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) (KEYNOTE-966)

March 4, 2026 updated by: Merck Sharp & Dohme LLC

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1069

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • CABA, Argentina, C1264AAA
        • Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0580)
      • La Rioja, Argentina, F5300COE
        • Centro Oncologico Riojano Integral ( Site 0584)
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, C1431FWO
        • CEMIC ( Site 0581)
      • Ciudad de Buenos Aires, Buenos Aires F.D., Argentina, C1093AAS
        • Fundacion Favaloro ( Site 0578)
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000IAK
        • Centro Medico San Roque ( Site 0579)
  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Liverpool Hospital ( Site 0707)
      • Port Macquarie, New South Wales, Australia, 2444
        • Mid North Coast Cancer Institute ( Site 0708)
    • Queensland
      • Brisbane, Queensland, Australia, 4120
        • Gallipoli Medical Research Foundation ( Site 0705)
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Eastern Health ( Site 0704)
      • St Albans, Victoria, Australia, 3021
        • Western Health-Sunshine Hospital ( Site 0709)
  • Belgium
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • UZA University Hospital Antwerp ( Site 0202)
    • Bruxelles-Capitale, Region de
      • Brussels, Bruxelles-Capitale, Region de, Belgium, 1070
        • Erasme Hospital ( Site 0204)
      • Brussels, Bruxelles-Capitale, Region de, Belgium, 1200
        • Saint-Luc UCL ( Site 0200)
    • Hainaut
      • Charleroi, Hainaut, Belgium, 6000
        • Grand Hopital de Charleroi ( Site 0206)
    • Liege
      • Liège, Liege, Belgium, 4000
        • CHU de Liege ( Site 0201)
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent ( Site 0203)
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • UZ Leuven ( Site 0205)
  • Brazil
      • Rio de Janeiro, Brazil, 22793-080
        • Instituto COI de Pesquisa Educacao e Gestao ( Site 0606)
      • São Paulo, Brazil, 01246-000
        • Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0607)
      • São Paulo, Brazil, 01321-001
        • Hospital Paulistano - Amil Clinical Research ( Site 0603)
      • São Paulo, Brazil, 01321-001
        • Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0609)
      • São Paulo, Brazil, 01509-900
        • A.C. Camargo Cancer Center ( Site 0600)
    • Minas Gerais
      • Nova Lima, Minas Gerais, Brazil, 34000-000
        • Oncobio Servicos de Saude SA ( Site 0604)
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brazil, 98700-000
        • Hospital de Caridade de Ijui ( Site 0602)
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-001
        • Associacao Hospitalar Moinhos de Vento ( Site 0599)
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Hospital de Clinicas de Porto Alegre ( Site 0610)
      • Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
        • Hospital Nossa Senhora da Conceicao ( Site 0601)
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre ( Site 0184)
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute ( Site 0183)
    • Ontario
      • Hamilton, Ontario, Canada, L8V5C2
        • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0182)
    • Quebec
      • Montreal, Quebec, Canada, H2X 3E4
        • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0180)
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre ( Site 0179)
  • Chile
    • Coquimbo Region
      • La Serena, Coquimbo Region, Chile, 1720430
        • IC La Serena Research ( Site 0630)
    • Lbtdr Gen Bernardo O Higgins
      • Rancagua, Lbtdr Gen Bernardo O Higgins, Chile, 2852424
        • Servicios Medicos Urumed ( Site 0621)
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 7500921
        • Fundacion Arturo Lopez Perez FALP ( Site 0623)
      • Santiago, Region M. de Santiago, Chile, 7510032
        • Sociedad Oncovida S.A. ( Site 0626)
      • Santiago, Region M. de Santiago, Chile, 8330032
        • Pontificia Universidad Catolica de Chile ( Site 0620)
    • Región de la Araucanía
      • Temuco, Región de la Araucanía, Chile, 4780000
        • Centro Investigación del Cáncer James Lind ( Site 0622)
  • China
    • Anhui
      • Hefei, Anhui, China, 230001
        • Anhui Provincial Hospital ( Site 0140)
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100036
        • Beijing Cancer Hospital ( Site 0138)
      • Beijing, Beijing Municipality, China, 100730
        • Peking Union Medical College Hospital ( Site 0150)
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400038
