Clinical trial NCT04003636: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Biliary Tract Carcinoma
Keywords: Programmed cell death 1 (PD-1)
Pembrolizumab
Cholangiocarcinoma
Gallbladder cancer
Checkpoint inhibitor
Immunotherapy
Biliary
Keytruda
Bile Duct Cancer
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2019-07-01
Enrollment: 1069
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria

* Has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer)
* Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as determined by the site investigator
* Participants with a history of hepatitis B or hepatitis C can be enrolled if they meet study criteria
* Is able to provide archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion
* Has a life expectancy of greater than 3 months
* Has adequate organ function

Exclusion Criteria

* Has had previous systemic therapy for advanced (metastatic) or unresectable (locally advanced) biliary tract cancer (intra-or extra hepatic cholangiocarcinoma or gallbladder cancer)
* Has ampullary cancer
* Has small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology and/or mucinous cystic neoplasms
* Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti- programmed cell death ligand 1 or 2 (anti-PD-L1, anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], OX-40, CD137)
* Has a known history of, or any evidence of, central nervous system (CNS) metastases and/or carcinomatous meningitis, as assessed by local site investigator
* Has had an allogenic tissue/solid organ transplant

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 38 months
Secondary outcomes:
measure: Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (BICR)
timeFrame: Up to approximately 26 months
measure: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
timeFrame: Up to approximately 26 months
measure: Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
timeFrame: Up to approximately 38 months
measure: Number of Participants Who Experience One or More Adverse Events (AE)
timeFrame: Up to approximately 38 months
measure: Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)
timeFrame: Up to approximately 38 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Comprehensive Cancer Ctr ( Site 0016)
state: Alabama
city: La Jolla
country: United States
facility: University of California San Diego Moores Cancer Center ( Site 0008)
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology - Santa Monica ( Site 0014)
state: California
city: San Francisco
country: United States
facility: University of California - San Francisco ( Site 0030)
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital ( Site 0011)
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital ( Site 0057)
state: Connecticut
city: New Haven
country: United States
facility: Yale University ( Site 0053)
state: Connecticut
city: Atlanta
country: United States
facility: Winship Cancer Institute of Emory University ( Site 0013)
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers PC ( Site 0045)
state: Georgia
city: Decatur
country: United States
facility: Decatur Memorial Hospital ( Site 0056)
state: Illinois
city: Mineola
country: United States
facility: Winthrop University Hospital ( Site 0059)
state: New York
city: New York
country: United States
facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0038)
state: New York
city: New York
country: United States
facility: Columbia University/Herbert Irving Cancer Center ( Site 0009)
state: New York
city: Oklahoma City
country: United States
facility: University of Oklahoma- Stephenson Oklahoma Cancer Center ( Site 0055)
state: Oklahoma
city: Portland
country: United States
facility: OHSU Center for Health & Healing ( Site 0044)
state: Oregon
city: Charleston
country: United States
facility: Charleston Oncology ( Site 0042)
state: South Carolina
city: Greenville
country: United States
facility: Saint Francis Health System ( Site 0051)
state: South Carolina
city: Roanoke
country: United States
facility: Blue Ridge Cancer Care ( Site 0033)
state: Virginia
city: Buenos Aires
country: Argentina
facility: CEMIC ( Site 0581)
state: Caba
city: Ciudad de Buenos Aires
country: Argentina
facility: Fundacion Favaloro ( Site 0578)
state: Caba
city: San Miguel de Tucuman
country: Argentina
facility: Centro Medico San Roque ( Site 0579)
state: Tucuman
city: Caba
country: Argentina
facility: Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0580)
city: La Rioja
country: Argentina
facility: Centro Oncologico Riojano Integral ( Site 0584)
city: Liverpool
country: Australia
facility: Liverpool Hospital ( Site 0707)
state: New South Wales
city: Port Macquarie
country: Australia
facility: Mid North Coast Cancer Institute ( Site 0708)
state: New South Wales
city: Brisbane
country: Australia
facility: Gallipoli Medical Research Foundation ( Site 0705)
