A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants With Advanced and/or Unresectable Biliary Tract Carcinoma
A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants With Advanced and/or Unresectable Biliary Tract Carcinoma
This is a study of pembrolizumab plus gemcitabine/cisplatin versus placebo plus gemcitabine/cisplatin as first-line therapy in participants with advanced and/or unresectable biliary tract carcinoma. The primary hypothesis is pembrolizumab plus gemcitabine/cisplatin is superior to placebo plus gemcitabine/cisplatin with respect to overall survival (OS).
Inclusion Criteria
Exclusion Criteria
Birmingham, Alabama 35294, United States
La Jolla, California 92093-0698, United States
New York, New York 10016, United States
New York, New York 10032, United States
Oklahoma City, Oklahoma 73104, United States
Ciudad de Buenos Aires, Buenos Aires F.D. C1093AAS, Argentina
CABA, C1264AAA, Argentina
Porto Alegre, Rio Grande do Sul 90035-001, Brazil
Chongqing, Chongqing Municipality 400038, China
Shanghai, Shanghai Municipality 200127, China
Tianjin, Tianjin Municipality 300060, China
Rome, Abruzzo 00168, Italy
Kita-gun, Kagawa-ken 761-0793, Japan
Lembah Pantai, Kuala Lumpur 59100, Malaysia
Hwasun Gun, Jeonranamdo 58128, South Korea
Daegu, Taegu-Kwangyokshi 41404, South Korea
Oviedo, Principality of Asturias 33011, Spain
Taipei,, Taipei 112, Taiwan
Ubonratchathani, Changwat Ubon Ratchathani 34000, Thailand
Malatya, Adana 44280, Turkey (Türkiye)
Istanbul, 34722, Turkey (Türkiye)
Izmir, 35520, Turkey (Türkiye)
London, London, City of W12 0HS, United Kingdom
Coventry, CV2 2DX, United Kingdom