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)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,069

Participants

Timeline

Start Date

September 24, 2019

Primary Completion Date

December 15, 2022

Study Completion Date

April 1, 2025

Conditions
Biliary Tract Carcinoma
Interventions
BIOLOGICAL

Pembrolizumab

Pembrolizumab by intravenous (IV) infusion

DRUG

Gemcitabine

Gemcitabine by IV infusion

DRUG

Cisplatin

Cisplatin by IV infusion

DRUG

Placebo

Placebo to pembrolizumab

Trial Locations (185)

112

Taipei Veterans General Hospital ( Site 0861), Taipei,

Koo Foundation Sun Yat-Sen Cancer Center ( Site 0863), Taipei

333

Chang Gung Medical Foundation. Linkou ( Site 0853), Taoyuan District

704

National Cheng Kung University Hospital ( Site 0864), Tainan City

833

Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0865), Kaohsiung City

1023

Auckland City Hospital ( Site 0725), Auckland

1070

Erasme Hospital ( Site 0204), Brussels

1200

Saint-Luc UCL ( Site 0200), Brussels

2170

Liverpool Hospital ( Site 0707), Liverpool

2444

Mid North Coast Cancer Institute ( Site 0708), Port Macquarie

2650

UZA University Hospital Antwerp ( Site 0202), Edegem

3000

UZ Leuven ( Site 0205), Leuven

3021

Western Health-Sunshine Hospital ( Site 0709), St Albans

3128

Eastern Health ( Site 0704), Box Hill

4000

CHU de Liege ( Site 0201), Liège

4120

Gallipoli Medical Research Foundation ( Site 0705), Brisbane

6000

Grand Hopital de Charleroi ( Site 0206), Charleroi

9000

UZ Gent ( Site 0203), Ghent

10016

Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0038), New York

10032

Columbia University/Herbert Irving Cancer Center ( Site 0009), New York

10048

National Taiwan University Hospital ( Site 0860), Taipei

10117

Charite - Universtitatsmedizin Berlin CCM ( Site 0269), Berlin

10330

King Chulalongkorn Memorial Hospital ( Site 0884), Bangkok

10400

Ramathibodi Hospital. ( Site 0889), Bangkok

10700

Siriraj Hospital ( Site 0888), Bangkok

10990

Hospital Pulau Pinang ( Site 0773), George Town

11501

Winthrop University Hospital ( Site 0059), Mineola

13496

CHA Bundang Medical Center CHA University ( Site 0835), Seongnam

13605

Seoul National University Bundang Hospital ( Site 0833), Seongnam-si

16499

Ajou University Hospital, Clinical Research Center ( Site 0838), Suwon

20162

ASST Grande Ospedale Metropolitano Niguarda ( Site 0332), Milan

20246

Universitaetsklinikum Hamburg-Eppendorf ( Site 0268), Hamburg

24014

Blue Ridge Cancer Care ( Site 0033), Roanoke

28009

Hospital General Universitario Gregorio Maranon ( Site 0433), Madrid

28050

Hospital Universitario HM Sanchinarro ( Site 0435), Madrid

29010

Hospital Regional Universitario Carlos Haya ( Site 0431), Málaga

29414

Charleston Oncology ( Site 0042), Charleston

29607

Saint Francis Health System ( Site 0051), Greenville

30060

Northwest Georgia Oncology Centers PC ( Site 0045), Marietta

30625

Medizinische Hochschule Hannover ( Site 0265), Hanover

33011

Hospital Universitario General de Asturias ( Site 0434), Oviedo

33604

CHU Bordeaux Haut-Leveque Centre Francois Magendie ( Site 0245), Pessac

34000

Sunpasithiprasong Hospital ( Site 0883), Ubonratchathani

34098

Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0506), Istanbul

34295

CHU de Montpellier - Hopital Saint-Eloi ( Site 0248), Montpellier

34722

Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0495), Istanbul

35015

Chungnam National University Hospital ( Site 0840), Daejeon

35042

Centre Eugene Marquis ( Site 0242), Rennes

35294

University of Alabama at Birmingham Comprehensive Cancer Ctr ( Site 0016), Birmingham