        • First Affiliated Hospital of The Third Military Medical University ( Site 0130)
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Fujian Provincial Cancer Hospital ( Site 0154)
      • Fuzhou, Fujian, China, 350025
        • 900 Hospital of the Joint ( Site 0137)
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Guangdong Provincial People s Hospital ( Site 0161)
    • Hainan
      • Changsha, Hainan, China, 410013
        • The Third Xiangya Hospital of Central South University ( Site 0157)
    • Heilongjiang
      • Harbin, Heilongjiang, China, 610000
        • Harbin Medical University Cancer Hospital ( Site 0133)
    • Hunan
      • Changsha, Hunan, China, 410005
        • Hunan Provincial People Hospital ( Site 0142)
      • Changsha, Hunan, China, 410013
        • Hunan Cancer Hospital ( Site 0132)
    • Jiangsu
      • Nanjing, Jiangsu, China, 210031
        • The 81st Hospital of PLA ( Site 0128)
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University ( Site 0131)
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Zhongshan Hospital Fudan University ( Site 0129)
      • Shanghai, Shanghai Municipality, China, 200127
        • Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0158)
      • Shanghai, Shanghai Municipality, China, 201315
        • Fudan University Shanghai Cancer Center ( Site 0160)
    • Shanxi
      • Xi’an, Shanxi, China, 710038
        • Tangdu Hospital ( Site 0146)
      • Xi’an, Shanxi, China, 710048
        • The First Affiliated Hospital of Xi an Jiaotong University ( Site 0145)
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital of Sichuan University ( Site 0147)
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Tianjin Medical University Cancer Institute & Hospital ( Site 0155)
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • The First Affiliated Hospital Zhejiang University ( Site 0136)
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital ( Site 0134)
  • France
    • Gironde
      • Pessac, Gironde, France, 33604
        • CHU Bordeaux Haut-Leveque Centre Francois Magendie ( Site 0245)
    • Hauts-de-Seine
      • Clichy, Hauts-de-Seine, France, 92110
        • A.P.H. Paris, Hopital Beaujon ( Site 0247)
    • Herault
      • Montpellier, Herault, France, 34295
        • CHU de Montpellier - Hopital Saint-Eloi ( Site 0248)
    • Ille-et-Vilaine
      • Rennes, Ille-et-Vilaine, France, 35042
        • Centre Eugene Marquis ( Site 0242)
    • Puy-de-Dome
      • Clermont-Ferrand, Puy-de-Dome, France, 63003
        • CHU Clermont-Ferrand - Site Estaing ( Site 0249)
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94805
        • Gustave Roussy ( Site 0244)
  • Germany
      • Berlin, Germany, 10117
        • Charite - Universtitatsmedizin Berlin CCM ( Site 0269)
      • Hamburg, Germany, 20246
        • Universitaetsklinikum Hamburg-Eppendorf ( Site 0268)
    • Baden-Wurttemberg
      • Ulm, Baden-Wurttemberg, Germany, 89081
        • Universitaetsklinikum Ulm ( Site 0267)
    • Bavaria
      • Munich, Bavaria, Germany, 81377
        • Klinikum der Ludwig - Maximilian Universitat Munchen ( Site 0264)
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60488
        • Krankenhaus Nordwest ( Site 0266)
    • Lower Saxony
      • Hanover, Lower Saxony, Germany, 30625
        • Medizinische Hochschule Hannover ( Site 0265)
    • North Rhine-Westphalia
      • Aachen, North Rhine-Westphalia, Germany, 52074
        • Universitaetsklinikum Aachen AOER ( Site 0275)
      • Cologne, North Rhine-Westphalia, Germany, 50937
        • Universitaetsklinikum Koeln ( Site 0274)
      • Essen, North Rhine-Westphalia, Germany, 45147
        • Universitaetsklinikum Essen ( Site 0273)
    • Saxony
      • Dresden, Saxony, Germany, 01067
        • Staedtisches Klinikum Dresden ( Site 0272)
    • Saxony-Anhalt
      • Magdeburg, Saxony-Anhalt, Germany, 39120
        • Universitaetsklinikum Magdeburg A.o.R. ( Site 0271)
  • Hong Kong
      • Hong Kong, Hong Kong
        • 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)
      • Kowloon, Hong Kong
        • Queen Elizabeth Hospital. ( Site 0854)
  • Ireland
      • Cork, Ireland, T12 DC4A
        • Cork University Hospital ( Site 0538)
      • Cork, Ireland, T12 DV56
        • Bon Secours Hospital ( Site 0526)
      • Dublin, Ireland, D24 NROA
        • Tallaght University Hospital ( Site 0522)
      • Dublin, Ireland, DO4 YN63
        • St Vincents University Hospital ( Site 0521)
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Medical Center ( Site 0308)
      • Jerusalem, Israel, 9112001
        • Hadassah Ein Karem - Sharett Institute of Oncology ( Site 0309)
