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.
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.
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).
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Key Exclusion Criteria:
Ciudad de Buenos Aires, 1280, Argentina
Ciudad de Buenos Aires, C1120AAT, Argentina
Ciudad de Buenos Aires, C1419AHL, Argentina
Ciudad de Buenos Aires, C1426ANZ, Argentina
Macquarie University, 2109, Australia
Hirosaki-shi, 036-8563, Japan
Kita-gun, 761-0793, Japan
Koshigaya-shi, 343-8555, Japan
Osakasayama-shi, 589-8511, Japan
Shinjuku-ku, 160-8582, Japan
Suita-shi, 565-0871, Japan
Mueang, 50200, Thailand