35520

Izmir Medical Park Hospital Department of Medical Oncology ( Site 0502), Izmir

37134

Azienda Ospedaliera Universitaria di Verona ( Site 0334), Verona

38039

Erciyes Universitesi Tip Fakultesi ( Site 0500), Kayseri

39120

Universitaetsklinikum Magdeburg A.o.R. ( Site 0271), Magdeburg

40002

Srinagarind Hospital ( Site 0885), Khon Kaen

40138

Policlinico S. Orsola-Malpighi ( Site 0333), Bologna

40447

China Medical University Hospital ( Site 0862), Taichung

41330

Udon Thani Cancer Hospital ( Site 0886), Udon Thani

41404

Kyungpook National University Chilgok Hospital ( Site 0834), Daegu

44280

Inonu Universitesi Medical Fakultesi ( Site 0501), Malatya

45147

Universitaetsklinikum Essen ( Site 0273), Essen

50200

Maharaj Nakorn Chiang Mai Hospital ( Site 0887), Chiang Mai

50586

Hospital Kuala Lumpur ( Site 0768), Kuala Lumpur

50937

Universitaetsklinikum Koeln ( Site 0274), Cologne

52074

Universitaetsklinikum Aachen AOER ( Site 0275), Aachen

56127

Azienda Ospedaliero Universitaria Pisana ( Site 0326), Pisa

58128

Chonnam National University Hwasun Hospital ( Site 0837), Hwasun Gun

59100

University Malaya Medical Centre ( Site 0770), Lembah Pantai

Pantai Hospital Kuala Lumpur ( Site 0771), Kuala Lumpur

60488

Krankenhaus Nordwest ( Site 0266), Frankfurt am Main

62250

Institut Kanser Negara - National Cancer Institute ( Site 0767), Putrajaya

62526

Decatur Memorial Hospital ( Site 0056), Decatur

63003

CHU Clermont-Ferrand - Site Estaing ( Site 0249), Clermont-Ferrand

73104

University of Oklahoma- Stephenson Oklahoma Cancer Center ( Site 0055), Oklahoma City

80045

University of Colorado Hospital ( Site 0011), Aurora

81100

Hospital Sultan Ismail ( Site 0772), Johor Bahru

81377

Klinikum der Ludwig - Maximilian Universitat Munchen ( Site 0264), Munich

89081

Universitaetsklinikum Ulm ( Site 0267), Ulm

90404

UCLA Hematology/Oncology - Santa Monica ( Site 0014), Los Angeles

92110

A.P.H. Paris, Hopital Beaujon ( Site 0247), Clichy

94158

University of California - San Francisco ( Site 0030), San Francisco

94805

Gustave Roussy ( Site 0244), Villejuif

95124

A.O. di Rilievo Nazionale e di alta Specializzazione Garibaldi ( Site 0330), Catania

97239

OHSU Center for Health & Healing ( Site 0044), Portland

100036

Beijing Cancer Hospital ( Site 0138), Beijing

100730

Peking Union Medical College Hospital ( Site 0150), Beijing

130021

The First Hospital of Jilin University ( Site 0131), Changchun

200032

Zhongshan Hospital Fudan University ( Site 0129), Shanghai

200127

Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0158), Shanghai

201315

Fudan University Shanghai Cancer Center ( Site 0160), Shanghai

210031

The 81st Hospital of PLA ( Site 0128), Nanjing

230001

Anhui Provincial Hospital ( Site 0140), Hefei

300060

Tianjin Medical University Cancer Institute & Hospital ( Site 0155), Tianjin

310003

The First Affiliated Hospital Zhejiang University ( Site 0136), Hangzhou

310022

Zhejiang Cancer Hospital ( Site 0134), Hangzhou

350014

Fujian Provincial Cancer Hospital ( Site 0154), Fuzhou

350025

900 Hospital of the Joint ( Site 0137), Fuzhou

400038

First Affiliated Hospital of The Third Military Medical University ( Site 0130), Chongqing

