Spots Global Cancer Trial Database for Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)
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Trial Identification
Brief Title: Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)
Official Title: 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
Study ID: NCT04003636
Conditions
Study Description
Brief Summary: 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).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Comprehensive Cancer Ctr ( Site 0016), Birmingham, Alabama, United States
University of California San Diego Moores Cancer Center ( Site 0008), La Jolla, California, United States
UCLA Hematology/Oncology - Santa Monica ( Site 0014), Los Angeles, California, United States
University of California - San Francisco ( Site 0030), San Francisco, California, United States
University of Colorado Hospital ( Site 0011), Aurora, Colorado, United States
Hartford Hospital ( Site 0057), Hartford, Connecticut, United States
Yale University ( Site 0053), New Haven, Connecticut, United States
Winship Cancer Institute of Emory University ( Site 0013), Atlanta, Georgia, United States
Northwest Georgia Oncology Centers PC ( Site 0045), Marietta, Georgia, United States
Decatur Memorial Hospital ( Site 0056), Decatur, Illinois, United States
Winthrop University Hospital ( Site 0059), Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0038), New York, New York, United States
Columbia University/Herbert Irving Cancer Center ( Site 0009), New York, New York, United States
University of Oklahoma- Stephenson Oklahoma Cancer Center ( Site 0055), Oklahoma City, Oklahoma, United States
OHSU Center for Health & Healing ( Site 0044), Portland, Oregon, United States
Charleston Oncology ( Site 0042), Charleston, South Carolina, United States
Saint Francis Health System ( Site 0051), Greenville, South Carolina, United States
Blue Ridge Cancer Care ( Site 0033), Roanoke, Virginia, United States
CEMIC ( Site 0581), Buenos Aires, Caba, Argentina
Fundacion Favaloro ( Site 0578), Ciudad de Buenos Aires, Caba, Argentina
Centro Medico San Roque ( Site 0579), San Miguel de Tucuman, Tucuman, Argentina
Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0580), Caba, , Argentina
Centro Oncologico Riojano Integral ( Site 0584), La Rioja, , Argentina
Liverpool Hospital ( Site 0707), Liverpool, New South Wales, Australia
Mid North Coast Cancer Institute ( Site 0708), Port Macquarie, New South Wales, Australia
Gallipoli Medical Research Foundation ( Site 0705), Brisbane, Queensland, Australia
Eastern Health ( Site 0704), Box Hill, Victoria, Australia
Western Health-Sunshine Hospital ( Site 0709), St Albans, Victoria, Australia
UZA University Hospital Antwerp ( Site 0202), Edegem, Antwerpen, Belgium
Saint-Luc UCL ( Site 0200), Brussels, Bruxelles-Capitale, Region De, Belgium
Erasme Hospital ( Site 0204), Bruxelles, Bruxelles-Capitale, Region De, Belgium
Grand Hopital de Charleroi ( Site 0206), Charleroi, Hainaut, Belgium
CHU de Liege ( Site 0201), Liège, Liege, Belgium
UZ Gent ( Site 0203), Gent, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 0205), Leuven, Vlaams-Brabant, Belgium
Oncobio Servicos de Saude SA ( Site 0604), Nova Lima, Minas Gerais, Brazil
Hospital de Caridade de Ijui ( Site 0602), Ijui, Rio Grande Do Sul, Brazil
Associacao Hospitalar Moinhos de Vento ( Site 0599), Porto Alegre, Rio Grande Do Sul, Brazil
Hospital de Clinicas de Porto Alegre ( Site 0610), Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Nossa Senhora da Conceicao ( Site 0601), Porto Alegre, Rio Grande Do Sul, Brazil