state: Queensland
city: Box Hill
country: Australia
facility: Eastern Health ( Site 0704)
state: Victoria
city: St Albans
country: Australia
facility: Western Health-Sunshine Hospital ( Site 0709)
state: Victoria
city: Edegem
country: Belgium
facility: UZA University Hospital Antwerp ( Site 0202)
state: Antwerpen
city: Brussels
country: Belgium
facility: Saint-Luc UCL ( Site 0200)
state: Bruxelles-Capitale, Region De
city: Bruxelles
country: Belgium
facility: Erasme Hospital ( Site 0204)
state: Bruxelles-Capitale, Region De
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi ( Site 0206)
state: Hainaut
city: Liège
country: Belgium
facility: CHU de Liege ( Site 0201)
state: Liege
city: Gent
country: Belgium
facility: UZ Gent ( Site 0203)
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven ( Site 0205)
state: Vlaams-Brabant
city: Nova Lima
country: Brazil
facility: Oncobio Servicos de Saude SA ( Site 0604)
state: Minas Gerais
city: Ijui
country: Brazil
facility: Hospital de Caridade de Ijui ( Site 0602)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Associacao Hospitalar Moinhos de Vento ( Site 0599)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre ( Site 0610)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao ( Site 0601)
state: Rio Grande Do Sul
city: Rio de Janeiro
country: Brazil
facility: Instituto COI de Pesquisa Educacao e Gestao ( Site 0606)
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0607)
city: Sao Paulo
country: Brazil
facility: Hospital Paulistano - Amil Clinical Research ( Site 0603)
city: Sao Paulo
country: Brazil
facility: Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0609)
city: Sao Paulo
country: Brazil
facility: A.C. Camargo Cancer Center ( Site 0600)
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre ( Site 0184)
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute ( Site 0183)
state: Alberta
city: Hamilton
country: Canada
facility: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0182)
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0180)
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre ( Site 0179)
state: Quebec
city: Temuco
country: Chile
facility: Centro Investigación del Cáncer James Lind ( Site 0622)
state: Araucania
city: La Serena
country: Chile
facility: IC La Serena Research ( Site 0630)
state: Coquimbo
city: Rancagua
country: Chile
facility: Servicios Medicos Urumed ( Site 0621)
state: Lbtdr Gen Bernardo O Higgins
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez FALP ( Site 0623)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Sociedad Oncovida S.A. ( Site 0626)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile ( Site 0620)
state: Region M. De Santiago
city: Hefei
country: China
facility: Anhui Provincial Hospital ( Site 0140)
state: Anhui
city: Beijing
country: China
facility: Beijing Cancer Hospital ( Site 0138)
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital ( Site 0150)
state: Beijing
city: Chongqing
country: China
facility: First Affiliated Hospital of The Third Military Medical University ( Site 0130)
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital ( Site 0154)
state: Fujian
city: Fuzhou
country: China
facility: 900 Hospital of the Joint ( Site 0137)
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Provincial People s Hospital ( Site 0161)
state: Guangdong
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University ( Site 0157)
state: Hainan
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital ( Site 0133)
state: Heilongjiang
city: Changsha
country: China
facility: Hunan Provincial People Hospital ( Site 0142)
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 0132)
state: Hunan
city: Nanjing
country: China
facility: The 81st Hospital of PLA ( Site 0128)
state: Jiangsu
city: Chanchun
country: China
facility: The First Hospital of Jilin University ( Site 0131)
state: Jilin
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University ( Site 0129)
state: Shanghai
city: Shanghai
country: China
facility: Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0158)
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center ( Site 0160)
state: Shanghai
city: XI An
country: China
facility: Tangdu Hospital ( Site 0146)
state: Shanxi
city: XI An
country: China
facility: The First Affiliated Hospital of Xi an Jiaotong University ( Site 0145)
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University ( Site 0147)
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital ( Site 0155)
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital Zhejiang University ( Site 0136)
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital ( Site 0134)
state: Zhejiang
city: Pessac Cedex
country: France
facility: CHU Bordeaux Haut-Leveque Centre Francois Magendie ( Site 0245)
state: Gironde
city: Clichy
country: France