410005

Hunan Provincial People Hospital ( Site 0142), Changsha

410013

The Third Xiangya Hospital of Central South University ( Site 0157), Changsha

Hunan Cancer Hospital ( Site 0132), Changsha

510080

Guangdong Provincial People s Hospital ( Site 0161), Guangzhou

610000

Harbin Medical University Cancer Hospital ( Site 0133), Harbin

610041

West China Hospital of Sichuan University ( Site 0147), Chengdu

710038

Tangdu Hospital ( Site 0146), Xi’an

710048

The First Affiliated Hospital of Xi an Jiaotong University ( Site 0145), Xi’an

1720430

IC La Serena Research ( Site 0630), La Serena

2852424

Servicios Medicos Urumed ( Site 0621), Rancagua

3109601

Rambam Medical Center ( Site 0308), Haifa

4780000

Centro Investigación del Cáncer James Lind ( Site 0622), Temuco

4941492

Rabin Medical Center ( Site 0307), Petah Tikva

6423906

Sourasky Medical Center ( Site 0306), Tel Aviv

7500921

Fundacion Arturo Lopez Perez FALP ( Site 0623), Santiago

7510032

Sociedad Oncovida S.A. ( Site 0626), Santiago

8330032

Pontificia Universidad Catolica de Chile ( Site 0620), Santiago

9112001

Hadassah Ein Karem - Sharett Institute of Oncology ( Site 0309), Jerusalem

92093-0698

University of California San Diego Moores Cancer Center ( Site 0008), La Jolla

06102

Hartford Hospital ( Site 0057), Hartford

06510

Yale University ( Site 0053), New Haven

30322-1013

Winship Cancer Institute of Emory University ( Site 0013), Atlanta

C1431FWO

CEMIC ( Site 0581), Buenos Aires

C1093AAS

Fundacion Favaloro ( Site 0578), Ciudad de Buenos Aires

T4000IAK

Centro Medico San Roque ( Site 0579), San Miguel de Tucumán

C1264AAA

Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0580), CABA

F5300COE

Centro Oncologico Riojano Integral ( Site 0584), La Rioja

34000-000

Oncobio Servicos de Saude SA ( Site 0604), Nova Lima

98700-000

Hospital de Caridade de Ijui ( Site 0602), Ijuí

90035-001

Associacao Hospitalar Moinhos de Vento ( Site 0599), Porto Alegre

90035-903

Hospital de Clinicas de Porto Alegre ( Site 0610), Porto Alegre

91350-200

Hospital Nossa Senhora da Conceicao ( Site 0601), Porto Alegre

22793-080

Instituto COI de Pesquisa Educacao e Gestao ( Site 0606), Rio de Janeiro

01246-000

Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0607), São Paulo

01321-001

Hospital Paulistano - Amil Clinical Research ( Site 0603), São Paulo

Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0609), São Paulo

01509-900

A.C. Camargo Cancer Center ( Site 0600), São Paulo

T2N 4N2

Tom Baker Cancer Centre ( Site 0184), Calgary

T6G 1Z2

Cross Cancer Institute ( Site 0183), Edmonton

L8V5C2

Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0182), Hamilton

H2X 3E4

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0180), Montreal

H4A 3J1

McGill University Health Centre ( Site 0179), Montreal

01067

Staedtisches Klinikum Dresden ( Site 0272), Dresden

Unknown

Pamela Youde Nethersole Eastern Hospital ( Site 0857), Hong Kong

Prince of Wales Hospital ( Site 0855), Hong Kong

Princess Margaret Hospital. ( Site 0856), Hong Kong

Queen Mary Hospital ( Site 0851), Hong Kong

Queen Elizabeth Hospital. ( Site 0854), Kowloon

T12 DC4A

Cork University Hospital ( Site 0538), Cork

T12 DV56

Bon Secours Hospital ( Site 0526), Cork

D24 NROA

Tallaght University Hospital ( Site 0522), Dublin

DO4 YN63

St Vincents University Hospital ( Site 0521), Dublin

00168

Universita Cattolica del Sacro Cuore - Policlinico Gemelli ( Site 0329), Rome

00128

Policlinico Universitario Campus Biomedico ( Site 0328), Roma

464-8681

Aichi Cancer Center Hospital ( Site 0080), Nagoya

277-8577

National Cancer Center Hospital East ( Site 0081), Kashiwa

650-0047

Kobe City Medical Center General Hospital ( Site 0087), Kobe

761-0793

Kagawa University Hospital ( Site 0086), Kita-gun

241-8515

Kanagawa Cancer Center ( Site 0079), Yokohama

565-0871

Osaka University Hospital ( Site 0085), Suita

181-8611

Kyorin University Hospital ( Site 0077), Mitaka

811-1395

National Hospital Organization Kyushu Cancer Center ( Site 0078), Fukuoka

606-8507

Kyoto University Hospital ( Site 0083), Kyoto

541-8567

Osaka International Cancer Institute ( Site 0084), Osaka

135-8550

The Cancer Institute Hospital of JFCR ( Site 0082), Tokyo

6229 HX

Maastricht University Medical Centre ( Site 0347), Maastricht

1105 AZ

AMC ( Site 0348), Amsterdam

3015 GD

Erasmus University Medical Center ( Site 0352), Rotterdam

9713 GZ

UMCG ( Site 0349), Groningen

3584 CX

Universitair Medisch Centrum Utrecht ( Site 0351), Utrecht

03722

Severance Hospital Yonsei University Health System ( Site 0836), Seoul

05505

Asan Medical Center ( Site 0830), Seoul

06351

Samsung Medical Center ( Site 0831), Seoul

06591

The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0839), Seoul

08308

Korea University Guro Hospital ( Site 0832), Seoul

08035

Hospital General Universitari Vall d Hebron ( Site 0432), Barcelona

01250

Baskent University Adana Training Hospital ( Site 0499), Adana

06100

Hacettepe University Faculty of Medicine ( Site 0498), Ankara

06200

Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0494), Ankara

06500

Gazi Universitesi Tip Fakultesi ( Site 0496), Ankara

AB252ZN

Aberdeen Royal Infirmary ( Site 0529), Aberdeen

NW3 2QG

Royal Free London NHS Foundation Trust ( Site 0520), London

SW3 6JJ

Royal Marsden Hospital ( Site 0536), London

W12 0HS

Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 0525), London

SM2 5PT

Royal Marsden NHS Foundation Trust ( Site 0535), Sutton

BT9 7AB

Belfast City Hospital ( Site 0517), Belfast

CV2 2DX

University Hospital Coventry and Warwickshire NHS Trust ( Site 0518), Coventry

M20 4BX

The Christie NHS Foundation Trust ( Site 0537), Manchester

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

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) | Biotech Hunter | Biotech Hunter