Instituto COI de Pesquisa Educacao e Gestao ( Site 0606), Rio de Janeiro, , Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0607), Sao Paulo, , Brazil
Hospital Paulistano - Amil Clinical Research ( Site 0603), Sao Paulo, , Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0609), Sao Paulo, , Brazil
A.C. Camargo Cancer Center ( Site 0600), Sao Paulo, , Brazil
Tom Baker Cancer Centre ( Site 0184), Calgary, Alberta, Canada
Cross Cancer Institute ( Site 0183), Edmonton, Alberta, Canada
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0182), Hamilton, Ontario, Canada
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0180), Montreal, Quebec, Canada
McGill University Health Centre ( Site 0179), Montreal, Quebec, Canada
Centro Investigación del Cáncer James Lind ( Site 0622), Temuco, Araucania, Chile
IC La Serena Research ( Site 0630), La Serena, Coquimbo, Chile
Servicios Medicos Urumed ( Site 0621), Rancagua, Lbtdr Gen Bernardo O Higgins, Chile
Fundacion Arturo Lopez Perez FALP ( Site 0623), Santiago, Region M. De Santiago, Chile
Sociedad Oncovida S.A. ( Site 0626), Santiago, Region M. De Santiago, Chile
Pontificia Universidad Catolica de Chile ( Site 0620), Santiago, Region M. De Santiago, Chile
Anhui Provincial Hospital ( Site 0140), Hefei, Anhui, China
Beijing Cancer Hospital ( Site 0138), Beijing, Beijing, China
Peking Union Medical College Hospital ( Site 0150), Beijing, Beijing, China
First Affiliated Hospital of The Third Military Medical University ( Site 0130), Chongqing, Chongqing, China
Fujian Provincial Cancer Hospital ( Site 0154), Fuzhou, Fujian, China
900 Hospital of the Joint ( Site 0137), Fuzhou, Fujian, China
Guangdong Provincial People s Hospital ( Site 0161), Guangzhou, Guangdong, China
The Third Xiangya Hospital of Central South University ( Site 0157), Changsha, Hainan, China
Harbin Medical University Cancer Hospital ( Site 0133), Harbin, Heilongjiang, China
Hunan Provincial People Hospital ( Site 0142), Changsha, Hunan, China
Hunan Cancer Hospital ( Site 0132), Changsha, Hunan, China
The 81st Hospital of PLA ( Site 0128), Nanjing, Jiangsu, China
The First Hospital of Jilin University ( Site 0131), Chanchun, Jilin, China
Zhongshan Hospital Fudan University ( Site 0129), Shanghai, Shanghai, China
Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0158), Shanghai, Shanghai, China
Fudan University Shanghai Cancer Center ( Site 0160), Shanghai, Shanghai, China
Tangdu Hospital ( Site 0146), XI An, Shanxi, China
The First Affiliated Hospital of Xi an Jiaotong University ( Site 0145), XI An, Shanxi, China
West China Hospital of Sichuan University ( Site 0147), Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital ( Site 0155), Tianjin, Tianjin, China
The First Affiliated Hospital Zhejiang University ( Site 0136), Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital ( Site 0134), Hangzhou, Zhejiang, China
CHU Bordeaux Haut-Leveque Centre Francois Magendie ( Site 0245), Pessac Cedex, Gironde, France
A.P.H. Paris, Hopital Beaujon ( Site 0247), Clichy, Hauts-de-Seine, France
CHU de Montpellier - Hopital Saint-Eloi ( Site 0248), Montpellier, Herault, France
Centre Eugene Marquis ( Site 0242), Rennes, Ille-et-Vilaine, France
CHU Clermont-Ferrand - Site Estaing ( Site 0249), Clermont-Ferrand, Puy-de-Dome, France
Gustave Roussy ( Site 0244), Villejuif, Val-de-Marne, France
Universitaetsklinikum Ulm ( Site 0267), Ulm, Baden-Wurttemberg, Germany
Klinikum der Ludwig - Maximilian Universitat Munchen ( Site 0264), Muenchen, Bayern, Germany
Krankenhaus Nordwest ( Site 0266), Frankfurt, Hessen, Germany
Medizinische Hochschule Hannover ( Site 0265), Hannover, Niedersachsen, Germany