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center ( Site 0307)
      • Tel Aviv, Israel, 6423906
        • Sourasky Medical Center ( Site 0306)
  • Italy
      • Bologna, Italy, 40138
        • Policlinico S. Orsola-Malpighi ( Site 0333)
      • Catania, Italy, 95124
        • A.O. di Rilievo Nazionale e di alta Specializzazione Garibaldi ( Site 0330)
      • Milan, Italy, 20162
        • ASST Grande Ospedale Metropolitano Niguarda ( Site 0332)
      • Pisa, Italy, 56127
        • Azienda Ospedaliero Universitaria Pisana ( Site 0326)
      • Roma, Italy, 00128
        • Policlinico Universitario Campus Biomedico ( Site 0328)
      • Verona, Italy, 37134
        • Azienda Ospedaliera Universitaria di Verona ( Site 0334)
    • Abruzzo
      • Rome, Abruzzo, Italy, 00168
        • Universita Cattolica del Sacro Cuore - Policlinico Gemelli ( Site 0329)
  • Japan
      • Fukuoka, Japan, 811-1395
        • National Hospital Organization Kyushu Cancer Center ( Site 0078)
      • Kyoto, Japan, 606-8507
        • Kyoto University Hospital ( Site 0083)
      • Osaka, Japan, 541-8567
        • Osaka International Cancer Institute ( Site 0084)
      • Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital of JFCR ( Site 0082)
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 464-8681
        • Aichi Cancer Center Hospital ( Site 0080)
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East ( Site 0081)
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650-0047
        • Kobe City Medical Center General Hospital ( Site 0087)
    • Kagawa-ken
      • Kita-gun, Kagawa-ken, Japan, 761-0793
        • Kagawa University Hospital ( Site 0086)
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 241-8515
        • Kanagawa Cancer Center ( Site 0079)
    • Osaka
      • Suita, Osaka, Japan, 565-0871
        • Osaka University Hospital ( Site 0085)
    • Tokyo
      • Mitaka, Tokyo, Japan, 181-8611
        • Kyorin University Hospital ( Site 0077)
  • Malaysia
      • Kuala Lumpur, Malaysia, 50586
        • Hospital Kuala Lumpur ( Site 0768)
      • Kuala Lumpur, Malaysia, 59100
        • Pantai Hospital Kuala Lumpur ( Site 0771)
    • Johor
      • Johor Bahru, Johor, Malaysia, 81100
        • Hospital Sultan Ismail ( Site 0772)
    • Kuala Lumpur
      • Lembah Pantai, Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre ( Site 0770)
    • Pulau Pinang
      • George Town, Pulau Pinang, Malaysia, 10990
        • Hospital Pulau Pinang ( Site 0773)
    • Putrajaya
      • Putrajaya, Putrajaya, Malaysia, 62250
        • Institut Kanser Negara - National Cancer Institute ( Site 0767)
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • UMCG ( Site 0349)
      • Utrecht, Netherlands, 3584 CX
        • Universitair Medisch Centrum Utrecht ( Site 0351)
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
        • Maastricht University Medical Centre ( Site 0347)
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1105 AZ
        • AMC ( Site 0348)
    • South Holland
      • Rotterdam, South Holland, Netherlands, 3015 GD
        • Erasmus University Medical Center ( Site 0352)
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland City Hospital ( Site 0725)
  • South Korea
      • Seoul, South Korea, 03722
        • Severance Hospital Yonsei University Health System ( Site 0836)
      • Seoul, South Korea, 05505
        • Asan Medical Center ( Site 0830)
      • Seoul, South Korea, 06351
        • Samsung Medical Center ( Site 0831)
      • Seoul, South Korea, 06591
        • The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0839)
      • Seoul, South Korea, 08308
        • Korea University Guro Hospital ( Site 0832)
    • Jeonranamdo
      • Hwasun Gun, Jeonranamdo, South Korea, 58128
        • Chonnam National University Hwasun Hospital ( Site 0837)
    • Kyonggi-do
      • Seongnam, Kyonggi-do, South Korea, 13496
        • CHA Bundang Medical Center CHA University ( Site 0835)
      • Seongnam-si, Kyonggi-do, South Korea, 13605
        • Seoul National University Bundang Hospital ( Site 0833)
      • Suwon, Kyonggi-do, South Korea, 16499
        • Ajou University Hospital, Clinical Research Center ( Site 0838)
    • Taegu-Kwangyokshi
      • Daegu, Taegu-Kwangyokshi, South Korea, 41404
        • Kyungpook National University Chilgok Hospital ( Site 0834)
    • Taejon-Kwangyokshi
      • Daejeon, Taejon-Kwangyokshi, South Korea, 35015
        • Chungnam National University Hospital ( Site 0840)
  • Spain
      • Barcelona, Spain, 08035
        • Hospital General Universitari Vall d Hebron ( Site 0432)
      • Madrid, Spain, 28009
        • Hospital General Universitario Gregorio Maranon ( Site 0433)
