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Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)
Sponsor: AstraZeneca
Summary
Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1).
Official title: A Phase III Randomized, Double-Blind Placebo Controlled, Multi-Regional, International Study of Durvalumab in Combination With Gemcitabine Plus Cisplatin Versus Placebo in Combination With Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers
Key Details
Gender
All
Age Range
18 Years - 130 Years
Study Type
INTERVENTIONAL
Enrollment
810
Start Date
2019-04-16
Completion Date
2027-05-16
Last Updated
2026-03-19
Healthy Volunteers
No
Conditions
Interventions
Durvalumab
IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
Placebo
IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
Locations (126)
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Los Angeles, California, United States
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Orange, California, United States
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Washington D.C., District of Columbia, United States
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Fort Myers, Florida, United States
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St. Petersburg, Florida, United States
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Westwood, Kansas, United States
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Louisville, Kentucky, United States
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Burlington, Massachusetts, United States
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St Louis, Missouri, United States
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Chapel Hill, North Carolina, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Chattanooga, Tennessee, United States
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Nashville, Tennessee, United States
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Seattle, Washington, United States
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Buenos Aires, Argentina
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CABA, Argentina
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CABA, 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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San Salvador de Jujuy, Argentina
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Burgas, 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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Santiago, Chile
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Temuco, Chile
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Baoding, China
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Beijing, China
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Beijing, China
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Bengbu, China
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Chongqing, China
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Foshan, China
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Guangzhou, China
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Hangzhou, China
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Hangzhou, China
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Harbin, China
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Hefei, China
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Hefei, China
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Jinan, China
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Nanchang, China
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Nanjing, China
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Shandong, China
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Shanghai, China
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Shenyang, China
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Suzhou, China
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Xi'an, China
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Zhengzhou, China
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Zhuhai, China
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Clichy, France
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Dijon, France
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Montpellier, France
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Nice, France
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Paris, France
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Pessac, France
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Poitiers, France
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Hong Kong, Hong Kong
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Hong Kong, Hong Kong
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Hong Kong, Hong Kong
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Kowloon, Hong Kong
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Gūrgaon, India
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Kolkata, India
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Mumbai, India
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New Delhi, India
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Faenza, Italy
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Florence, Italy
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Milan, Italy
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Naples, Italy
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Roma, Italy
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Verona, Italy
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Chūōku, Japan
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Kashiwa, Japan
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Kitaadachi-gun, Japan
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Mitaka-shi, Japan
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Osaka, Japan
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Suita-shi, Japan
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Wakayama, Japan
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Yokohama, Japan
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Gdansk, Poland
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Lodz, Poland
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Olsztyn, Poland
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Poznan, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Barnaul, Russia
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Kostroma, Russia
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Moscow, Russia
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Moscow, Russia
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Moscow, Russia
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Omsk, Russia
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Saint Petersburg, Russia
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Saint Petersburg, Russia
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Seongnam-si, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Chiayi City, Taiwan
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Kaohsiung City, Taiwan
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Kaohsiung City, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Bangkok, Thailand
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Bangkok, Thailand
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Hat Yai, Thailand
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Khon Kaen, Thailand
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Muang, Thailand
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Si Sa Ket, Thailand
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Ankara, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Mersin, Turkey (Türkiye)
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Bristol, United Kingdom
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Cambridge, United Kingdom
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London, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Oxford, United Kingdom
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Romford, United Kingdom
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Sheffield, United Kingdom