facility: A.P.H. Paris, Hopital Beaujon ( Site 0247)
state: Hauts-de-Seine
city: Montpellier
country: France
facility: CHU de Montpellier - Hopital Saint-Eloi ( Site 0248)
state: Herault
city: Rennes
country: France
facility: Centre Eugene Marquis ( Site 0242)
state: Ille-et-Vilaine
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand - Site Estaing ( Site 0249)
state: Puy-de-Dome
city: Villejuif
country: France
facility: Gustave Roussy ( Site 0244)
state: Val-de-Marne
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm ( Site 0267)
state: Baden-Wurttemberg
city: Muenchen
country: Germany
facility: Klinikum der Ludwig - Maximilian Universitat Munchen ( Site 0264)
state: Bayern
city: Frankfurt
country: Germany
facility: Krankenhaus Nordwest ( Site 0266)
state: Hessen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover ( Site 0265)
state: Niedersachsen
city: Aachen
country: Germany
facility: Universitaetsklinikum Aachen AOER ( Site 0275)
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Universitaetsklinikum Essen ( Site 0273)
state: Nordrhein-Westfalen
city: Koeln
country: Germany
facility: Universitaetsklinikum Koeln ( Site 0274)
state: Nordrhein-Westfalen
city: Magdeburg
country: Germany
facility: Universitaetsklinikum Magdeburg A.o.R. ( Site 0271)
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: Staedtisches Klinikum Dresden ( Site 0272)
state: Sachsen
city: Berlin
country: Germany
facility: Charite - Universtitatsmedizin Berlin CCM ( Site 0269)
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf ( Site 0268)
city: Hong Kong
country: Hong Kong
facility: Pamela Youde Nethersole Eastern Hospital ( Site 0857)
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital ( Site 0855)
city: Hong Kong
country: Hong Kong
facility: Princess Margaret Hospital. ( Site 0856)
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital ( Site 0851)
city: Kowloon
country: Hong Kong
facility: Queen Elizabeth Hospital. ( Site 0854)
city: Cork
country: Ireland
facility: Cork University Hospital ( Site 0538)
city: Cork
country: Ireland
facility: Bon Secours Hospital ( Site 0526)
city: Dublin
country: Ireland
facility: Tallaght University Hospital ( Site 0522)
city: Dublin
country: Ireland
facility: St Vincents University Hospital ( Site 0521)
city: Haifa
country: Israel
facility: Rambam Medical Center ( Site 0308)
city: Jerusalem
country: Israel
facility: Hadassah Ein Karem - Sharett Institute of Oncology ( Site 0309)
city: Petah Tikva
country: Israel
facility: Rabin Medical Center ( Site 0307)
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center ( Site 0306)
city: Rome
country: Italy
facility: Universita Cattolica del Sacro Cuore - Policlinico Gemelli ( Site 0329)
state: Abruzzo
city: Bologna
country: Italy
facility: Policlinico S. Orsola-Malpighi ( Site 0333)
city: Catania
country: Italy
facility: A.O. di Rilievo Nazionale e di alta Specializzazione Garibaldi ( Site 0330)
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda ( Site 0332)
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana ( Site 0326)
city: Roma
country: Italy
facility: Policlinico Universitario Campus Biomedico ( Site 0328)
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria di Verona ( Site 0334)
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital ( Site 0080)
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 0081)
state: Chiba
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital ( Site 0087)
state: Hyogo
city: Kita-gun
country: Japan
facility: Kagawa University Hospital ( Site 0086)
state: Kagawa
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center ( Site 0079)
state: Kanagawa
city: Suita
country: Japan
facility: Osaka University Hospital ( Site 0085)
state: Osaka
city: Mitaka
country: Japan
facility: Kyorin University Hospital ( Site 0077)
state: Tokyo
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center ( Site 0078)
city: Kyoto
country: Japan
facility: Kyoto University Hospital ( Site 0083)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 0084)
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR ( Site 0082)
city: Hwasun Gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital ( Site 0837)
state: Jeonranamdo
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital ( Site 0833)
state: Kyonggi-do
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center CHA University ( Site 0835)
state: Kyonggi-do
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital, Clinical Research Center ( Site 0838)
state: Kyonggi-do
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital ( Site 0834)
state: Taegu-Kwangyokshi
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital ( Site 0840)
state: Taejon-Kwangyokshi
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System ( Site 0836)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 0830)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 0831)