Universitaetsklinikum Aachen AOER ( Site 0275), Aachen, Nordrhein-Westfalen, Germany
Universitaetsklinikum Essen ( Site 0273), Essen, Nordrhein-Westfalen, Germany
Universitaetsklinikum Koeln ( Site 0274), Koeln, Nordrhein-Westfalen, Germany
Universitaetsklinikum Magdeburg A.o.R. ( Site 0271), Magdeburg, Sachsen-Anhalt, Germany
Staedtisches Klinikum Dresden ( Site 0272), Dresden, Sachsen, Germany
Charite - Universtitatsmedizin Berlin CCM ( Site 0269), Berlin, , Germany
Universitaetsklinikum Hamburg-Eppendorf ( Site 0268), Hamburg, , Germany
Pamela Youde Nethersole Eastern Hospital ( Site 0857), Hong Kong, , Hong Kong
Prince of Wales Hospital ( Site 0855), Hong Kong, , Hong Kong
Princess Margaret Hospital. ( Site 0856), Hong Kong, , Hong Kong
Queen Mary Hospital ( Site 0851), Hong Kong, , Hong Kong
Queen Elizabeth Hospital. ( Site 0854), Kowloon, , Hong Kong
Cork University Hospital ( Site 0538), Cork, , Ireland
Bon Secours Hospital ( Site 0526), Cork, , Ireland
Tallaght University Hospital ( Site 0522), Dublin, , Ireland
St Vincents University Hospital ( Site 0521), Dublin, , Ireland
Rambam Medical Center ( Site 0308), Haifa, , Israel
Hadassah Ein Karem - Sharett Institute of Oncology ( Site 0309), Jerusalem, , Israel
Rabin Medical Center ( Site 0307), Petah Tikva, , Israel
Sourasky Medical Center ( Site 0306), Tel Aviv, , Israel
Universita Cattolica del Sacro Cuore - Policlinico Gemelli ( Site 0329), Rome, Abruzzo, Italy
Policlinico S. Orsola-Malpighi ( Site 0333), Bologna, , Italy
A.O. di Rilievo Nazionale e di alta Specializzazione Garibaldi ( Site 0330), Catania, , Italy
ASST Grande Ospedale Metropolitano Niguarda ( Site 0332), Milano, , Italy
Azienda Ospedaliero Universitaria Pisana ( Site 0326), Pisa, , Italy
Policlinico Universitario Campus Biomedico ( Site 0328), Roma, , Italy
Azienda Ospedaliera Universitaria di Verona ( Site 0334), Verona, , Italy
Aichi Cancer Center Hospital ( Site 0080), Nagoya, Aichi, Japan
National Cancer Center Hospital East ( Site 0081), Kashiwa, Chiba, Japan
Kobe City Medical Center General Hospital ( Site 0087), Kobe, Hyogo, Japan
Kagawa University Hospital ( Site 0086), Kita-gun, Kagawa, Japan
Kanagawa Cancer Center ( Site 0079), Yokohama, Kanagawa, Japan
Osaka University Hospital ( Site 0085), Suita, Osaka, Japan
Kyorin University Hospital ( Site 0077), Mitaka, Tokyo, Japan
National Hospital Organization Kyushu Cancer Center ( Site 0078), Fukuoka, , Japan
Kyoto University Hospital ( Site 0083), Kyoto, , Japan
Osaka International Cancer Institute ( Site 0084), Osaka, , Japan
The Cancer Institute Hospital of JFCR ( Site 0082), Tokyo, , Japan
Chonnam National University Hwasun Hospital ( Site 0837), Hwasun Gun, Jeonranamdo, Korea, Republic of
Seoul National University Bundang Hospital ( Site 0833), Seongnam-si, Kyonggi-do, Korea, Republic of
CHA Bundang Medical Center CHA University ( Site 0835), Seongnam, Kyonggi-do, Korea, Republic of
Ajou University Hospital, Clinical Research Center ( Site 0838), Suwon-si, Kyonggi-do, Korea, Republic of
Kyungpook National University Chilgok Hospital ( Site 0834), Daegu, Taegu-Kwangyokshi, Korea, Republic of
Chungnam National University Hospital ( Site 0840), Daejeon, Taejon-Kwangyokshi, Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 0836), Seoul, , Korea, Republic of
Asan Medical Center ( Site 0830), Seoul, , Korea, Republic of
Samsung Medical Center ( Site 0831), Seoul, , Korea, Republic of
The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0839), Seoul, , Korea, Republic of
Korea University Guro Hospital ( Site 0832), Seoul, , Korea, Republic of
Hospital Sultan Ismail ( Site 0772), Johor Bahru, Johor, Malaysia
