDI4736 in Combination with Tremelimumab Versus Standard of Care
Chemotherapy in Patients with Stage IV Urothelial Bladder Cancer
This is a randomized, open-label, controlled, multi-center, global Phase III study to
determine the efficacy and safety of MEDI4736 monotherapy and MEDI4736 in combination with
tremelimumab versus SoC (cisplatin + gemcitabine or carboplatin + gemcitabine doublet)
first-line chemotherapy in treatment-naïve patients with histologically or cytologically
documented, unresectable, Stage IV transitional cell carcinoma (transitional cell and mixed
transitional/non-transitional cell histologies) of the urothelium. The patients will be
randomized in a 1:1:1 ratio to receive treatment with combination therapy, monotherapy, or
SoC (cisplatin + gemcitabine or carboplatin + gemcitabine, based on cisplatin eligibility).
Patients will be treated with MEDI4736 or MEDI4736 with tremelimumab for up to 12 months or
with SoC for up to 6 months. Patients will be followed for up to 2 years.