      • Madrid, Spain, 28050
        • Hospital Universitario HM Sanchinarro ( Site 0435)
      • Málaga, Spain, 29010
        • Hospital Regional Universitario Carlos Haya ( Site 0431)
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain, 33011
        • Hospital Universitario General de Asturias ( Site 0434)
  • Taiwan
      • Kaohsiung City, Taiwan, 833
        • Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0865)
      • Taichung, Taiwan, 40447
        • China Medical University Hospital ( Site 0862)
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital ( Site 0864)
      • Taipei, Taiwan, 10048
        • National Taiwan University Hospital ( Site 0860)
      • Taipei, Taiwan, 112
        • Koo Foundation Sun Yat-Sen Cancer Center ( Site 0863)
      • Taoyuan District, Taiwan, 333
        • Chang Gung Medical Foundation. Linkou ( Site 0853)
    • Taipei
      • Taipei,, Taipei, Taiwan, 112
        • Taipei Veterans General Hospital ( Site 0861)
  • Thailand
      • Chiang Mai, Thailand, 50200
        • Maharaj Nakorn Chiang Mai Hospital ( Site 0887)
      • Khon Kaen, Thailand, 40002
        • Srinagarind Hospital ( Site 0885)
      • Udon Thani, Thailand, 41330
        • Udon Thani Cancer Hospital ( Site 0886)
    • Bangkok
      • Bangkok, Bangkok, Thailand, 10330
        • King Chulalongkorn Memorial Hospital ( Site 0884)
      • Bangkok, Bangkok, Thailand, 10400
        • Ramathibodi Hospital. ( Site 0889)
      • Bangkok, Bangkok, Thailand, 10700
        • Siriraj Hospital ( Site 0888)
    • Changwat Ubon Ratchathani
      • Ubonratchathani, Changwat Ubon Ratchathani, Thailand, 34000
        • Sunpasithiprasong Hospital ( Site 0883)
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01250
        • Baskent University Adana Training Hospital ( Site 0499)
      • Ankara, Turkey (Türkiye), 06100
        • Hacettepe University Faculty of Medicine ( Site 0498)
      • Ankara, Turkey (Türkiye), 06200
        • Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0494)
      • Ankara, Turkey (Türkiye), 06500
        • Gazi Universitesi Tip Fakultesi ( Site 0496)
      • Istanbul, Turkey (Türkiye), 34098
        • Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0506)
      • Istanbul, Turkey (Türkiye), 34722
        • Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0495)
      • Izmir, Turkey (Türkiye), 35520
        • Izmir Medical Park Hospital Department of Medical Oncology ( Site 0502)
      • Kayseri, Turkey (Türkiye), 38039
        • Erciyes Universitesi Tip Fakultesi ( Site 0500)
    • Adana
      • Malatya, Adana, Turkey (Türkiye), 44280
        • Inonu Universitesi Medical Fakultesi ( Site 0501)
  • United Kingdom
      • Belfast, United Kingdom, BT9 7AB
        • Belfast City Hospital ( Site 0517)
      • Coventry, United Kingdom, CV2 2DX
        • University Hospital Coventry and Warwickshire NHS Trust ( Site 0518)
      • Manchester, United Kingdom, M20 4BX
        • The Christie NHS Foundation Trust ( Site 0537)
    • Aberdeen City
      • Aberdeen, Aberdeen City, United Kingdom, AB252ZN
        • Aberdeen Royal Infirmary ( Site 0529)
    • London, City of
      • London, London, City of, United Kingdom, NW3 2QG
        • Royal Free London NHS Foundation Trust ( Site 0520)
      • London, London, City of, United Kingdom, SW3 6JJ
        • Royal Marsden Hospital ( Site 0536)
      • London, London, City of, United Kingdom, W12 0HS
        • Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 0525)
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Royal Marsden NHS Foundation Trust ( Site 0535)
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham Comprehensive Cancer Ctr ( Site 0016)
    • California
      • La Jolla, California, United States, 92093-0698
        • University of California San Diego Moores Cancer Center ( Site 0008)
      • Los Angeles, California, United States, 90404
        • UCLA Hematology/Oncology - Santa Monica ( Site 0014)
      • San Francisco, California, United States, 94158
        • University of California - San Francisco ( Site 0030)
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital ( Site 0011)
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital ( Site 0057)
      • New Haven, Connecticut, United States, 06510
        • Yale University ( Site 0053)
    • Georgia
      • Atlanta, Georgia, United States, 30322-1013
        • Winship Cancer Institute of Emory University ( Site 0013)
      • Marietta, Georgia, United States, 30060
        • Northwest Georgia Oncology Centers PC ( Site 0045)
    • Illinois
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital ( Site 0056)
    • New York