University Malaya Medical Centre ( Site 0770), Lembah Pantai, Kuala Lumpur, Malaysia
Hospital Pulau Pinang ( Site 0773), Georgetown, Pulau Pinang, Malaysia
Institut Kanser Negara - National Cancer Institute ( Site 0767), Putrajaya, Wilayah Persekutuan Putrajaya, Malaysia
Hospital Kuala Lumpur ( Site 0768), Kuala Lumpur, , Malaysia
Pantai Hospital Kuala Lumpur ( Site 0771), Kuala Lumpur, , Malaysia
Maastricht University Medical Centre ( Site 0347), Maastricht, Limburg, Netherlands
AMC ( Site 0348), Amsterdam, Noord-Holland, Netherlands
Erasmus University Medical Center ( Site 0352), Rotterdam, Zuid-Holland, Netherlands
UMCG ( Site 0349), Groningen, , Netherlands
Universitair Medisch Centrum Utrecht ( Site 0351), Utrecht, , Netherlands
Auckland City Hospital ( Site 0725), Auckland, , New Zealand
Hospital Universitario General de Asturias ( Site 0434), Oviedo, Asturias, Spain
Hospital General Universitari Vall d Hebron ( Site 0432), Barcelona, , Spain
Hospital General Universitario Gregorio Maranon ( Site 0433), Madrid, , Spain
Hospital Universitario HM Sanchinarro ( Site 0435), Madrid, , Spain
Hospital Regional Universitario Carlos Haya ( Site 0431), Malaga, , Spain
Taipei Veterans General Hospital ( Site 0861), Taipei,, Taipei, Taiwan
Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0865), Kaohsiung, , Taiwan
China Medical University Hospital ( Site 0862), Taichung, , Taiwan
National Cheng Kung University Hospital ( Site 0864), Tainan, , Taiwan
National Taiwan University Hospital ( Site 0860), Taipei, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center ( Site 0863), Taipei, , Taiwan
Chang Gung Medical Foundation. Linkou ( Site 0853), Taoyuan, , Taiwan
King Chulalongkorn Memorial Hospital ( Site 0884), Bangkok, Krung Thep Maha Nakhon, Thailand
Ramathibodi Hospital. ( Site 0889), Bangkok, Krung Thep Maha Nakhon, Thailand
Siriraj Hospital ( Site 0888), Bangkok, Krung Thep Maha Nakhon, Thailand
Sunpasithiprasong Hospital ( Site 0883), Ubonratchathani, Ubon Ratchathani, Thailand
Maharaj Nakorn Chiang Mai Hospital ( Site 0887), Chiang Mai, , Thailand
Srinagarind Hospital ( Site 0885), Khon Kaen, , Thailand
Udon Thani Cancer Hospital ( Site 0886), Udon Thani, , Thailand
Inonu Universitesi Medical Fakultesi ( Site 0501), Malatya, Adana, Turkey
Baskent University Adana Training Hospital ( Site 0499), Adana, , Turkey
Hacettepe University Faculty of Medicine ( Site 0498), Ankara, , Turkey
Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0494), Ankara, , Turkey
Gazi Universitesi Tip Fakultesi ( Site 0496), Ankara, , Turkey
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0506), Istanbul, , Turkey
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0495), Istanbul, , Turkey
Izmir Medical Park Hospital Department of Medical Oncology ( Site 0502), Izmir, , Turkey
Erciyes Universitesi Tip Fakultesi ( Site 0500), Kayseri, , Turkey
Aberdeen Royal Infirmary ( Site 0529), Aberdeen, Aberdeen City, United Kingdom
Royal Free London NHS Foundation Trust ( Site 0520), London, London, City Of, United Kingdom
Royal Marsden Hospital ( Site 0536), London, London, City Of, United Kingdom
Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 0525), London, London, City Of, United Kingdom
Royal Marsden NHS Foundation Trust ( Site 0535), Sutton, Surrey, United Kingdom
Belfast City Hospital ( Site 0517), Belfast, , United Kingdom
University Hospital Coventry and Warwickshire NHS Trust ( Site 0518), Coventry, , United Kingdom
The Christie NHS Foundation Trust ( Site 0537), Manchester, , United Kingdom
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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