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0839)
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital ( Site 0832)
city: Johor Bahru
country: Malaysia
facility: Hospital Sultan Ismail ( Site 0772)
state: Johor
city: Lembah Pantai
country: Malaysia
facility: University Malaya Medical Centre ( Site 0770)
state: Kuala Lumpur
city: Georgetown
country: Malaysia
facility: Hospital Pulau Pinang ( Site 0773)
state: Pulau Pinang
city: Putrajaya
country: Malaysia
facility: Institut Kanser Negara - National Cancer Institute ( Site 0767)
state: Wilayah Persekutuan Putrajaya
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur ( Site 0768)
city: Kuala Lumpur
country: Malaysia
facility: Pantai Hospital Kuala Lumpur ( Site 0771)
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre ( Site 0347)
state: Limburg
city: Amsterdam
country: Netherlands
facility: AMC ( Site 0348)
state: Noord-Holland
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center ( Site 0352)
state: Zuid-Holland
city: Groningen
country: Netherlands
facility: UMCG ( Site 0349)
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht ( Site 0351)
city: Auckland
country: New Zealand
facility: Auckland City Hospital ( Site 0725)
city: Oviedo
country: Spain
facility: Hospital Universitario General de Asturias ( Site 0434)
state: Asturias
city: Barcelona
country: Spain
facility: Hospital General Universitari Vall d Hebron ( Site 0432)
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon ( Site 0433)
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro ( Site 0435)
city: Malaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya ( Site 0431)
city: Taipei,
country: Taiwan
facility: Taipei Veterans General Hospital ( Site 0861)
state: Taipei
city: Kaohsiung
country: Taiwan
facility: Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0865)
city: Taichung
country: Taiwan
facility: China Medical University Hospital ( Site 0862)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 0864)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 0860)
city: Taipei
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center ( Site 0863)
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation. Linkou ( Site 0853)
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital ( Site 0884)
state: Krung Thep Maha Nakhon
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital. ( Site 0889)
state: Krung Thep Maha Nakhon
city: Bangkok
country: Thailand
facility: Siriraj Hospital ( Site 0888)
state: Krung Thep Maha Nakhon
city: Ubonratchathani
country: Thailand
facility: Sunpasithiprasong Hospital ( Site 0883)
state: Ubon Ratchathani
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital ( Site 0887)
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital ( Site 0885)
city: Udon Thani
country: Thailand
facility: Udon Thani Cancer Hospital ( Site 0886)
city: Malatya
country: Turkey
facility: Inonu Universitesi Medical Fakultesi ( Site 0501)
state: Adana
city: Adana
country: Turkey
facility: Baskent University Adana Training Hospital ( Site 0499)
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Medicine ( Site 0498)
city: Ankara
country: Turkey
facility: Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0494)
city: Ankara
country: Turkey
facility: Gazi Universitesi Tip Fakultesi ( Site 0496)
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0506)
city: Istanbul
country: Turkey
facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0495)
city: Izmir
country: Turkey
facility: Izmir Medical Park Hospital Department of Medical Oncology ( Site 0502)
city: Kayseri
country: Turkey
facility: Erciyes Universitesi Tip Fakultesi ( Site 0500)
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary ( Site 0529)
state: Aberdeen City
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust ( Site 0520)
state: London, City Of
city: London
country: United Kingdom
facility: Royal Marsden Hospital ( Site 0536)
state: London, City Of
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 0525)
state: London, City Of
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust ( Site 0535)
state: Surrey
city: Belfast
country: United Kingdom
facility: Belfast City Hospital ( Site 0517)
city: Coventry
country: United Kingdom
facility: University Hospital Coventry and Warwickshire NHS Trust ( Site 0518)
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust ( Site 0537)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Kelley RK, Ueno M, Yoo C, Finn RS, Furuse J, Ren Z, Yau T, Klumpen HJ, Chan SL, Ozaka M, Verslype C, Bouattour M, Park JO, Barajas O, Pelzer U, Valle JW, Yu L, Malhotra U, Siegel AB, Edeline J, Vogel A; KEYNOTE-966 Investigators. Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 Jun 3;401(10391):1853-1865. doi: 10.1016/S0140-6736(23)00727-4. Epub 2023 Apr 16.