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital ( Site 0059)
      • New York, New York, United States, 10016
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0038)
      • New York, New York, United States, 10032
        • Columbia University/Herbert Irving Cancer Center ( Site 0009)
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma- Stephenson Oklahoma Cancer Center ( Site 0055)
    • Oregon
      • Portland, Oregon, United States, 97239
        • OHSU Center for Health & Healing ( Site 0044)
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Charleston Oncology ( Site 0042)
      • Greenville, South Carolina, United States, 29607
        • Saint Francis Health System ( Site 0051)
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Blue Ridge Cancer Care ( Site 0033)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A (Pembrolizumab+Chemotherapy)
Participants receive pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS gemcitabine, 1000 mg/m^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS cisplatin, 25 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. Eligible participants who stop the initial course of pembrolizumab with stable disease (SD) or better but progress after discontinuation will initiate a second course of pembrolizumab 200 mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with gemcitabine can be stopped at anytime in first or second course due to toxicity or disease progression.
Biological: Pembrolizumab
Pembrolizumab by intravenous (IV) infusion
Other Names:
  • MK-3475
Drug: Gemcitabine
Gemcitabine by IV infusion
Other Names:
  • Gemzar
Drug: Cisplatin
Cisplatin by IV infusion
Other Names:
  • Platinol®
  • Platinol®-AQ
Placebo Comparator: Arm B (Placebo+Chemotherapy)
Participants receive placebo to pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS gemcitabine, 1000 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS cisplatin, 25 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles.
Drug: Gemcitabine
Gemcitabine by IV infusion
Other Names:
  • Gemzar
Drug: Cisplatin
Cisplatin by IV infusion
Other Names:
  • Platinol®
  • Platinol®-AQ
Drug: Placebo
Placebo to pembrolizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to approximately 38 months
Overall survival was defined as the time from randomization to death due to any cause.
Up to approximately 38 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: Up to approximately 26 months
ORR was defined as the percentage of participants who have a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: a ≥30% decrease in the sum of diameters [SOD] of target lesions) as assessed by BICR per RECIST 1.1, which was adjusted for this study to allow a maximum of 10 target lesions in total and 5 per organ.
Up to approximately 26 months
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)
Time Frame: Up to approximately 26 months
PFS was defined as the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by BICR per RECIST 1.1 was presented.
Up to approximately 26 months
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
Time Frame: Up to approximately 38 months
For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until PD or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on BICR with confirmation. The DOR as assessed using RECIST 1.1 for all participants who experienced a confirmed CR or PR was presented.
Up to approximately 38 months
Number of Participants Who Experience One or More Adverse Events (AE)
Time Frame: Up to approximately 65 months
An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. Number of participants who experienced one or more AEs were reported.
Up to approximately 65 months
Number of Participants Who Discontinued Study Intervention Due to an AE
Time Frame: Up to approximately 63 months
An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurs during the course of the study. Number of participants who discontinued study intervention due to an AE were reported.
Up to approximately 63 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2019

Primary Completion (Actual)

December 15, 2022

Study Completion (Actual)

April 1, 2025

Study Registration Dates

First Submitted

June 28, 2019

First Submitted That Met QC Criteria

June 28, 2019

First Posted (Actual)

July 1, 2019

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3475-966
  • MK-3475-966 (Other Identifier: MSD)
  • KEYNOTE-966 (Other Identifier: MSD)
  • 195007 (Registry Identifier: JAPIC-CTI)
  • 2019-000944-82 (EudraCT Number)
  • U1111-1294-1943 (Registry Identifier: UTN)
  • 2023-506657-38-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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