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Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer
Sponsor: AstraZeneca
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).
Official 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.
Key Details
Gender
All
Age Range
18 Years - 130 Years
Study Type
INTERVENTIONAL
Enrollment
1246
Start Date
2018-09-27
Completion Date
2027-06-01
Last Updated
2026-08-20
Healthy Volunteers
No
Interventions
Durvalumab
Durvalumab IV (intravenous infusion)
Tremelimumab
Tremelimumab IV (intravenous infusion)
Cisplatin + Gemcitabine
Cisplatin IV (intravenous)+ Gemcitabine IV(intravenous), as standard of care.
Carboplatin + Gemcitabine
Carboplatin IV (intravenous)+ Gemcitabine IV(intravenous), as standard of care.
Locations (222)
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Birmingham, Alabama, United States
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Bakersfield, California, United States
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Fullerton, California, United States
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Los Angeles, California, United States
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Salinas, California, United States
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Santa Barbara, California, United States
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Truckee, California, United States
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New Haven, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Orlando, Florida, United States
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Chicago, Illinois, United States
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Fort Wayne, Indiana, United States
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Kansas City, Kansas, United States
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Louisville, Kentucky, United States
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New Orleans, Louisiana, United States
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Grand Rapids, Michigan, United States
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Bozeman, Montana, United States
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New Hyde Park, New York, United States
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New York, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Germantown, Tennessee, United States
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Fort Worth, Texas, United States
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Ciudad de Buenos Aires, Argentina
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Ciudad de Buenos Aires, Argentina
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Ciudad de Buenos Aires, Argentina
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Ciudad de Buenos Aires, Argentina
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Rosario, Argentina
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Box Hill, Australia
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Elizabeth Vale, Australia
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Kogarah, Australia
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Macquarie University, Australia
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Murdoch, Australia
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Orange, Australia
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South Brisbane, Australia
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St Albans, Australia
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Curitiba, Brazil
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Fortaleza, Brazil
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Porto Alegre, Brazil
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Porto Alegre, Brazil
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Porto Alegre, Brazil
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Ribeirão Preto, Brazil
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Rio de Janeiro, Brazil
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Rio de Janeiro, Brazil
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Salvador, Brazil
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Santa Maria, Brazil
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São José do Rio Preto, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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Pleven, Bulgaria
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Plovdiv, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Hamilton, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Beijing, China
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Beijing, China
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Beijing, China
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Changchun, China
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Changsha, China
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Changsha, China
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Chongqing, China
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Chongqing, China
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Dalian, China
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Guangzhou, China
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Guangzhou, China
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Hangzhou, China
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Hangzhou, China
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Hangzhou, China
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Hangzhou, China
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Jinan, China
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Nanchang, China
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Nanjing, China
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Shanghai, China
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Shanghai, China
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Shenyang, China
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Suzhou, China
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Tianjin, China
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Tianjin, China
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Ürümqi, China
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Wuhan, China
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Xi'an, China
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Brno, Czechia
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Hradec Králové, Czechia
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Olomouc, Czechia
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Ostrava, Czechia
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Prague, Czechia
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Prague, Czechia
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Prague, Czechia
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Budapest, Hungary
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Budapest, Hungary
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Budapest, Hungary